Assent Compliance www.assentcompliance.com provides free informational webinars for the latest in REACH, RoHS, Conflict Mineral and other restricted substances.
Assent Compliance with offices in Canada, US and EU provides consulting services and compliance software to businesses that must comply with local, national or global environmental regulations. Visit Assent Compliance for more information.
11 Methods You Can Use to Meet the RoHS Declaration RequirementJim Kandler
There is more than one way to ‘skin a cat’.
While this presentation is focused on RoHS II, many of the declaration acquisition concepts presented may also be applied to other substance regulations.
Guide for the implementation of the RoHS Directive by manufacturers of electr...Gimélec
The document provides guidance for manufacturers of electrical equipment on implementing the RoHS Directive, which restricts hazardous substances in electrical and electronic equipment. It discusses the scope and definitions of the directive, including exemptions. Products covered include household appliances, IT equipment, lighting, and some tools. Most electrical installation equipment and large industrial tools are excluded. The guidance outlines information to provide to customers, such as clarifying if a product is RoHS compliant and noting that compliance status may change as exemptions are reviewed.
Restriction of Hazardous Substances(RoHS) and REACHAmit Ghai
A historical perspective, current revisions and guidelines for RoHS and REACH compliance. Includes typical case studies, challenges and ways to overcome them
7 Steps - How to Get a CE Marking Certification for Medical Devices?Puneet sharma
The document outlines the 7 steps to obtain CE marking certification for a medical device: 1) Classify the device, 2) Identify relevant standards and regulations, 3) Compile technical documentation and testing results, 4) Appoint a European authorized representative if located outside the EU, 5) Obtain certification from a notified body for class II/III devices or self-certify for class I, 6) Affix the CE marking, and 7) Comply with any national requirements. The service described can assist manufacturers with all aspects of the certification process.
RoHS II Compliance Presentation - Assent ComplianceMatt Whitteker
Assent Compliance hosted a free webinar on January 29th, covering RoHS II Compliance and the changes you will need to implement within your existing RoHS program in order to achieve compliance.
This webinar will address processes and rules to consider when reviewing your current RoHS program for compliance with RoHS II.
The topics of discussion will include:
o Reviewing RoHS
o Reviewing RoHS II
o Changes between RoHS and RoHS II
o CE Marking Implications
o RoHS II Technical Files
o Standards associated with RoHS and RoHS II
o Exemption Expirations
EU Medical Device Regulatory Framework_Dec, 2022Levi Shapiro
Overview of the EU medical technology and digital health regulatory framework by Ulf Grundmann and Elisabeth Kohoutek of King & Spalding LLP. Topics include regulatory scope and definitions, classification and conformity assessment, placing a device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance. MDR covers diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of a disease. ‘Medical Devices’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings. The Regulation covers all devices for cleaning, sterilizing or disinfecting other medical devices, reprocessed single-use medical devices, and certain devices with no intended medical purpose.
11 Methods You Can Use to Meet the RoHS Declaration RequirementJim Kandler
There is more than one way to ‘skin a cat’.
While this presentation is focused on RoHS II, many of the declaration acquisition concepts presented may also be applied to other substance regulations.
Guide for the implementation of the RoHS Directive by manufacturers of electr...Gimélec
The document provides guidance for manufacturers of electrical equipment on implementing the RoHS Directive, which restricts hazardous substances in electrical and electronic equipment. It discusses the scope and definitions of the directive, including exemptions. Products covered include household appliances, IT equipment, lighting, and some tools. Most electrical installation equipment and large industrial tools are excluded. The guidance outlines information to provide to customers, such as clarifying if a product is RoHS compliant and noting that compliance status may change as exemptions are reviewed.
Restriction of Hazardous Substances(RoHS) and REACHAmit Ghai
A historical perspective, current revisions and guidelines for RoHS and REACH compliance. Includes typical case studies, challenges and ways to overcome them
7 Steps - How to Get a CE Marking Certification for Medical Devices?Puneet sharma
The document outlines the 7 steps to obtain CE marking certification for a medical device: 1) Classify the device, 2) Identify relevant standards and regulations, 3) Compile technical documentation and testing results, 4) Appoint a European authorized representative if located outside the EU, 5) Obtain certification from a notified body for class II/III devices or self-certify for class I, 6) Affix the CE marking, and 7) Comply with any national requirements. The service described can assist manufacturers with all aspects of the certification process.
RoHS II Compliance Presentation - Assent ComplianceMatt Whitteker
Assent Compliance hosted a free webinar on January 29th, covering RoHS II Compliance and the changes you will need to implement within your existing RoHS program in order to achieve compliance.
This webinar will address processes and rules to consider when reviewing your current RoHS program for compliance with RoHS II.
The topics of discussion will include:
o Reviewing RoHS
o Reviewing RoHS II
o Changes between RoHS and RoHS II
o CE Marking Implications
o RoHS II Technical Files
o Standards associated with RoHS and RoHS II
o Exemption Expirations
EU Medical Device Regulatory Framework_Dec, 2022Levi Shapiro
Overview of the EU medical technology and digital health regulatory framework by Ulf Grundmann and Elisabeth Kohoutek of King & Spalding LLP. Topics include regulatory scope and definitions, classification and conformity assessment, placing a device on the EU Market, UDI and EUDAMED, Supply Chain Obligations, PMS and Vigilance. MDR covers diagnosis, prevention, monitoring, prediction, prognosis, treatment, or alleviation of a disease. ‘Medical Devices’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings. The Regulation covers all devices for cleaning, sterilizing or disinfecting other medical devices, reprocessed single-use medical devices, and certain devices with no intended medical purpose.
Introduction
Definition
Classification
Regulatory registration procedure
Quality system requirements
Clinical evaluation
Investigation of medical devices
Summary
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration (CFDA)
Manufacturers must register their devices with the NMPA before selling or distributing in China.
The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of compensation for an injury or handicap conditions
Investigation, replacement or modification for anatomy or a physiological process
Control of conception
The Chinese authorities (CFDA/NMPA) have their own quality management system requirements.
However, these “GMP requirements” are very similar to ISO 13485.
Therefore, manufacturers usually submit the ISO 13485 certificate.
However, the audit will review this certificate against the Chinese GMP requirements.
These audits are regularly carried out during the approval procedure and/or after a recall.
NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.
Product Life-cycle Process
The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. Applicant needs to:
Ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
Carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
For lower-risk medical devices (Class I and Class II), clinical evaluation may not always be required. However, higher-risk devices (Class III and implantable devices) generally require clinical evaluation.
The evaluation involves reviewing existing clinical data, scientific literature, and relevant clinical research to assess the safety and performance of the device.
All clinical trials for medical devices must follow China Good Clinical Practices
Clinical investigations are required if no equivalent devices can be found and safety and efficacy cannot be proven with other clinical and non-clinical data.
For certain medical devices, the NMPA may require clinical investigations, especially for novel devices or those with significant risk.
Clinical investigations involve conducting studies on human subjects to generate clinical data on the safety and effectiveness of the device.
ISO 13485 outlines quality management system requirements for medical device manufacturers. It requires organizations to establish documented processes for planning and managing key activities like risk management, product realization, and quality improvement. Records must be maintained to demonstrate conformity to standards. Management is responsible for ensuring adequate resources, communication of quality policies, and regular reviews of the quality system and opportunities for improvement.
REACH is a European Union regulation that addresses the production and use of chemical substances and their potential impacts on human health and the environment. It aims to improve the protection of human health and the environment through better and earlier identification of the intrinsic properties of chemical substances. Key aspects of REACH include the registration, evaluation, authorization and restriction of chemicals. Companies are required to gather information on the properties of their chemical substances and register the information in a central database run by the European Chemicals Agency.
Many products require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health, and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.
When is CE marking mandatory?
CE marking is only obligatory for products for which EU specifications exist and require the affixing of CE marking.
Some products are subject to several EU requirements at the same time. You must make sure that your product complies with all the relevant requirements before affixing the CE marking to it. It is forbidden to affix the CE marking to products for which EU specifications do not exist or do not require the affixing of CE marking.
The document discusses ISO 13485:2016 which is an internationally recognized quality management system standard for medical device organizations. It outlines the key requirements for establishing a quality management system including determining processes, documenting procedures, managing documents and records, ensuring management responsibility and review, controlling purchasing and product realization, and conducting internal audits. The standard aims to help organizations consistently meet regulatory requirements and customer needs for medical devices.
Watch the webinar here: https://bit.ly/2lLquKk
Since 2017 Chinese Health Authority has published new regulation for Co-Review procedure of API, excipient and packaging material. Focusing on the unique regulatory requirement for registration of excipient we will give you an overview about the dossier requirement, ChP compliance and impact for the pharmaceutical industry.
If you want to market your drug into China, are you aware that excipient used in your drug need to be registered and to be compliance wtih Chinese pharmacopoeia? Since 2017 Chinese Health Authority has published new regulation for Co-Review procedure of API, excipient and packaging material. Focusing on the unique regulatory requirement for registration of excipient we will give you an overview about the dossier requirement, ChP compliance and impact for the pharmaceutcal industry.
In this webinar, you will learn:
- Current Chinese regulation for excipient registration
- Chinese pharmacopoeia as standard for the excipients
- Impact of excipient regulation for pharmaceutical industries
1) The document outlines the ISO 13485 and FDA requirements for design and development of medical devices. It discusses design and development planning, inputs, outputs, review, verification, validation, transfer, changes, and documentation.
2) Key aspects that must be planned for include design stages and reviews, verification and validation activities, responsibilities, and resource needs. Design inputs must address intended use, standards, and risk management outputs.
3) Design outputs must meet inputs and specify characteristics essential for safe use. Design reviews evaluate ability to meet requirements. Verification confirms meeting inputs while validation confirms meeting intended use. Proper transfer to manufacturing is required.
REACH is a European Union regulation that addresses the production and use of chemical substances and their potential impacts on human health and the environment. It requires companies to register manufactured or imported chemical substances and provides authorities with powers to check companies are managing risks appropriately and substituting potentially dangerous chemicals. Substances of very high concern require authorization for use. REACH also updates chemical labeling and safety data sheet requirements. The key requirement is that companies must evaluate chemical hazards and demonstrate appropriate risk management measures are implemented across the supply chain.
This presentation consist of what ISO 13485 is and why is it important to consider this standard while designing a medical device. It will help u understand what Quality actual is and its importance in medical device industry. It gives you insight about quality management system and its documentation.
This document provides an overview of CE marking requirements for medical devices being sold in the European Union. It explains that CE marking demonstrates compliance with European safety and performance standards and is required for medical devices to enter the EU market. The document outlines the classification of medical devices, the benefits of CE marking, applicable directives, requirements for affixing the marking and generating the necessary technical documentation and declaration of conformity.
CE marking and CE certification what is it why you need it who can apply
CE marking certification for medical devices. Medical Device Regulations. It Is Easy To Make Mistakes In The Regulatory Process That Can Delay.
Visit: http://www.meddevicecorp.com/
Understanding Post-market Surveillance under EU MDR: Being Proactive, not Rea...Greenlight Guru
While the enforcement of EU MDR might have been delayed another year, your preparations addressing requirements for post-market surveillance (PMS) should not be! These new PMS requirements push manufacturers to take a more active role in monitoring of their devices to ensure that the benefit-risk profile of the device remains current. Performing PMS activities, according to the risk class of the device, requires a cross-functional team to ensure the required sources of data can be accessed and accurate data gathered. In this session, learn why it is important that PMS is not a one-size fits all approach, with considerations for risk of device, lifetime of device, time of the market, and more.
Talk takeaways:
• Understanding the new requirements of PMS under MDR
• What is the impact to the business?
• How do the requirements affect your current product lifecycle approach/QMS?
• Relationship between PMCF and PMS
• What to include in your plans and reports?
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
The Restriction of Hazardous Substances (RoHS) Manual for SMEszubeditufail
This document provides guidance on compliance with the RoHS Directive, which restricts the use of certain hazardous substances in electrical and electronic equipment. It defines key terms used in the RoHS Directive and requirements. It also discusses how producers can control parts to ensure compliance and how suppliers can establish their own parts control processes. Case studies from Korea, Japan, and China are presented to demonstrate how companies implement RoHS compliance in practice. The document aims to help small and medium enterprises understand and comply with RoHS requirements to maintain access to markets in the European Union.
How to Prepare for the New EU Medical Device Regulations (MDR)Greenlight Guru
The new MDR is expected to be formally published in late 2016 or early 2017, and there will be a three-year transition period to be compliant.
Many forward thinking medical device companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
In this presentation you will learn:
-Why the European regulations are changing
-An overview of the text being voted on
-What does the new regulation mean for manufactures
-Examine the risk based approach to classification
-Strategy for technical documentation preparation
-Changes to clinical evidence for devices
-Post market surveillance and vigilance for medical devices
-What you can do to start preparing now
-What are all the significant changes
You can watch the recording of this presentation here: https://www.greenlight.guru/webinar/eu-medical-device-regulations-mdr
Brazil Cosmetics Regulations by ArtixioAndyThomas119
Cosmetics in Brazil are classified as Class I and Class II products based on the risk involved. In the Brazilian Market there are two ways of product authorization - registration and prior notification of a product exempted of registration.
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...Pallavi Christeen
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims. Additional benefits may include your product being made safer for end-users. The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the member’s states of the European Economic Area (EEA), then you must apply CE marking to your product against the essential requirements of all these applicable directives.
Key Words: European Union, CE marking, New Approach Directives, EEA, Regulatory requirements.
Understanding the New ISO 13485:2016 RevisionGreenlight Guru
he much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late last month (Feb, 2016).
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here (http://www.greenlight.guru/webinar/iso-13485-2016-changes).
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-transition-planning)
In this webinar, you'll learn specifically:
What your organization needs to be doing to prepare for the transition to ISO 13485:2016
Why the transition presents an opportunity for your organization to implement better processes
An overview of the specific changes coming with ISO 13485:2016
The actions you should be taking now and how to plan for the implementation of the standard
The document provides an overview of the Common Technical Document (CTD) format for regulatory drug dossiers. The CTD format organizes a drug application into five modules, with Modules 2-5 constituting the core CTD. Module 2 contains summaries of quality, nonclinical, and clinical information from Modules 3-5. It outlines the content and format requirements for key summaries in Module 2, including the Quality Overall Summary, Nonclinical Overview, Clinical Overview, and other summaries. The CTD format aims to create a well-organized, consistent structure across regions to facilitate regulatory review of drug applications.
Assent Compliance hosts regular webinars which cover compliance for REACH, RoHS , CLP and many other environmental regulations. To view the web cast online visit www.assentcompliance.com
Material Declarations For Any Environmental RegulationMatt Whitteker
Assent Compliance host regular web casts. This is the first presentation in our Spring 2012 Web Series on Material Declarations For Any Environmental Regulation. Visit www.assentcompliance.com for more information.
Introduction
Definition
Classification
Regulatory registration procedure
Quality system requirements
Clinical evaluation
Investigation of medical devices
Summary
Medical devices are regulated by the National Medical Product Administration (NMPA), formerly the China Food and Drug Administration (CFDA)
Manufacturers must register their devices with the NMPA before selling or distributing in China.
The NMPA reviews all device applications and has strict requirements for submission documentation, testing, and clinical data.
Any instrument, apparatus, appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application.
Diagnosis, prevention, monitoring, treatment or alleviation of disease
Diagnosis, monitoring, treatment, alleviation of compensation for an injury or handicap conditions
Investigation, replacement or modification for anatomy or a physiological process
Control of conception
The Chinese authorities (CFDA/NMPA) have their own quality management system requirements.
However, these “GMP requirements” are very similar to ISO 13485.
Therefore, manufacturers usually submit the ISO 13485 certificate.
However, the audit will review this certificate against the Chinese GMP requirements.
These audits are regularly carried out during the approval procedure and/or after a recall.
NMPA issued and implemented the "Guideline on Inspection of Quality Management System for Medical Device Registration" on October 10, 2022.
Product Life-cycle Process
The guideline specifies the basic requirements for registration inspection, self-inspection, commissioned inspection, and extended inspection, etc. Applicant needs to:
Ensure the design, development, production, and other process data to be true, accurate, complete, and traceable, and consistent with the registration application materials.
Carry out the registration QMS inspection in reference to the registration application materials, and focus on the design, development, procurement, production management, and quality control of the product.
For lower-risk medical devices (Class I and Class II), clinical evaluation may not always be required. However, higher-risk devices (Class III and implantable devices) generally require clinical evaluation.
The evaluation involves reviewing existing clinical data, scientific literature, and relevant clinical research to assess the safety and performance of the device.
All clinical trials for medical devices must follow China Good Clinical Practices
Clinical investigations are required if no equivalent devices can be found and safety and efficacy cannot be proven with other clinical and non-clinical data.
For certain medical devices, the NMPA may require clinical investigations, especially for novel devices or those with significant risk.
Clinical investigations involve conducting studies on human subjects to generate clinical data on the safety and effectiveness of the device.
ISO 13485 outlines quality management system requirements for medical device manufacturers. It requires organizations to establish documented processes for planning and managing key activities like risk management, product realization, and quality improvement. Records must be maintained to demonstrate conformity to standards. Management is responsible for ensuring adequate resources, communication of quality policies, and regular reviews of the quality system and opportunities for improvement.
REACH is a European Union regulation that addresses the production and use of chemical substances and their potential impacts on human health and the environment. It aims to improve the protection of human health and the environment through better and earlier identification of the intrinsic properties of chemical substances. Key aspects of REACH include the registration, evaluation, authorization and restriction of chemicals. Companies are required to gather information on the properties of their chemical substances and register the information in a central database run by the European Chemicals Agency.
Many products require CE marking before they can be sold in the EU. CE marking indicates that a product has been assessed by the manufacturer and deemed to meet EU safety, health, and environmental protection requirements. It is required for products manufactured anywhere in the world that are then marketed in the EU.
When is CE marking mandatory?
CE marking is only obligatory for products for which EU specifications exist and require the affixing of CE marking.
Some products are subject to several EU requirements at the same time. You must make sure that your product complies with all the relevant requirements before affixing the CE marking to it. It is forbidden to affix the CE marking to products for which EU specifications do not exist or do not require the affixing of CE marking.
The document discusses ISO 13485:2016 which is an internationally recognized quality management system standard for medical device organizations. It outlines the key requirements for establishing a quality management system including determining processes, documenting procedures, managing documents and records, ensuring management responsibility and review, controlling purchasing and product realization, and conducting internal audits. The standard aims to help organizations consistently meet regulatory requirements and customer needs for medical devices.
Watch the webinar here: https://bit.ly/2lLquKk
Since 2017 Chinese Health Authority has published new regulation for Co-Review procedure of API, excipient and packaging material. Focusing on the unique regulatory requirement for registration of excipient we will give you an overview about the dossier requirement, ChP compliance and impact for the pharmaceutical industry.
If you want to market your drug into China, are you aware that excipient used in your drug need to be registered and to be compliance wtih Chinese pharmacopoeia? Since 2017 Chinese Health Authority has published new regulation for Co-Review procedure of API, excipient and packaging material. Focusing on the unique regulatory requirement for registration of excipient we will give you an overview about the dossier requirement, ChP compliance and impact for the pharmaceutcal industry.
In this webinar, you will learn:
- Current Chinese regulation for excipient registration
- Chinese pharmacopoeia as standard for the excipients
- Impact of excipient regulation for pharmaceutical industries
1) The document outlines the ISO 13485 and FDA requirements for design and development of medical devices. It discusses design and development planning, inputs, outputs, review, verification, validation, transfer, changes, and documentation.
2) Key aspects that must be planned for include design stages and reviews, verification and validation activities, responsibilities, and resource needs. Design inputs must address intended use, standards, and risk management outputs.
3) Design outputs must meet inputs and specify characteristics essential for safe use. Design reviews evaluate ability to meet requirements. Verification confirms meeting inputs while validation confirms meeting intended use. Proper transfer to manufacturing is required.
REACH is a European Union regulation that addresses the production and use of chemical substances and their potential impacts on human health and the environment. It requires companies to register manufactured or imported chemical substances and provides authorities with powers to check companies are managing risks appropriately and substituting potentially dangerous chemicals. Substances of very high concern require authorization for use. REACH also updates chemical labeling and safety data sheet requirements. The key requirement is that companies must evaluate chemical hazards and demonstrate appropriate risk management measures are implemented across the supply chain.
This presentation consist of what ISO 13485 is and why is it important to consider this standard while designing a medical device. It will help u understand what Quality actual is and its importance in medical device industry. It gives you insight about quality management system and its documentation.
This document provides an overview of CE marking requirements for medical devices being sold in the European Union. It explains that CE marking demonstrates compliance with European safety and performance standards and is required for medical devices to enter the EU market. The document outlines the classification of medical devices, the benefits of CE marking, applicable directives, requirements for affixing the marking and generating the necessary technical documentation and declaration of conformity.
CE marking and CE certification what is it why you need it who can apply
CE marking certification for medical devices. Medical Device Regulations. It Is Easy To Make Mistakes In The Regulatory Process That Can Delay.
Visit: http://www.meddevicecorp.com/
Understanding Post-market Surveillance under EU MDR: Being Proactive, not Rea...Greenlight Guru
While the enforcement of EU MDR might have been delayed another year, your preparations addressing requirements for post-market surveillance (PMS) should not be! These new PMS requirements push manufacturers to take a more active role in monitoring of their devices to ensure that the benefit-risk profile of the device remains current. Performing PMS activities, according to the risk class of the device, requires a cross-functional team to ensure the required sources of data can be accessed and accurate data gathered. In this session, learn why it is important that PMS is not a one-size fits all approach, with considerations for risk of device, lifetime of device, time of the market, and more.
Talk takeaways:
• Understanding the new requirements of PMS under MDR
• What is the impact to the business?
• How do the requirements affect your current product lifecycle approach/QMS?
• Relationship between PMCF and PMS
• What to include in your plans and reports?
This session took place live at the Greenlight Guru True Quality Virtual Summit, a three-day event for medical device professionals to learn to get their devices to market faster, stay ahead of regulatory changes, and use quality as their multiplier to grow their device business.
The Restriction of Hazardous Substances (RoHS) Manual for SMEszubeditufail
This document provides guidance on compliance with the RoHS Directive, which restricts the use of certain hazardous substances in electrical and electronic equipment. It defines key terms used in the RoHS Directive and requirements. It also discusses how producers can control parts to ensure compliance and how suppliers can establish their own parts control processes. Case studies from Korea, Japan, and China are presented to demonstrate how companies implement RoHS compliance in practice. The document aims to help small and medium enterprises understand and comply with RoHS requirements to maintain access to markets in the European Union.
How to Prepare for the New EU Medical Device Regulations (MDR)Greenlight Guru
The new MDR is expected to be formally published in late 2016 or early 2017, and there will be a three-year transition period to be compliant.
Many forward thinking medical device companies are already developing their plans for compliance now to gain strategic advantages over their competitors.
In this presentation you will learn:
-Why the European regulations are changing
-An overview of the text being voted on
-What does the new regulation mean for manufactures
-Examine the risk based approach to classification
-Strategy for technical documentation preparation
-Changes to clinical evidence for devices
-Post market surveillance and vigilance for medical devices
-What you can do to start preparing now
-What are all the significant changes
You can watch the recording of this presentation here: https://www.greenlight.guru/webinar/eu-medical-device-regulations-mdr
Brazil Cosmetics Regulations by ArtixioAndyThomas119
Cosmetics in Brazil are classified as Class I and Class II products based on the risk involved. In the Brazilian Market there are two ways of product authorization - registration and prior notification of a product exempted of registration.
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...Pallavi Christeen
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims. Additional benefits may include your product being made safer for end-users. The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the member’s states of the European Economic Area (EEA), then you must apply CE marking to your product against the essential requirements of all these applicable directives.
Key Words: European Union, CE marking, New Approach Directives, EEA, Regulatory requirements.
Understanding the New ISO 13485:2016 RevisionGreenlight Guru
he much anticipated revision to ISO 13485, the global medical device quality management system (QMS) standard, was released late last month (Feb, 2016).
The new ISO 13485:2016 ushers in a whole new wave of changes and requirements medical device manufacturers must adhere to, which we covered on our previous webinar here (http://www.greenlight.guru/webinar/iso-13485-2016-changes).
ISO tells us that there will be a three year transition period after which the guidance says, “any existing certification issued to ISO 13485:2003 will not be valid.”
The time to start planning your organization's transition to ISO 13485:2016 is now. Or face playing expensive catch up later.
(You can view the full webinar here: http://www.greenlight.guru/webinar/iso-13485-2016-transition-planning)
In this webinar, you'll learn specifically:
What your organization needs to be doing to prepare for the transition to ISO 13485:2016
Why the transition presents an opportunity for your organization to implement better processes
An overview of the specific changes coming with ISO 13485:2016
The actions you should be taking now and how to plan for the implementation of the standard
The document provides an overview of the Common Technical Document (CTD) format for regulatory drug dossiers. The CTD format organizes a drug application into five modules, with Modules 2-5 constituting the core CTD. Module 2 contains summaries of quality, nonclinical, and clinical information from Modules 3-5. It outlines the content and format requirements for key summaries in Module 2, including the Quality Overall Summary, Nonclinical Overview, Clinical Overview, and other summaries. The CTD format aims to create a well-organized, consistent structure across regions to facilitate regulatory review of drug applications.
Assent Compliance hosts regular webinars which cover compliance for REACH, RoHS , CLP and many other environmental regulations. To view the web cast online visit www.assentcompliance.com
Material Declarations For Any Environmental RegulationMatt Whitteker
Assent Compliance host regular web casts. This is the first presentation in our Spring 2012 Web Series on Material Declarations For Any Environmental Regulation. Visit www.assentcompliance.com for more information.
Assent Compliance Guide for 2011 REACH/RoHSMatt Whitteker
RoHS, CLP and REACH Guide for 2011. Assent Compliance provides expert consulting and software solutions for local, national and global environmental regulations. Visit www.assentcompliance.com for more information
Inspecta give you a short presentation of our vision, business idea and values, why you should coose Inspecta and what we do, our managing directors thoughts of the future and the role of recertification
This document provides an overview of structural design codes internationally. It discusses the Construction Products Directive and Eurocodes implemented in Europe to harmonize building regulations across countries. The Construction Products Directive establishes six essential performance requirements for construction products. Countries can comply via harmonized European standards or European Technical Approval. The Eurocodes define building performance and contain formulas to calculate structural design. They have been adopted by several European countries who have published National Application Documents.
The document provides an overview of standards and standardization for nanotechnologies. It discusses why standards are important for nanotechnologies, the roles and types of standards, and major international organizations developing standards including ISO, IEC, CEN, and BSI. It outlines some key challenges for nanotechnology standardization and provides examples of existing and in-development standards.
The document provides an overview of standardization efforts for nanotechnologies. It discusses the importance of standards to ensure safe and responsible development. It outlines the roles of key international standardization committees (ISO, IEC, CEN) and describes their activities, including published standards, work programs, and areas of focus like terminology, measurement, and health/safety. Coordination across committees and with other stakeholders is emphasized to develop standards efficiently.
The document provides an overview of standardization efforts for nanotechnologies. It discusses the importance of standards to ensure safe and responsible development. It outlines the roles of key international standardization committees (ISO, IEC, CEN) and describes their activities, including published standards, work programs, and areas of focus like terminology, measurement, and health/safety. Coordination across committees and with other stakeholders is emphasized to develop standards efficiently.
Who needs a CE mark and how do I get one? It is EU law that every product that enters the European Union meet the CE Directives and applicable Standards. This mark can only be applied to your product when you have fully complied with all relevant Directives and Standards for the type of system you are marketing and and a Declaration of Conformity has been developed.
The document outlines the professional experience, qualifications, and credentials of Dr. Aziz U. Rehman, including over 20 years of experience in reliability engineering, asset integrity management, non-destructive testing, and project/program management. It details his educational background, professional designations, roles held at various companies, and accomplishments on projects involving structural health monitoring, pipeline inspection, and developing training programs. The document provides Dr. Rehman's contact information and an extensive list of his professional certifications in areas such as engineering, non-destructive testing, project management, quality, and welding.
The IEC CB (Certified Body) scheme is the largest international product certification scheme.
The scheme is the world’s first truly international system for mutual acceptance of test reports and certificates dealing with safety of electrical and electronic components, equipment and products.
A CB-certificate is documentation of product compliance with the relevant standard. A certificate gives access to, and simplifies national certification, in more than 60 member nations and is also widely recognized in other countries.
Assent Compliance hosted a free webinar on January 15th, covering the newly released substances on the SVHC list.
This webinar will address the new SVHCs officially added to the candidate list by the ECHA. The topics of discussion will include:
o What are the substances?
o Where are they used?
o A review of what the current Authorization list looks like
o What substances might be included next?
o How can Assent help?
It is essencial to safeguard the value and current recognition of the CE marking by implementing the CPR in a way that the identification of construction products are characterized by the declared performance based on a harmonized technical assessment being the result of national consent.
TÜV NORD GROUP is a certification body that provides standardization and conformity assessment services. It is accredited to certify products according to European standards and notified to assess compliance with European directives. It has international recognition from organizations in the US, Australia, and South Korea. TÜV NORD GROUP has experience in projects involving standardization and certification for security applications in areas like disaster resilience, fighting crime and terrorism, and border security. It is interested in partnering on projects involving standardization, validation, and conformity evaluation of security devices and systems.
TÜV NORD GROUP is a certification body that provides standardization and conformity assessment services. It is accredited in Spain and has international recognition. It has expertise in developing standards, certifying products for compliance, and testing security devices. TÜV NORD GROUP expresses interest in partnering on H2020 projects related to standardization, validation, and certification of security technologies.
This document discusses procedures for loop checking and field instrument testing. It suggests developing standardized procedures to make the process more efficient. Specifically, it proposes: [1] Having a common guideline procedure for loop checking. [2] Illustrating all required drawings, specifications and forms. [3] Creating a flow chart illustrating the process. The comments provide examples of procedures companies use and emphasize the importance of documentation.
Strategic Sourcing Case Study on Aluminum Industry by Dragon SourcingJohn William
Here is a case study by Dragon Sourcing on strategic sourcing case study on Aluminum Industry from industrial product sector for the year 2018 covering China. For details contact: www.dragonsourcing.com
CE marking is a declaration by the manufacturer that a product meets the requirements of the applicable European directives. It allows for free movement of goods within the EU and some non-EU countries. The CE marking must be in the correct format and no smaller than 3mm for small products. While consumers may see CE marking as an indicator of quality, it actually only signifies that a product meets essential safety and regulatory requirements. Technical files must be compiled and maintained by manufacturers to demonstrate a product's compliance through documentation such as standards applied, test reports, and declarations of conformity.
This document summarizes Common Criteria certification statistics from various sources including the CCScraper tool. It provides statistics for 2021 based on data collected up to September 30th, highlighting the top certification schemes, assurance levels, laboratories, product categories and manufacturers. It also analyzes trends over the past 5 years and discusses the impact of the COVID-19 pandemic on certification numbers.
The document provides a profile for ABC Company for Engineering and Contracting (ABCCOM). It outlines the company's vision, values, mission and fields of business which include electrical power systems, HVAC, and firefighting. It also describes ABCCOM's management structure, commitment to customers, and work environment. Finally, it lists the company's key success factors and provides examples of past projects and references for ABCCOM and its experienced team of engineers.
Similar to RoHS Technical File Creation Webinar Slides (20)
EU Conflict Minerals Update -- Amnesty International Report ReviewMatt Whitteker
The document summarizes an Assent Compliance webinar on EU conflict minerals and the Amnesty International report. It discusses:
- The Amnesty International report that found 80% of companies are not fully complying with conflict minerals requirements. There is debate around Amnesty's scoring criteria.
- The new EU conflict minerals law that will require mandatory audits for smelters and refiners, and information from downstream users on supply chain risks. It has a broader global scope than Dodd-Frank.
- Assent's upcoming conflict minerals benchmark report analyzing all 2015 conflict mineral reports against different scoring criteria to provide rankings and scores.
Why Companies Succeed.
Assents CEO presents an insightful look on why companies succeed. Relying on chance alone is not a strategy.
http://www.assentcompliance.com
Reach webinar additional information assent april 2015Matt Whitteker
A possible new interpretation for Articles is on the table but that is not all... There are important lists and annexes associated with REACH compliance that keep updating.
We will review:
• CoRAP - 134 Substance Evaluations
• Restriction Proposal Decisions
• Authorisation Applications
• Registry of Intentions
• Proposed SVHCs
• Recommendations for the Authorization List
We will discuss how these changes affect you and your products. We'll also ensure you know what to focus on and some key tips to practically handle REACH Compliance.
Stock Price and Business Case for ComplianceMatt Whitteker
Assent's latest research paper attempts to clarify the relationship between companies’ environmental compliance strategies, and their profitability (as measured by their stock prices). An independent analysis—performed by two prestigious U.S. institutions: consulting firm Watermark Advisors, and Vanderbilt University’s Owen Graduate School of Management—examined the performance of one hundred publicly traded companies (Assent Customers). As Assent customers, these companies had all invested significantly in their compliance programs.
- Did Their Stock Price Outperform the Market at Large?
- How Much or How Little?
- What Latent Functions Could Investing in Compliance Cause?
- Why Should Companies Invest Vs Do the Bare Minimum?
- What Conclusions Can we Draw About Investing in Compliance.
This document provides guidance on completing the Conflict Minerals Report (CMR) required by the SEC. It discusses the 5 steps companies must include in their CMR: 1) establish strong management systems, 2) identify supply chain risks, 3) design and implement a risk management strategy, 4) conduct third-party audits of smelters/refiners, and 5) report annually on supply chain due diligence. The document advises addressing each step by describing conflict minerals due diligence processes and activities, such as data collection, validation, and smelter verification. It also outlines general CMR completion timelines and provides examples of other companies' CMR filings.
The document discusses the implications of new substances being added to the REACH SVHC (Substances of Very High Concern) list. It provides an overview of companies' legal obligations regarding communicating and notifying the presence of SVHCs in their articles. These substances may also eventually be subject to authorization requirements if they are added to the Authorization list. The presentation covers how SVHCs get added to the Candidate List and the timeline for that process.
CMRT (Conflict Minerals Reporting Template) Data Validation Matt Whitteker
CMRT (Conflict Minerals Reporting Template) Data Validation is the second subject covered in Assents Conflict Mineral 2015 Webinar Series. For information about Conflict Mineral Compliance visit: http://www.AssentCompliance.com
Conflict Minerals Survey -- Tulane University Matt Whitteker
In a follow up survey of companies effected by Dodd Frank Section 1502 Chris Bayer of Tulane university conducted a thorough industry bench-marking survey. The results are broken down in sections:
Profile of affected companies
Internal company resources utilized
External resources utilized
Cost summary
Synergies
Market impact
Good practices
It’s encouraging to note that Assent Compliance was listed as a global top 3 provider of conflict mineral compliance software in terms of adoption rate. A huge thank you to all the Assent customers and suppliers that exchange data on our platform.
You can download the full survey here: Conflict Minerals Survey — Tulane Post Filing
Need a hand with anything compliance related? Email us at Info@AssentCompliance.com
Advancing Compliance Assurance and EHS Management Systems Matt Whitteker
At Assent we’re very active in the compliance community. One of the industry associations we are a proud member and sponsor of is The National Association of EHS Managers (NAEM). It is the largest professional community for corporate environmental, health and safety, and sustainability decision-makers. Assent recently attended NAEM’s Advancing Compliance Assurance and EHS Management Systems conference and was able to get some great insights into the topics affecting compliance and EHS managers today. Here was the agenda: http://ehscompliance.naem.org/agenda.php
RoHS Exemption List - Review By: Assent Compliance Matt Whitteker
www.assentcompliance.com
Assent Compliance outlines the RoHS exemption list and associated information. Assent Compliance provides companies with RoHS support and software services. If you need a hand with anything compliance related please email info@assentcompliance.com
REACH Regulation - Frequently Asked Questions Matt Whitteker
http:/www.AssentCompliance.com
Assent Compliance examines the frequently asked questions around the EU REACH regulation.
What is REACH?
How does it apply to me?
What are SVHC's ?
Does the REACH List change?
And many other important questions examined. Need a hand with REACH Compliance? Email info@assentcompliance.com
CMRT 3.01 - Comparison To The EICC Gesi Template Matt Whitteker
The document summarizes changes between versions 2.03 and 3.01 of the Conflict Minerals Reporting Template (CMRT). Major changes include expanded company information fields, modified conflict minerals sourcing questions, and updated smelter information, with new smelter IDs. Over 100 smelters had their IDs changed in the transition to CMRT 3.01.
Conflict Mineral Compliance - Frequently Asked Questions Matt Whitteker
www.assentcompliance.com
Assent Compliance answers the most common frequently asked questions with regards to conflict mineral compliance.
- What are conflict minerals
- What if we are a private company
- What is the difference between the CMRT 3.01 and the previous form
- We do not use 3TG's - What now?
And a host of other FAQ's. If you have any questions about conflict minerals and or conflict mineral compliance email: info@assentcompliance.com
www.assentcompliance.com Assent Compliance looks at psychological mechanisms to improve supplier conversion rates around product compliance and data collection. This unique spin on classic psychology research takes readers through a variety of studies and their application to supply chain. Visit http://www.assentcompliance.com or email info@assentcompliance.com for more information.
Conflict Mineral Compliance Toolkit For Executives Matt Whitteker
Assent Compliance was the only software vendor that the SEC consulted with when passing the Conflict Minerals legislation. Assent has been on the ground floor and has been able to work with over 20% of S&P 500 companies in scope of the law. We've compiled this Ebook to assist with companies that need to comply. This is a play book with everything you need to know. If you want more information visit http://www.assentcompliance.com or email info@assentcompliance.com
Product Compliance Software Vendor Sourcing Guide Matt Whitteker
Choosing a Product Compliance Software / Services Vendor can be a daunting prospect. At Assent we've made things easy with the following guide. We look at best practices, different service, business models and give you an indepth look at how to source a product compliance vendor for software and services.
CMRT 3.01 Different Between EICC - Gesi Form Matt Whitteker
The CMRT 3.01 form has replaced the previous EICC Gesi form for conflict mineral reporting. The CMRT 3.01 is now the industry standard reporting form. This presentation by Assent Compliance outlines the differences between the previous template and the new one. If you need any help with conflict minerals compliance or would like clarification on this document please do not hesitate to contact info@assentcompliance.com or visit at http://www.assentcompliance.com
This document discusses strategies for early adopters in a new business. It recommends making early adopters love the product through a feedback loop to refine it. Learn from mistakes but improve the product and monitor customer acquisition costs and lifetime value. Early adopters may be different than expected. Once strong references are built, target other customer segments gradually. The funnel must be defined and won over segment by segment before expanding to new groups.
The document discusses defining the primary customer for a potential transcription service business. It estimates the market size and potential lifetime value (LTV) per customer. It then discusses how to calculate the cost per acquisition (CPA) and compares it to LTV to determine if advertising can generate a positive return. Key strategies for keeping CPA low like organic search, word-of-mouth, and virality are mentioned. The document emphasizes that comparing LTV to CPA is the key metric for validating business ideas.
This document discusses validating business ideas by testing customer interest using tools like Google AdWords, Facebook Ads, and LinkedIn Ads. It explains how to use these tools to determine if there is a market for your idea by seeing if people are searching for or interested in what you want to offer. Once you have validated there is a market, you can move on to learning more about lifetime customer value versus cost per acquisition. The document provides examples of how to use each tool to test interest in specific target markets or customer profiles.
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Explore the details in our newly released product manual, which showcases NEWNTIDE's advanced heat pump technologies. Delve into our energy-efficient and eco-friendly solutions tailored for diverse global markets.
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Ellen Burstyn: From Detroit Dreamer to Hollywood Legend | CIO Women MagazineCIOWomenMagazine
In this article, we will dive into the extraordinary life of Ellen Burstyn, where the curtains rise on a story that's far more attractive than any script.
Tired of chasing down expiring contracts and drowning in paperwork? Mastering contract management can significantly enhance your business efficiency and productivity. This guide unveils expert secrets to streamline your contract management process. Learn how to save time, minimize risk, and achieve effortless contract management.
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The Most Inspiring Entrepreneurs to Follow in 2024.pdfthesiliconleaders
In a world where the potential of youth innovation remains vastly untouched, there emerges a guiding light in the form of Norm Goldstein, the Founder and CEO of EduNetwork Partners. His dedication to this cause has earned him recognition as a Congressional Leadership Award recipient.
Cover Story - China's Investment Leader - Dr. Alyce SUmsthrill
In World Expo 2010 Shanghai – the most visited Expo in the World History
https://www.britannica.com/event/Expo-Shanghai-2010
China’s official organizer of the Expo, CCPIT (China Council for the Promotion of International Trade https://en.ccpit.org/) has chosen Dr. Alyce Su as the Cover Person with Cover Story, in the Expo’s official magazine distributed throughout the Expo, showcasing China’s New Generation of Leaders to the World.
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50 million companies worldwide leverage WhatsApp as a key marketing channel. You may have considered adding it to your marketing mix, or probably already driving impressive conversions with WhatsApp.
But wait. What happens when you fully integrate your WhatsApp campaigns with HubSpot?
That's exactly what we explored in this session.
We take a look at everything that you need to know in order to deploy effective WhatsApp marketing strategies, and integrate it with your buyer journey in HubSpot. From technical requirements to innovative campaign strategies, to advanced campaign reporting - we discuss all that and more, to leverage WhatsApp for maximum impact. Check out more details about the event here https://events.hubspot.com/events/details/hubspot-new-delhi-presents-unlocking-whatsapp-marketing-with-hubspot-integrating-messaging-into-your-marketing-strategy/
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Prescriptive analytics BA4206 Anna University PPTFreelance
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1. AS SENTCOM PLIANCE
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RoHS II
Technical File Creation
Assent Compliance
Krystal Noseworthy-Baker
phone: 613.882.1429
krystal.baker@assentcompliance.com
C u s t o m s o l u t i o n s f o r c o m p l i a n c e [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
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Introduction to Assent Compliance
Assent Compliance
• Consulting
• Global Requirements
• Compliance Strategies
• Regulatory Interpretations and Impacts
• IT
• Cloud Computing
• Application Design
• Operations
• Program Implementation
• Data Management
C u s t o m s o l u t i o n s f o r c o m p l i a n c y [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
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Agenda
• Requirements
• RoHS recast (RoHS II)
• DoCs
• Technical File
• Due Diligence and Testing
• Technical File Sample
• Enforcement
• Demonstration
• Q&A
C u s t o m s o l u t i o n s f o r c o m p l i a n c y [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
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Requirements
RoHS II Overview
• DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 8 June on the restriction of the use of certain hazardous substances in electrical and electronic
equipment (recast)
• Published in the Official Journal of the European Union: July 2011
• In Effect: July 21, 2011
• Into Member State law: January 2, 2013
• Previous RoHS Directive (2002/95/EC) repealed: January 3, 2013
C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
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Requirements
RoHS II – New products in scope
Category 11
TODAY Medical Devices: In Vitro Diagnostic Devices:
(other) Equipment:
23 May 2012 22 July 2014 22 July 2016
22 July 2019
Consumer Monitoring and Professional Monitoring
Control Instruments: and Control Instruments:
22 July 2014 22 July 2017
C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
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Requirements
RoHS II and the CE Mark
• CE Marking Directive
• DoC, Technical File, CE Mark
»» Declaration of Conformity:
• Decision No 768/2008/EC
• Format in the RoHS recast, Annex VI
»» Technical file:
• Module A of Decision No 768/2008/EC
»» CE Mark:
• Directive 93/68/EEC of 22 July 1993
• Subject to Article 30 of Regulation (EC) No 765/2008.
• Applicable to:
»» Finished products in scope of RoHS recast
»» Placed on the market after January 2, 2013
• For those products already under scope of RoHS
• For the new products under scope, the previous slide provides the dates
C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
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Requirements
RoHS II Responsibilities
Manufacturer Importer
EU Declaration of Conformity EU Declaration of Conformity from manufacturer on record
Technical File Ensure manufacturer has completed the technical file
CE Marking Ensure CE Mark is affixed to the product
Product marking
Ensure manufacturer has completed required product marking
(brand name, serial number, contact information)
C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
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Requirements
Declaration of Conformity
General Requirements:
1. No… (unique identification of the EEE):
2. Name and address of the manufacturer or his authorised representative:
3. This declaration of conformity is issued under the sole responsibility of the manufacturer (or
installer):
4. Object of the declaration (identification of EEE allowing traceability. It may include a photo-
graph, where appropriate):
5. The object of the declaration described above is in conformity with Directive 2011/65/EU of
the European Parliament and of the Council of 8 June 2011 on the restriction of the use of
certain hazardous substances in electrical and electronic equipment (recast)
C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
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6. Where applicable, references to the relevant harmonised standards used or references to the
technical specifications in relation to which conformity is declared:
7. Additional information:
Signature:
• Signed for and on behalf of:
• (place and date of issue):
• (name, function) (signature):
NOTE:
Declaration must be translated into the language or languages required by the Member
State of the market on which the product is placed or made available AND safety in-
structions must be in a language that can be easily understood in every country in the
EU in which the product is sold.
C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
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Requirements
Technical File
• Based on Module A of DECISION No 768/2008/EC
• Has to contain at least the following elements:
• a general description of the product,
• conceptual design and manufacturing drawings and schemes of components,
sub-assemblies, circuits, etc.
• descriptions and explanations necessary for the understanding of those drawings and
schemes and the operation of the product,
• a list of the harmonised standards and/or other relevant technical specifications the
references of which have been published in the Official Journal of the European Union,
applied in full or in part, and descriptions of the solutions adopted to meet the essential
requirements of the legislative instrument where those harmonised
• standards have not been applied. In the event of partly applied harmonised standards,
the technical documentation shall specify the parts which have been applied,
• results of design calculations made, examinations carried out, etc., and
• test reports.
• The documentation shall make it possible to assess the product’s conformity to the relevant
requirements, and shall include an adequate analysis and assessment of the risk
• EN 50581 – Standard for EU Technical Files – In voting stage
C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
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Requirements
Technical File – EN 50581
Technical documentation for the assessment of electrical and electronic products with respect
to the restriction of hazardous substances
• Combination of:
• RoHS Recast (Directive 2011/65/EU)
• Module A of Decision 768/2008
• IEC 62476 – Guidance for evaluation of products with respect to substance-use restric-
tions in electrical and electronic products [Existed Previous to RoHS Recast]
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• Status:
• At voting stage
• Original schedule
»» Official announcement in 6 months from ratification vote
»» In effect in 12 months
• Accelerated schedule [Proposed]
»» Announcement in 3 months from ratification vote
»» In effect in 6 months
• Essentially the items covered under Module A of Decision 768/2008 (previous slide) are covered
in this standard
• More in-depth coverage once the standard is officially released
C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]
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Requirements
Technical File – EN 50581
Beyond EN 50581, it should not be expected that there will be significantly more detail from the
EU Commission. Official statement by the EU Commission regarding RoHS recast:
…as a general rule and in the interests of legal certainty, it is inappropriate for the Commission to
make interpretative statements on legislative texts, which should be comprehensible in themselves.
…note that it is in any event for the Court of Justice alone to provide authoritative interpretations
as to the meaning of Union law.
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Requirements
Technical File – EN 50581
FOUR MAJOR TASKS:
• Determine the information needed
• Collect the information
• Evaluate the information for:
• quality and trustworthiness
• whether to include the documentation in the technical file
• Ensure that the technical documentation remains valid
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Due Diligence and Testing
What is their role in RoHS II Compliance –
specifically the Technical File?
Determination of Necessary Information
• Assess what types of documents are required based on substance presence risk and supplier risk
• Technical judgement allowed
Collection of Information
• Types of allowed documentation
»» Supplier declarations
»» Material Declarations
»» Analytical test results
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Due Diligence and Testing
What is their role in RoHS II Compliance –
specifically the Technical File?
Evaluation of Data
• Mandatory for Manufacturers
• Requirements include:
• Establish procedures for evaluating collected information / documentation
• Evaluate whether each part, component, or material meets the materials restriction re-
quirements of RoHS Recast
• Evaluate whether the document is of sufficient quality to include in the technical
documentation
»» Criteria met = Included
»» Criteria not met = further corrective actions or analysis
Ensuring Validity of Data
• Requirements:
• periodic review of the documents contained in the technical documentation to ensure that
they are still valid;
• technical documentation must reflect any changes to materials, parts or sub-assemblies
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Due Diligence and Testing
What is their role in RoHS II Compliance –
specifically the Technical File?
STANDARD PRACTICE:
• Annual Updates – with the Annual Audit!
• Significant Product Changes = Update File
• Completeness in the Technical File:
• Consumables
• Out of Scope Parts
• Not part of the RoHS Compliance THEREFORE not required to be included
»» Recommended that the out of scope and consumable parts are footnoted
Technical Files – In Practice…
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Due Diligence and Testing – EN 62321
What is their role in RoHS II Compliance –
specifically the Technical File?
Electrotechnical products – Determination of levels of six regulated substances (lead, mercury,
cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated diphenyl
ethers)
• EU Standard for RoHS testing
• Not Mandatory…HOWEVER:
»» Most effective method of risk management
»» Usually less costly than alternative (further/increased) supplier data gathering
and/or corrective action methods
»» Testing to an established standard allows you to quote it in the file = lends credibility
• If you have done it right, others don’t have to!
• Recommended to have at least scan testing to EN 62321:2009 in technical file
»» XRF
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Due Diligence and Testing – EN 62321
Declaration and Test Report Sample Review
Test Report No. : CE/2010/22946 Date : 2010/02/24 Page : 4 of 5
BOURNS TRIMPOT ELECTRONICAS, LIMITADA
DEL CURCE A SAN ANTONIO DE BELEN AUTOPISTA CANAS-150 MTS
*CE/2010/22946* MATERIAL DECLARATION SHEET
AL OESTE HEREDIA, COSTA RICA. Test Report No. : CE/2010/22946 Date : 2010/02/24 Page : 2 of 5
BOURNS TRIMPOT ELECTRONICAS, LIMITADA *CE/2010/22946*
DEL CURCE A SAN ANTONIO DE BELEN AUTOPISTA CANAS-150 MTS
PBB/PBDE analytical FLOW CHART AL OESTE HEREDIA, COSTA RICA.
No. Construction Element Material Group Report Note
1) Name of the person who made measurement: Roman Wong Test results by chemical method (Unit: mg/kg)
2) Name of the person in charge of measurement: Shinjyh Chen Test Item (s):
Method Result
MDL
(Refer to) No.1 1 Element Ink + Ceramic B
First testing process Cadmium (Cd) (1) n.d. 2
Sample
Lead (Pb) (2) 2520 2
Confirmation process
Bourns Trimpot Electronicas, Limitada
Optional screen process
Mercury (Hg) (3) n.d. 2
Hexavalent Chromium Cr(VI) by (4) n.d. 2 2 Back plate 263 Copper alloy A
Del Cruce a San Antonio de Belen
Sample pretreatment alkaline extraction
Sum of PBBs n.d. -
Test Report No. 150 Mts Al Oeste : 2010/02/24
Autopista Cañas - : CE/2010/22946 Date
Monobromobiphenyl of 5
Page : 1
Dibromobiphenyl
n.d.
n.d. 3 5
5
Back plate 220 Copper alloy A
Screen analysis
BOURNS TRIMPOT ELECTRONICAS, LIMITADA Tribromobiphenyl *CE/2010/22946* Heredia, Costa Rica
n.d. 5
DEL CURCE A SAN ANTONIO DE BELEN AUTOPISTA CANAS-150Tetrabromobiphenyl
MTS n.d. 5
Pentabromobiphenyl n.d. 5
AL OESTE HEREDIA, COSTA RICA. Hexabromobiphenyl n.d. 4 5 Wire Copper Alloy A
Sample extraction/ Heptabromobiphenyl n.d. 5
Soxhlet method Octabromobiphenyl n.d. 5
Nonabromobiphenyl
The following sample(s) was/were submitted and identified by/on behalf of the client as :
n.d. No. : CE/2010/22946 Date : 2010/02/24
5 5
5
Mold compound
Page : 3 of 5
Various
Test Report A
Decabromobiphenyl n.d.
(5)
BOURNS TRIMPOT ELECTRONICAS, LIMITADA *CE/2010/22946*
Concentrate/Dilute Sum of PBDEs n.d. -
DEL CURCE A SAN ANTONIO DE BELEN AUTOPISTA CANAS-150 MTS
Sample Description Extracted solution : Monobromodiphenyl ether
BOURNS MODELS PWR263, PWR163, PWR220T, PWR221T AL OESTE HEREDIA,n.d. COSTA RICA.
5
Test Report No. : CE/2010/22946 Date : 2010/02/24
Style/Item No. Page : 5 of 5
:
Dibromodiphenyl ether
THICKFILM POWER RESISTORS/ELEMENT ether
n.d. 5
Tribromodiphenyl n.d. Note A: RoHS compliance.
5
Sample Receiving Date
BOURNS TRIMPOT ELECTRONICAS, LIMITADA : 2010/02/11
Filter *CE/2010/22946* Tetrabromodiphenyl ether n.d. 5
DEL CURCE A SAN ANTONIO DE BELEN AUTOPISTA CANAS-150 MTS
Testing Period : 2010/02/11 TO 2010/02/24 Pentabromodiphenyl ether n.d. Note B: ROHS Compliant By Exemption 5 (lead
1) These samples were dissolved totally by pre-conditioning method according to below flow chart.
5 in glass of
AL OESTE HEREDIA, COSTA RICA.
Hexabromodiphenyl ether (Cr 6+ test method excluded)
n.d. 5
Heptabromodiphenyl ether 2) Name of the person who electronic components)
n.d. made measurement: Climbgreat Yang
5
Analysis by GC/MS
============================================================================================ person in charge of measurement: Troy Chang
Octabromodiphenyl ether 3) Name of the
n.d. 5
Nonabromodiphenyl ether n.d. 5
Decabromodiphenyl ether Cutting / Preparation
n.d. 5
Test Requested :
Issue ReportIn accordance with the RoHS Directive 2002/95/EC, and its amendment
Requirement:
Review points
directives. TEST PART DESCRIPTION:
NO.1 : MIXED ALL PARTS Sample Measurement
Hg Cr6 +
Test Method : Note: 1. mg/kg = ppm; 0.1wt% = 1000ppm
With reference to IEC 62321: 2008 Pb、Cd Contain Pb Hg Cr+6 PBB and PBDE< 0.1 % (1000 ppm) by
2. n.d. = Not Detected
Procedures for the Determination of Levels of=Regulated Substances in
3. MDL Method Detection Limit Acid digestion by suitable acid weight. digestion with
Microwave Add appropriate amount of
Electrotechnical Products.
• Directive Stated
4. "-" = Not Regulated depended on different sample
5. The sample(s) was/were analyzed on behalf of the applicant astable) sample in one testing. /HCl/HF 0.01
material (as below mixing Contain Cd <
HNO3 % (100 ppm) by weight
digestion reagent
(1) Determination of Cadmium by ICP-AES. The above result(s) was/were only given as the informality value.
(2) Determination of Lead by ICP-AES.the results shown in this test report refer only to the sample(s) tested. This test report cannot be reproduced, except in full, without prior written permission of the Company.
Unless otherwise stated
Filtration
(3) Determination of Mercury byReport is issued by the Company under its General Conditions of Service printed overleaf or available on request and accessible at http://www.sgs.com/terms_and_conditions.htm. Attention
This Test ICP-AES.
除非另有說明,此報告結果僅對測試之樣品負責。本報告未經本公司書面許可,不可部分複製。
Heat to appropriate
• Standard Stated
is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this Test Report is advised that information contained hereon reflects the Company’s findings
(4) Determination of Hexavalent Chromium and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction
at the time of its intervention only by UV/Vis Spectrometry.
Unless otherwise stated the results shown in this test report refer only to the sample(s) tested. This test report cannot be reproduced, except in full, without prior written permissionfrom exercising all their rights and obligations under the transaction documents. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and
of the Company.
temperature to extract
Power Resistor RoHS Test
This Test Report is issued by the Company under its General Conditions of Service printed overleaf or available on request and(5) Determination of PBB and PBDE by GC/MS.
除非另有說明,此報告結果僅對測試之樣品負責。本報告未經本公司書面許可,不可部分複製。 offenders may be prosecuted to the fullest extent of the law.
accessible at http://www.sgs.com/terms_and_conditions.htm. Attention Ltd.
SGS Taiwan Residue
** End of Report **
is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this Test Report is advised that information contained hereon reflects the Company’s findings Solution
台灣檢驗科技股份有限公司 Chemical-Taipei 33 WuChyuan Road, Wuku Industrial Zone, Taipei County, Taiwan /台北縣五股工業區五權路33號 t + 886 (02)2299 3279 f + 886 (02)2299 3237 www.sgs.com
at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction
from exercising all their rights and obligations under the transaction documents. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and Member of the SGS Group (SGS SA) Cool, filter digestate
offenders may be prosecuted to the fullest extent of the law. Test Result(s) : Please refer to next page(s).
• Dates
through filter
Report
SGS Taiwan Ltd.
台灣檢驗科技股份有限公司 Chemical-Taipei 33 WuChyuan Road, Wuku Industrial Zone, Taipei County, Taiwan /台北縣五股工業區五權路33號 t + 886 (02)2299 3279 f + 886 (02)2299 3237 www.sgs.com 1) Alkali Fusion
Member of the SGS Group (SGS SA) 2) HCl to dissolve
Add diphenyl-carbazide for
ICP-AES
color development
Sample Material
Steel, copper, aluminum, solder
Glass
Digestion Acid
Aqua regia, HNO3 , HCl, HF, H 2O2
HNO3 /HF
• Signature measure the absorbance
at 540 nm by UV-VIS
MODEL: PWR263S Gold, platinum, palladium, ceramic
Silver
Aqua regia
HNO3
• This lab is fairly well known
Plastic H2 SO4 , H2O2 , HNO 3, HCl
Others Any acid to total digestion
Unless otherwise stated the results shown in this test report refer only to the sample(s) tested. This test report cannot be reproduced, except in full, without prior written permission of the Company.
除非另有說明,此報告結果僅對測試之樣品負責。本報告未經本公司書面許可,不可部分複製。
This Test Report is issued by the Company under its General Conditions of Service printed overleaf or available on request and accessible at http://www.sgs.com/terms_and_conditions.htm. Attention
is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this Test Report is advised that information contained hereon reflects the Company’s findings
at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction
• Product Identification is very clear
Unless otherwise stated the results shown in this test report refer only to the sample(s) tested. This test report cannot be reproduced, except in full, without prior written permission of the Company.
from exercising all their rights and obligations under the transaction documents. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and 除非另有說明,此報告結果僅對測試之樣品負責。本報告未經本公司書面許可,不可部分複製。
offenders may be prosecuted to the fullest extent of the law. This Test Report is issued by the Company under its General Conditions of Service printed overleaf or available on request and accessible at http://www.sgs.com/terms_and_conditions.htm. Attention
SGS Taiwan Ltd. is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this Test Report is advised that information contained hereon reflects the Company’s findings
Unless otherwise stated the results shown in this test report refer only to the sample(s) tested. This test report cannot be reproduced, except in full, without prior written permissionthe time Company.
at
of the of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction
台灣檢驗科技股份有限公司 Chemical-Taipei 33 WuChyuan Road, Wuku Industrial Zone, Taipei County, Taiwan /台北縣五股工業區五權路33號 t + 886 (02)2299 3279 f + 886 (02)2299 3237 www.sgs.com
除非另有說明,此報告結果僅對測試之樣品負責。本報告未經本公司書面許可,不可部分複製。 from exercising all their rights and obligations under the transaction documents. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and
This Test Report is issued by the Company under its General Conditions of of the SGS Group (SGSoverleaf or available on request and accessible at http://www.sgs.com/terms_and_conditions.htm. Attention
Member Service printed SA) offenders may be prosecuted to the fullest extent of the law.
is drawn to the limitation of liability, indemnification and jurisdiction issues defined therein. Any holder of this Test Report is advised that information contained hereon reflects the Company’s findingsLtd.
SGS Taiwan
at the time of its intervention only and within the limits of Client’s instructions, if any. The Company’s sole responsibility is to its Client and this document does not exonerate parties to a transaction
台灣檢驗科技股份有限公司 Chemical-Taipei 33 WuChyuan Road, Wuku Industrial Zone, Taipei County, Taiwan /台北縣五股工業區五權路33號 t + 886 (02)2299 3279 f + 886 (02)2299 3237 www.sgs.com
from exercising all their rights and obligations under the transaction documents. Any unauthorized alteration, forgery or falsification of the content or appearance of this document is unlawful and
offenders may be prosecuted to the fullest extent of the law. Member of the SGS Group (SGS SA)
SGS Taiwan Ltd.
台灣檢驗科技股份有限公司 Chemical-Taipei 33 WuChyuan Road, Wuku Industrial Zone, Taipei County, Taiwan /台北縣五股工業區五權路33號 t + 886 (02)2299 3279 f + 886 (02)2299 3237 www.sgs.com
Member of the SGS Group (SGS SA)
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Due Diligence and Testing – EN 62321
Declaration and Test Report Sample Review
456 Seastrom St. Twin Falls, ID 83301
October 13, 2011 Certificate of Compliance
European Union Directive 2002/95/EC
Restriction of Hazardous Substances
Any Seastrom part number, produced by Seastrom Manufacturing Co., Inc. that meets the following
conditions is classified as compliant in accordance with European Union Directive 2002/95/EC (RoHS).
Material:
456 Seastrom St. Twin Falls, ID 83301
Any of the materials listed below without a process/finish.
October 13, 2011
Non-Metals:
Delrin (Acetal) Non-Compliance
Certificate of Mica Polyethylene
Epoxy Glass Mylar PVC (Polyvinyl Chloride)
(Fiberglass) Neoprene
European Union Directive 2002/95/EC Santoprene
FluorocarbonHazardous Substances
Restriction of (Viton) Nitrile (Buna-N) Silicone
Fluorosilicone Nylatron Teflon
The following materials and processes used at Seastrom Manufacturing Co., Inc. have
Kapton Nylon
been classified as Non-Compliant in accordance with the European Union Directive Vulcanized Fibre
KEL-F (PCTFE)
2002/95/EC (RoHS). This Directive, however, does not Phenolic affect the use of parts in
Metals:
applications outside of the Directive’s specified countries.
Review points
Brass Phosphorus Bronze Stainless Steel
Non-Compliant Process/Finish
Copper Cold Rolled Steel Steel
Beryllium Copper Spring Steel Titanium
Process/Finish: Denoted @ end of part # as:
• Directive Stated
Chemical Film Finish The following base materials contain > 0.1% lead, but are exempt under note 6 of the Directive’s
Annex:
-CF
Hexavalent Chromium Finish -CHR
12L14 Steel (0.35% -C1,weight max)
of -C2 C - 360 Brass Rod (3.7% of weight max)
• Note that this is in accordance with the “original” RoHS and not the recast however
Cadmium
Chrome -CHR
Process/Finish:
60/40 Tin Lead Finish -TL1, -TL2
Any Seastrom part number-Z2
Zinc Plate, Type II (Yellow)
you will also note that most of the important elements are included
produced with a process/finish listed below is compliant under the
Chromatic Anodize, Directive, unless the base material is Aluminum. (Contact Seastrom for Aluminum part status)
Type I -A1
Standard Electroless Nickel Plating (can be RoHS compliant if specified by customer on
Compliant Process/Finish: Denoted @ end of
order) part # as:
Less Finish -LF
• Regulatory wording may be slightly different but the declaration speaks to it!
Non-Compliant Materials:
Sulfuric Anodize, Type II -A2
2011 Aluminum Rod (primarily used in shoulder washers, spacers, and washers with
Black Oxide a specified part.
to see if Aluminum 2011 is used for
• Highlights non-compliant and compliant parts/processes/finishes
thin side walls.) For Aluminum parts, please contact Seastrom at info@seastrom-mfg.com -A3
Hard Anodize, Type III
-BO
Passivate -P
Sincerely, Phosphate
Electrolytic Nickel Plate • Includes part # denotations
-PH
-N
Silver Plate -S
Maegan Melton
Quality Engineer
Tin Plate
Tin Dip
Brad Mohr
• Exemptions (as applicable)
Process Engineer
-T1
-T2
Zinc Plate, Type I (Blue) -Z1
• Dated
Seastrom Manufacturing Co., Inc. is Certified ISO 9001:2000 and AS9100:2004
Zinc Plate, Type III (Clear) -Z3
Designated Electroless Nickel Plate (RoHS Compliance must be requested by customer)
Sincerely,
• Signature and Function
Maegan Melton Brad Mohr
Quality Engineer • Letterhead
Process Engineer
• Contact for further information
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Due Diligence and Testing – EN 62321
Declaration and Test Report Sample Review
1630 McCarthy Boulevard
Milpitas, CA 95035-7417
RoHS DIRECTIVE 2011/65/EU MATERIAL
DECLARATION CERTIFICATE
Linear Technology Corporation certifies the deliverable products, when ordered as lead-free meet the RoHS DIRECTIVE
Review points
2011/65/EU.
• Restriction of the use of certain hazardous substances in electrical and electronic equipment (Recast) does not pertain to
• Directive Stated
Linear Technology Corporation.
• Linear Technology Corporation also complies with: People’s Republic of China RoHS Directive EIS SJ/T11364-2006 • RoHS recast
RoHS Definitions:
• Concentration limit of 0.1% by mass (1000 PPM) in homogeneous material for Lead (Pb), Mercury (Hg),
Hexavalent Chromium (Cr), Polybrominated Biphenyl (PBB), Polybrominated Diphenyl Ether (PBDE),
»» Does not include the specific regulatory wording
Decabromodiphenyl Ether (Deca-BDE), Toluene, Trichlorobenzene, and Hexabromocyclododecane (HBCDD),
Bis (2-ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP), Dibutylphthalate (DBP) (as indicated in the earlier slide)
• Concentration limit of 0.01% by mass (100 PPM) of homogeneous material for Cadmium (Cd)
• Concentration limit of 0.005% by mass (50 PPM) for Perfluorooctane Sulfonates (PFOS)
RoHS Exemption:
• Confusing wording
• Products in the TO-220, DDPAK, SOT223 and TO247 packages are currently assembled with a Soft Solder Die Attach material
containing Lead (Pb). Article 4, Annex 7a (>85% Lead, Pb, in high melting point solders) exempts this material at this time. • Certifies that it meets the directive HOWEVER
The Chinese RoHS EFUP Logo 2 applies when these packages are shipped to the People’s Republic of China.
• The micro modules products contain lead in the glass frit. Article 4, Annex 7(c)-1, (electronic components containing lead in a
glass or ceramic other than dielectric ceramic in capacitors, e.g. piezoelectronic devices, or in a glass or ceramic matrix compound.
»» Restriction of the use of certain hazardous substances in
The Chinese RoHS EFUP Logo 2 applies when these packages are shipped to the People’s Republic of China.
Substances of Concern:
electrical and electronic equipment (Recast) does not pertain to
• Antimony Trioxide, Sb2O3 (CAS# 1309-64-4) and Bromine, Br (CAS# 10097-32-2) are used as a flame retardant in mold
compound in several products. Linear Technology Corporation is evaluating and qualifying new mold compounds that contain Linear Technology Corporation.
no Sb2O3, or Br. Once qualified these products will be considered Halogen-Free.
• Polyvinyl Chloride (PVC) – in shipping tubes, CAS #9002-86-2. The tubes are reused 2 times then recycled.
• Linear Technology Corporation products do not contain or have termination finishes of Pure Lead or Pure Zinc. • Exemptions (as applicable)
Linear Technology Corporation’s Device Material Declaration concentrations are estimated and are derived from engineering
calculations.
Linear Technology Corporation has a lifetime warranty on all our products, with Linear Technology Corporation standard liability
• Dated
limited to the replacement of confirmed defective products. Linear Technology Corporation’s ongoing Environmental Program will
help ensure we are in compliance with our customer’s environmental needs.
• Signature and Function
_____________________________________________________
Paul Chantalat
• Letterhead
Vice President, Quality and Reliability
LINEAR TECHNOLOGY CORPORATION ACCEPTS NO DUTY TO NOTIFY USERS OF THIS DECLARATION OF
UPDATES OR CHANGES TO THIS DECLARATION.
• Contact for further information
LTC Revision 7 February 3, 2012
CONTACT INFORMATION:
Name: Bobbi Bennett Title: QA Specification Review Manager and Product Environmental Specialist Email: bdbennett@linear.com • The final statement does not provide confidence in the long-term compliance
Linear Technology Corporation, 1630 McCarthy Blvd, Milpitas, CA 95035-7417, 408-432-1900
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Due Diligence and Testing – EN 62321
Declaration and Test Report Sample Review
Review points
• Directive Stated
• Note that this is in accordance with the “original” RoHS
• Exemption is simply stated as exception with no detail
• Dated
• No Signature or Function
• Letterhead
• Contact for further information
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Enforcement
• Declaration of Conformity
• Easy diagnosis of compliance
• Technical File
• Member State Enforcement Agency’s – first line of defense
• RoHS material restrictions are MUCH easier and less destructive to test for than REACH
• Be AWARE
• Fines – member state by member state
• Stuck at Customs
• Rejected at Customs
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Questions?
Please submit your questions in writing using the Q&A tool along the top menu tool bar.
Any questions not addressed during the Q&A portion of this webinar will be addressed in private
correspondence after the webinar.
C u s t o m s o l u t i o n s f o r c o m p l i a n c E [ REAC H | R o H S | CP s i a | RSL | p r o p 6 5 ]