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
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
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. The standard focuses on meeting customer and applicable regulatory requirements and is intended for any organization partially or fully involved in the medical device life-cycle.
This presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 13485:2016 standard. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors in the medical devices industry.
It covers the what and why of ISO 13485, the QMS key clause structure, the audit approach and also offers practical tips on how to handle an audit session. When you are done teaching this material to your employees, they will be much more informed and comfortable with ISO 13485:2016.
LEARNING OBJECTIVES
1. Provide background knowledge on ISO 13485:2016
2. Gain an overview of ISO 13485:2016 structure and the certification process
3. Understand the audit approach
4. Gather useful tips on handling an audit session
CONTENTS
1. Overview of ISO 13485
About ISO
What are Standards?
Why are Standards Important?
What is ISO 13485?
Who is ISO 13485 For?
What is a Medical Device?
What is a Quality Management System?
How Does ISO 13485 Work?
Benefits that ISO 13485 Will Bring to the Organization
Advantages of Certification
Development of ISO 13485
Why Was ISO 13485 Revised?
Key Improvements to ISO 13485:2016
Relationship of ISO 13485 with ISO 9001
2. ISO 13485:2016 Structure
The ISO 13485:2016 Structure
The Plan-Do-Check-Act (PDCA) Process Model
ISO 13485:2016 Approach is Based on the PDCA Cycle
Documentation Requirements
ISO 13485:2016 Key Clause Structure (4-8)
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis & Improvement
3. ISO 13485:2016 Certification
Becoming ISO 13485:2016 Certified
ISO 13485:2016 Certification Process
4. Audit Approach
What is a Quality Audit?
What Are Audits Used For?
Types of Quality Audits
Internal Quality Audit
Principles of Auditing
Audit Focus
Audit Approach
Audit Emphasis
Document Review
Audit Findings
5. Handling an Audit Session
Rights of Auditee
Rights of Auditor
How to Handle an Audit Session?
Auditee's Conduct
Interacting with Auditors: Do's
Interacting with Auditors: Don'ts
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
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
[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
ISO 13485:2016 is an international standard that sets out the requirements for a quality management system (QMS) specific to the medical devices industry. The standard focuses on meeting customer and applicable regulatory requirements and is intended for any organization partially or fully involved in the medical device life-cycle.
This presentation can be used to brief your employees, new hires and potential auditees so as to create awareness of the ISO 13485:2016 standard. Alternatively, the presentation may be used to supplement your materials for the training of QA professionals and internal auditors in the medical devices industry.
It covers the what and why of ISO 13485, the QMS key clause structure, the audit approach and also offers practical tips on how to handle an audit session. When you are done teaching this material to your employees, they will be much more informed and comfortable with ISO 13485:2016.
LEARNING OBJECTIVES
1. Provide background knowledge on ISO 13485:2016
2. Gain an overview of ISO 13485:2016 structure and the certification process
3. Understand the audit approach
4. Gather useful tips on handling an audit session
CONTENTS
1. Overview of ISO 13485
About ISO
What are Standards?
Why are Standards Important?
What is ISO 13485?
Who is ISO 13485 For?
What is a Medical Device?
What is a Quality Management System?
How Does ISO 13485 Work?
Benefits that ISO 13485 Will Bring to the Organization
Advantages of Certification
Development of ISO 13485
Why Was ISO 13485 Revised?
Key Improvements to ISO 13485:2016
Relationship of ISO 13485 with ISO 9001
2. ISO 13485:2016 Structure
The ISO 13485:2016 Structure
The Plan-Do-Check-Act (PDCA) Process Model
ISO 13485:2016 Approach is Based on the PDCA Cycle
Documentation Requirements
ISO 13485:2016 Key Clause Structure (4-8)
Clause 4: Quality Management System
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis & Improvement
3. ISO 13485:2016 Certification
Becoming ISO 13485:2016 Certified
ISO 13485:2016 Certification Process
4. Audit Approach
What is a Quality Audit?
What Are Audits Used For?
Types of Quality Audits
Internal Quality Audit
Principles of Auditing
Audit Focus
Audit Approach
Audit Emphasis
Document Review
Audit Findings
5. Handling an Audit Session
Rights of Auditee
Rights of Auditor
How to Handle an Audit Session?
Auditee's Conduct
Interacting with Auditors: Do's
Interacting with Auditors: Don'ts
In your daily life, while using and handling items such as mobile phones, music players, toys, cables, and other
electronic equipment or machines, you might have noticed two letters, CE, on these products. Forasmuch as
this is a mark applicable to products traded within the European Economic Area (EEA, the 27 Member States
of the European Union [EU] and 3 countries of the European Free Trade Association [EFTA]: Norway, Iceland
and Liechtenstein), consumers living in these areas may be familiar with it as it can be found in almost every
product. But yet many people may wonder why it is applied to products or what does it serve for.
CE Marking is the symbol as shown on the top of this page. The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity". The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. "CE Marking" is now used in all EU official documents.
"CE Mark" is also in use, but it is NOT the official term. For instance, in the Directive 2007/47/ec, of 5 September 2007, amending the directives 90/385/eec, 93/42/eec & 98/8/ec, the term CE Marking appears 9 times whereas CE Mark appears nowhere in the entire 35-page document.
CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives.*
Risk Management for Medical Devices - ISO 14971 Overview Greenlight Guru
Risk Management for Medical Devices. An overview of ISO 14971 & how to apply a "Risk-based Approach" to your QMS processes to address the upcoming changes to ISO 13485.
The UDI system was created, developed and maintained by the device manufacturer based on global device identification standards. Today, it also helps with procurement and reimbursement. The Regulations allow for random inspections of producers’ facilities after devices have been placed on the market.
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
Explanation of ISO standard 13485 (QUALITY MANAGEMENT SYSTEM OF MEDICAL DEVICES) in a clarified way to understand it well in a simplified way through this mode. Your comments are appreciated.
Sample ISO 13485 Quality Manual & Procedures Package ComplianceOnline
This procedure describes Management Responsibilities for the Quality Management System (QMS) at Your Company.
For more Information please visit and copy paste in browser.
http://www.complianceonline.com/iso-13485-quality-manual-procedures-package-standards-10218-prdp
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.
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.
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.
Webinar: The Radio Equipment Directive and European StandardstechUK
Slides from Webinar "The Radio Equipment Directive and European Standards –Time running out to comply" held on 22nd April by techUK Future Technologies Network, Communications Policy Council and ETSI
The presentation provide a simple and clear explanation to all aspects of ISO : 14001 Environmental Management System for a manufacturing organization with thrust for line managers.
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.
In your daily life, while using and handling items such as mobile phones, music players, toys, cables, and other
electronic equipment or machines, you might have noticed two letters, CE, on these products. Forasmuch as
this is a mark applicable to products traded within the European Economic Area (EEA, the 27 Member States
of the European Union [EU] and 3 countries of the European Free Trade Association [EFTA]: Norway, Iceland
and Liechtenstein), consumers living in these areas may be familiar with it as it can be found in almost every
product. But yet many people may wonder why it is applied to products or what does it serve for.
CE Marking is the symbol as shown on the top of this page. The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity". The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. "CE Marking" is now used in all EU official documents.
"CE Mark" is also in use, but it is NOT the official term. For instance, in the Directive 2007/47/ec, of 5 September 2007, amending the directives 90/385/eec, 93/42/eec & 98/8/ec, the term CE Marking appears 9 times whereas CE Mark appears nowhere in the entire 35-page document.
CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives.*
Risk Management for Medical Devices - ISO 14971 Overview Greenlight Guru
Risk Management for Medical Devices. An overview of ISO 14971 & how to apply a "Risk-based Approach" to your QMS processes to address the upcoming changes to ISO 13485.
The UDI system was created, developed and maintained by the device manufacturer based on global device identification standards. Today, it also helps with procurement and reimbursement. The Regulations allow for random inspections of producers’ facilities after devices have been placed on the market.
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
Explanation of ISO standard 13485 (QUALITY MANAGEMENT SYSTEM OF MEDICAL DEVICES) in a clarified way to understand it well in a simplified way through this mode. Your comments are appreciated.
Sample ISO 13485 Quality Manual & Procedures Package ComplianceOnline
This procedure describes Management Responsibilities for the Quality Management System (QMS) at Your Company.
For more Information please visit and copy paste in browser.
http://www.complianceonline.com/iso-13485-quality-manual-procedures-package-standards-10218-prdp
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.
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.
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.
Webinar: The Radio Equipment Directive and European StandardstechUK
Slides from Webinar "The Radio Equipment Directive and European Standards –Time running out to comply" held on 22nd April by techUK Future Technologies Network, Communications Policy Council and ETSI
The presentation provide a simple and clear explanation to all aspects of ISO : 14001 Environmental Management System for a manufacturing organization with thrust for line managers.
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.
RoHS, REACH, and Other Environmental Requirements Enviropass
This presentation delves into critical environmental regulations and requirements, focusing on the European Union's RoHS and REACH directives. It outlines the fundamental aspects of the RoHS directive, including its scope, basic rules, exemptions, technical documentation, and the CE mark.
RoHS
The gist of the European Union (EU) RoHS Directive:
https://www.getenviropass.com/europe-rohs/
- The scope
- Basic rules
- Exemptions list
- Technical documentation
- CE mark
Countries with RoHS regulations outside of the EU
EU REACH
What is it? How does REACH apply to articles?
https://www.youtube.com/watch?v=KnnoY4Byt8s&t=2s
• Article 33
• Substances of Very High Concern - SVHC
• The once an article, always an article principle
• The SCIP database and notification process (https://echa.europa.eu/scip)
• Annex XVII
Other Product Environmental Requirements
They include:
• Substance restrictions in products.
• Obligations to declare substance above certain thresholds.
• Declarations of products places into a specific market and Waste of Electrical and Electronic Equiment (WEEE)
• Energy efficiency.
• Conflict Mineralsè.
• Standards like ISO 14001 and IEC QC 080000
How to Comply with Substances Control
This section compares:
• analytical testing, such as the X-Ray Fluorescence (XRF) method for the detection of heavy metals; and
• documentary review, following standard IEC 63000
The presentation has been meticulously prepared by Aury Hathout from Enviropass, a leading expert in environmental compliance. For more information, visit: https://www.getenviropass.com/contact/
Quý khách có nhu cầu mua hàng hoặc hợp tác cùng chúng tôi xin vui lòng liên hệ theo địa chỉ :
CÔNG TY CỔ PHẦN HẠO PHƯƠNG
Trụ sở chính:
Địa chỉ: Số 88 đường Vĩnh Phú 40, Kp. Hòa Long, P. Vĩnh Phú, Thuận An, Bình Dương.
Văn phòng Hà Nội:
Địa chỉ: Số 95 TT4 – KĐT Mỹ Đình Sông Đà – Phường Mỹ Đình – Q. Nam Từ Liêm – Hà Nội
Chi nhánh Cambodia:
Địa chỉ: The Park Land SenSok, Borey Chip Mong, House Number 22, P11.Sangkat Phnom Penh Thmey, Khan San Sok, Phnom Penh.
Email: cs@haophuong.com – Website: haophuong.com
Facebook: https://www.facebook.com/haophuongcompany/
HOTLINE: 1800 6547
Bảng giá máy cắt không khí ACB Easypact EVS schneider
Long Nguyễn đại lý phân phối máy cắt không khí Schneider tại Việt Nam
http://longnguyenvn.com/category/acb-evs-schneider
Accredited testing laboratory according to the harmonized standards for areas: EMC, radio equipment, low voltage directive, environmental testing, gas appliances directive and IP & IK testing.
Emergi lite emergency lighting design guideEmergi-Lite
The Emergi-Lite delivers highly versatile emergency lighting solutions to a wide range of industries, with the
protection and safety of human life paramount.
Emergency lighting is a vital and effective life safety tool, providing reassurance and guidance to people at critical times when they need to escape quickly and safely from a building.
Intended for: Safety officers, building designers, specifiers, consultants, employers, facilities managers and any responsible person needing to help people evacuate a building safely, quickly, without stumbling and without panic.
Similar to Guide for the implementation of the RoHS Directive by manufacturers of electrical equipment (20)
Le Gimélec, accélérateur des transition énergétique et numérique
À l’occasion des élections présidentielles et législatives de mai et juin 2017, le Gimélec a souhaité rappeler dans son rapport d’activité les propositions de valeur des entreprises qu’il fédère.
Au croisement des technologies de l’électricité, de l’automatisation et du numérique, et présentes dans tous les secteurs de l’économie, nos entreprises sont porteuses de solutions essentielles pour accélérer les transitions énergétique et numérique et faire en sorte que la France en recueille tous les fruits :
• Les technologies de l’industrie du futur, grâce au numérique, permettent à nos PME industrielles de gagner en compétitivité.
• Les systèmes électriques intelligents facilitent l’intégration des énergies renouvelables, favorisent la maîtrise de la demande d’énergie et la flexibilité, limitent le recours à des sources de production carbonées et optimisent les investissements dans les réseaux.
• Les bâtiments, désormais connectés, réduisent leur empreinte environnementale, offrent de nouveaux services à leurs occupants et deviennent un élément de flexibilité du système énergétique.
• Les data centers, infrastructures essentielles à la performance et à la disponibilité des services numériques, se déploient sur l’ensemble du territoire national pour assurer le développement de l’économie numérique tout en maîtrisant leurs consommations d’énergie et de ressources.
• Le véhicule électrique associé à des solutions de recharge intelligente révolutionne la mobilité en réduisant drastiquement nos émissions de CO2 tout en permettant d’auto-consommer une production locale d’énergie renouvelable.
Start-ups et PMI : au cœur de la décarbonation du système énergétique dans le...Gimélec
Récupération de chaleur industrielle, gestion intelligente de l'éclairage public, climatisation solaire réversible, panneaux solaires hybrides produisant électricité et eau chaude sanitaire, centrales solaires à concentration, valorisation des déchets organiques par méthanisation : startups et PME industrielles proposent de nombreuses solutions innovantes pour une industrie, des bâtiments et des transports moins émetteurs de gaz à effet de serre. Compétitives et créatrices d’emplois locaux, ces solutions participent à la mise en œuvre d’une stratégie énergétique à l’échelle locale.
Le collectif France Green Industries organisait le 7 décembre 2015, dans le cadre de la COP21 (Espaces Générations Climat), une conférence-débat consacrée au rôle central des startups et des PMI dans la décarbonation du système énergétique dans les territoires.
Systèmes d'Information Energétique (SIE) : Engager une démarche d'efficacité ...Gimélec
A l’occasion d’Interclima+Elec, présentation des avantages des SIE en termes de :
- réduction et contrôle des dépenses de fonctionnement,
- réalisation de rapports sur la performance énergétique d'un bâtiment,
- validation du retour sur investissement des projets d'efficacité énergétique.
Concevoir et exploiter des BEPOS flexibles et connectés au réseau Gimélec
A l'occasion d'Interclima+Elec, intervention sur les bénéfices des bâtiments à énergie positive (BEPOS) - éléments de flexibilité du système électrique, réponse à la variabilité des EnR - et le rôle de la gestion active pour l'optimisation dynamique des consommations énergétiques.
Efficacité des ressources des Data Centers : 10 ans de travail collaboratifGimélec
A l'occasion d'Interclima+Elec, intervention des constructeurs sur les actions entreprises au cours des 10 dernières années pour améliorer l'efficacité des ressources des data centers et présentation des futurs enjeux.
Les solutions de collecte et traitement disponibles pour les DEEE du bâtimentGimélec
A l'occasion d'Interclima+Elec, interventions des entreprises sur leur démarche collective et de l'éco-organisme Récyclum sur les solutions mises en place et l'expérience Démoclès.
Data Center Resource Efficiency : a 10-year collaborative effortGimélec
Les Data Centers sont généralement considérés comme d’importants consommateurs de ressources, d’énergie en particulier. Cependant, pour répondre à la forte croissance du trafic de données, l’industrie des Data Centers s’est mobilisée très tôt, aux côtés des organismes de normalisation et des administrations, pour améliorer l’efficacité des Data Centers dans l’utilisation des ressources. Cette courte publication du Comité de marché Data Centers fait le point sur dix ans de travail des équipementiers en faveur de l’efficacité énergétique des Data Centers, exemples à l’appui.
Présentation du Guide Gimélec de reporting RSE au Colloque "La RSE en Actes" ...Gimélec
La Plateforme RSE, rattachée à France Stratégie, et le Conseil économique, social et environnemental (CESE) a organisé le 17 novembre de 8h00 à 18h30 un colloque intitulé « La RSE en actes ». Cet événement a permis un échange autour des propositions formulées par les institutions sollicitées par le gouvernement sur la RSE et de débattre de ce que devrait être un Plan National d’Action ambitieux en matière de RSE.
Le Gimélec est intervenu pour présenter son Guide sectoriel de reporting RSE, publié en 2014 dans le but d’aider toutes les entreprises qui veulent construire leur reporting RSE en conformité avec la loi Grenelle 2. Les membres de Gimélec sont fortement engagés dans une réflexion sur le développement durable et la responsabilité sociétale, notamment au travers de leur Commission développement durable.
Systèmes d'information énergétique : Recommandations pour les décideursGimélec
Contexte réglementaire (fin des tarifs réglementés de vente, obligation d’audit énergétique…) et hausse des factures énergétiques incitent les entreprises et les collectivités à maîtriser les consommations de leur parc immobilier. Afin d’accompagner les décideurs dans cette démarche, le Gimélec publie un recueil de recommandations pour la mise en œuvre de systèmes d’information énergétique (SIE). En décrivant les fonctions et principaux bénéfices apportés par les SIE, ce document montre que leur mise en œuvre est partie intégrante de toute démarche d’efficacité énergétique dans les bâtiments.
Ce rapport offre un condensé des actions menées en 2013 par le Gimélec sur les marchés de l’Energie, du Bâtiment, de l’Industrie et de la Distribution basse tension. Il présente également les activités transverses de notre Groupement : adaptation de l’offre de formation à la numérisation de l’énergie, consolidation de notre présence dans les organismes de normalisation, mobilisation en faveur d’évolutions législatives porteuses d’une politique d’efficacité énergétique volontariste, notamment.
Gimélec : des industriels au service de l’intelligence énergétiqueGimélec
Le Gimélec fédère 200 entreprises qui fournissent des solutions électriques et d’automatismes sur les marchés de l’énergie, du bâtiment, de l’industrie, des Data Centers et des infrastructures.
Deciding where to locate your future Datacenter is the first strategic decision for any company seeking to optimize the value of its investment and secure its asset on a long term basis.
This is a strategic equation that needs a careful due diligence process to assess critical factors. Among them are political stability, security, competitive and growing market, international laws and compliance, and many other key benefits such as cost, engineering capabilities, availability and quality of power, fibre connectivity, tax incentives...
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Guide for the implementation of the RoHS Directive by manufacturers of electrical equipment
1. FOR THE IMPLEMENTATION
OF THE RoHS DIRECTIVE
BY MANUFACTURERS OF ELECTRICAL EQUIPMENT
Prepared by FIEEC (DOMERGIE and GIMELEC sectors)
with the contribution of ZVEI, GAMBICA, ANIE, AGORIA.
This guide will be updated next month, in order
to integrate the harmonised vision of the European industry.
This one is being discussed within ORGALIME.
GUIDE
2. 1CONTENTS OF THE DIRECTIVE
AND SCOPE OF APPLICATION
1.1 Purpose of the Directive
1.2 Scope
1.3 Terms and definitions
1.4 Remanufactured equipment
1.5 Exemptions
WHAT INFORMATION
NEEDS TO BE PROVIDED
TO THE CUSTOMER?
2.1 Products falling within the scope of the RoHS Directive
2.2 Products falling outside of the scope of RoHS Directive
2
2
3. FOREWORD
Any product, including goods and services, carries with it an impact on the environment.
This impact may be manifested at any stage of the life cycle of the product, and can be assessed
by certain indicators. This assessment must be based on multiple criteria if it is to avoid pollution
transfer, and must consider natural resource depletion, energy consumption, air emission,
the discharge of waste into water, etc.
For this reason, manufacturers of electrical equipment are currently promoting a global
environmental approach, taking into account a whole range of environmental criteria.
In this general context of environmental concern, which aims to prevent risks to human
health and the environment, public authorities in particular have decided to restrict the use
of certain substances in Electrical and Electronic Equipment (EEE).
Directive 2002/95/EC (known as the “RoHS1
Directive”) limits the use of lead, cadmium,
mercury, hexavalent chromium polybrominated biphenyls and polybrominated diphenylethers
in the manufacture of specified items of equipment as from 1 July 2006.
The purpose of this guide is to explain the content of Directive 2002/95/EC and
to define its effect on sectors of electrical equipment manufacturing, from electrical
installation devices to automation systems to medium-and high-voltage equipment.
This guide presents a European vision shared by the electrical industry in the UK, Italy,
France and Germany. This document is for informational purposes only and has no legal standing.
It should not be substituted for professional legal advice.
Most electrical installation devices, automation systems, and medium-and high-voltage
equipment are outside the scope of the RoHS Directive. Nevertheless, this guide provides
guidelines to help manufacturers hold intensive "environmental" dialogues with their suppliers
and customers, and to meet their customers increasing demands that relate to compliance
with Directive 2002/95/EC (even if they are not in the scope).
ANY PRODUCT, INCLUDING GOODS AND SERVICES,
CARRIES WITH IT AN IMPACT ON THE ENVIRONMENT.
3
1 "Restriction of Hazardous Substances"
4. CONTENTS
OF THE DIRECTIVE
AND SCOPE
OF APPLICATION
1
PURPOSE OF THE DIRECTIVE
As of 1 July 2006, Directive 2002/95/EC on
the Restriction of Hazardous Substances (RoHS)
restricts the use of lead, cadmium, hexavalent
chromium, mercury and brominated flame
retardants in some types of electrical and
electronic equipment placed on the market within
the European Union.
The RoHS Directive is based on Article 95 of the EC
Treaty and Member States shall not adopt stricter
measures.
1.1
1.2 SCOPE
The RoHS Directive applies to certain types of
electrical and electronic equipment that are
"put on the market" (see 1.3) after 1 July 2006.
Manufacturers of components, sub-assemblies, and
spare parts for such equipment are also affected.
In order to address some of the questions relating
to the scope of the RoHS Directive, the French
industry has developed a decision tree that
identifies the various criteria for determining
whether specificequipment falls under the scope
of the RoHS Directive.
The European industry is defining a common
decision tree, validated by all the European
countries. The present decision tree will be updated
in the next month in order to integrate
the conclusions of European discussions.
The Directive relates to Electric and Electronic
Equipment (EEE) that are "put on the market"
as finished products with a direct function.
However, as the directive addresses material
contents, restriction of material use in a given
finished product indirectly might imply the same
requirements to all of its parts (material,
components, sub-assemblies) apart from
exempted applications that are listed in the
annex to the directive itself.
Single components or parts of finished
products are not in the scope of the RoHS Directive
and do not need to meet any RoHS compliance
requirements.
As a result, table 1 lists examples of products
that are not affected by the RoHS Directive.
Actually, only a limited number of product types
covered by our industry sector fall explicitly
within the scope of the directive (see annex 1A
of the Directive), including:
4
5. 2 Note: In contrast to large-scale stationary industrial tools, small and mobile electrical tools (e.g.; electrical screw drivers) are in the scope
of the directive. In practice, they can be defined as electrical equipment which meet the following criteria :
. they are finished product with a direct function
. they are placed on the market as a single functional or commercial unit
. they can be used in any place without specific installation/erection needs. In practice, they shall be fitted with a standard plug
that can be connected directly to any standard socket.
3 See the decision tree overleaf.
• Large household appliances
• Small household appliances
• IT and telecommunications equipment
• Consumer equipment
• Lighting equipment
• Electrical and electronics tools,
with the exception of large-scale stationary
industrial tools2
• Toys, sports and leisure equipment
• Automatic dispensers
EXAMPLE OF EXCLUDED PRODUCTS
EXAMPLES OF PRODUCTS
NOT AFFECTED,
unless they are part of product covered
by the directive3
Insulators, trunking and cable trays,
generating sets...
• Switchgear and controlgear
• Distribution Boards and
Motor Control Centres
• Circuit-breakers
• Fuses
• Protection relays
• Surge protection devices
• Installation switches
• Plug and sockets, ...
• Alternators, generators,
uninterruptible power supply (UPS)
• Power transformers
• Contactors
• Industrial robots
• Motion detectors
• Large Motors
• Variable speed drives
• Programmable Logic controllers
• Electrical meters...
EXPLANATION
The RoHS Directive only applies to "equipment
which is dependent on electric currents or
electromagnetic fields in order to work properly
and equipment for the generation, transfer
and measurement of such currents and fields"
• Not listed in the categories 1, 2, 3, 4, 5, 6, 7
and 10 of Annex 1A of the WEEE Directive
and/or
• used in electrical installations for power
distribution, which are not in the scope
of the directive
and/or
• used in Large-scale stationary industrial tools
which are explicitly excluded from the scope
of the directive
GUIDE FOR THE IMPLEMENTATION OF THE RoHS DIRECTIVE
BY MANUFACTURERS OF ELECTRICAL EQUIPMENT
5
6. RoHS DECISION TREE
EEE TO BE IN OR OUT
CONTENTS OF THE DIRECTIVE AND SCOPE OF APPLICATION1
NO
Material, components & parts
of equipment are not considered
to be directly within the scope
of RoHS (see below)
The equipment is a finished product
1
The equipment needs electricity
to fulfil its basic function,
as its primary energy
e.g.,cable management
systems excluded
Equipment dependent on electric
currents or electromagnetic fields,
and equipment for the generation,
transfer and measurement of
such currents and fields
2
YES
YES
NO
NOT COVERED
e.g., High voltage / Low voltage
transformer are excluded
NO
NOT COVERED
Voltage rating not exceeding
1000 V AC / 1500 V DC
3
YES
NO NO
NOT COVERED
Equipment listed in categories
1-2-3-4-5-6-7-10 of Annex 1A
of the WEEE Directive
4
Filament
bulbs or household
luminaire
YES YES
The following EEE are not
in the scope of RoHS:
. medical devices
. monitoring control
instruments
. large-scale stationary
industrial tools
e.g.,Switchgear and controlgear,
protection relays,plug and sockets,
generators,UPS,industrial contactors,
motion detectors,large motors,
variable speed drives,measurement
and monitoring terminals,...
NO
Equipment that is specifically
designed to be installed in airplanes,
aerospace vehicles,boats and
other means of transport is considered
to fall outside the scope of
the RoHS Directive
Equipment,part of equipment
included in product categories
5
YES
COVERED
NOT COVERED
NO
e.g.,Devices intended to be used in electrical
installations for power distribution and
large-scale stationary industrial tools which
are not in the scope of the directive
(switchgear, contactors,VSD, PLC ...)
Compliance requested by integrators (e.g., Timer to maintain household washing machine sold in 2007).
Material,component or part
intended to be incorporated
in equipment “covered”
YES
6
7. TERMS AND DEFINITIONS
A stable legal framework is needed. Common
definitions are necessary to ensure that the
technical requirements for all “RoHS compliant”
electronic and electrical products are exactly
the same in all Member States in order to ensure
free movement and smooth market access for all
electrical and electronic products in the EU
once the Directive enters into force.
MAXIMUM CONCENTRATION
VALUES (MCVS)
The RoHS Directive limits the maximum concentration
values of certain substances.
For the purposes of Article 5-(1)-(a) the Commission
services have published a decision whereby a maximum
concentration value of 0.1% by weight in homogeneous
materials for lead, mercury, hexavalent chromium,
polybrominated biphenyls (PBB), and polybromina-
ted diphenyl ethers (PBDE) and of 0.01% weight in
homogeneous materials for cadmium are allowed.
The actual concentration value is obtained by
dividing the weight of the substance by the weight
of the homogeneous material that contains
this substance.
HOMOGENEOUS MATERIAL
Homogeneous material means a material that
can not be mechanically disjointed into different
materials.
Definitions : The term "homogeneous" means "
of uniform composition throughout". Examples
of "homogeneous materials" are individual types of:
plastics, ceramics, glass, metals, alloys, papers,
resins, and coatings.
The term “mechanically disjointed” means that
the materials can, in principle, be separated by
mechanical actions such as: unscrewing, cutting,
crushing, grinding and abrasive processes.
"PUT ON THE MARKET"
“Put on the market” is the initial action of
making an EEE available for the first time on the
Community market with a view to distribution
or use.
1.3
EXAMPLES
• A plastic cover is a "homogeneous material" if it is made of a single type of plastic and
is not coated with or attached to(or if it envelopes) any other kinds of materials.
In this case the limit values of the directive would apply to the plastic.
• An electric cable that consists of metal wires surrounded by non-metallic insulation materials
is an example of a "non homogeneous material" because the different materials could be
separated by mechanical processes. In this case the limit values of the directive would apply
to each of the separated materials individually.
• A semi-conductor package contains many homogeneous materials that include;
plastic moulding material, tin-electroplating coatings on the lead frame, the lead frame
alloy and gold-bonding wires.
7
GUIDE FOR THE IMPLEMENTATION OF THE RoHS DIRECTIVE
BY MANUFACTURERS OF ELECTRICAL EQUIPMENT
8. CONTENTS OF THE DIRECTIVE AND SCOPE OF APPLICATION1
According to the Frequently Asked Questions
on Directives WEEE & RoHS, published in May
2005 by the European Commission, DG
Environment, “Put on the market” is the initial
action of making a product available for the first
time on the Community market.
This takes place when the product is transferred
(e.g, physical hand-over or transfer of ownership)
from the producer to a distributor or final
consumer or user on the Community market.
“Making a product available for the first time”
refers to each individual piece of equipment put
on the market after the date of the substance’s
restrictions (that is, 1 July 2006), and not to the
launch of a new product or product line. Moreover
the concept of putting on the market refers to each
individual product and not to a type of product,
irrespective of whether it was manufactured as
an individual unit or as part of a series.
The same or a similar term is used in many
directives, such as internal market directives based
on the New Approach and the Global Approach.
The guide4
to the implementation of directives
based on the New Approach and the Global
Approach defines "placing on the market"
as follows:
« Placing on the market is the initial action
of making a product available for the first time on
the Community market, with a view to distribution
or use in the Community.
Making available can be either for payment or
free of charge […] A product is placed on the
Community market when it is made available
for the first time. This is considered to take place
when a product is transferred from the stage
of manufacture with the intention of distribution
or use on the Community market. […]
The transfer of the product takes place either
from the manufacturer, or the manufacturer’s
authorised representative in the Community,
to the importer established in the Community
or to the person responsible for distributing
the product on the Community market.
The transfer may also take place directly from
the manufacturer, or authorised representative
in the Community, to the final consumer or user.
The product is considered to be transferred
either when the physical hand-over or the transfer
of ownership has taken place. This transfer
can be for payment or free of charge, and it
can be based on any type of legal instrument.
Thus, a transfer of a product is considered
to have taken place, for instance,
in the circumstances of sale, loan, hire,
leasing and gift. »
1.4 REMANUFACTURED EQUIPMENT
The Directive "does not apply to spare parts
for the repair, or to the reuse, of electrical and
electronic equipment put on the market before
1 July 2006”. However such spare parts cannot
be used to repair new equipment.
The key date is therefore the date that the original
product was "put on the market," not when it was
returned for repair and/or capacity expansion
and/or upgrade.
Retailers and distributors who have non-RoHS
compliant products in their warehouses after
1st July 2006 can legally sell such products,
provided these products were put on the market
before 1st July 2006. Retailers and distributors
cannot require producers to take back such
products.
4 The guide to the implementation of directives based on the New Approach and Global Approach, published in 2000 by
the European Commission, DG Enterprise. See : http://europa.eu.int/comm/enterprise/newapproach/legislation/guide/legislation.htm
8
9. The use of non-RoHS compliant material in EEE
products put on the market before 1st July 2006
for the purposes of repair and/or capacity
expansion and/or upgrade is allowed in principle
provided that the EEE is not put on the market
as a new product. If after the repair and/or capacity
expansion and/or upgrade the EEE is put on
the market as a new product it should comply
with the RoHS Directive.
However, if after repair and/or capacity expansion
and/or upgrade the EEE is put on the market as a
reused product, the RoHS Directive does not apply.
1.5 EXEMPTIONS
The RoHS Directive exempts some applications
from the substance restrictions, because the use
of hazardous substances in specific materials
and components is technically or scientifically
unavoidable for maintaining suitability for use
and/or safety of EEE. The Annex (B) to the RoHS
Directive lists the exempted applications
The whole exemptions (included in the RoHS
Directive or in its annex) are presented in
the annex of this present document.
Additional exemptions have been proposed,
but have not yet been published in the Official
Journal. Trade Associations will monitor any
proposed changes to this list.
Pursuant to Article 5(1)c of the directive,
each exemption will be reviewed at least every
4 years. Therefore, any response to a customer
request which states “compliant with RoHS
requirements” should be combined with the date
of relevant status of the RoHS legislation.
9
GUIDE FOR THE IMPLEMENTATION OF THE RoHS DIRECTIVE
BY MANUFACTURERS OF ELECTRICAL EQUIPMENT
10. WHAT
INFORMATION
NEEDS TO BE PROVIDED
TO THE CUSTOMER?
2
PRODUCTS FALLING WITHIN THE SCOPE
OF THE RoHS DIRECTIVE
The Directive does not make any provisions, so:
• The RoHS Directive does not require producer
to provide a material declaration
• Compliance should be based on the principle
of the manufacturer’s self and voluntary
declaration. This means that no third party
certification is required.
• If there is a reason to doubt RoHS compliance,
the producer who put the product on the market
must be able, at the request of the market
surveillance authority, to demonstrate compliance
through documentation. The producer could
provide evidence such as declarations of
conformity for components and materials,
test results, evidence of evaluation of suppliers,
contractual agreements with suppliers, or other
suitable material.
• If tests are necessary, they should be performed
according to published standards.
PRODUCT MARKING
The RoHS Directive does not require any product
marking5
. CE marking is not relevant, presently,
for RoHS matters.
Neither does the wheeled bin provided by
WEEE directive.
2.1
5 The WEEE Directive requires a specific marking that is not linked to the RoHS Directive.
2.2 PRODUCTS FALLING OUTSIDE THE SCOPE
OF THE RoHS DIRECTIVE
There are no regulatory obligations for any
products that fall outside the scope of the RoHS
DirectiveRoHS Directive. It is perfectly legal to
buy and sell products that are not in the scope
of the Directive, even if they do not meet
the material restrictions specified in the RoHS
Directive RoHS Directive.
10
11. GUIDE FOR THE IMPLEMENTATION OF THE RoHS DIRECTIVE
BY MANUFACTURERS OF ELECTRICAL EQUIPMENT
HOW TO ANSWER TO THE CUSTOMER'S QUESTIONS
SHORT ANSWER:
• «All necessary dispositions have been taken in relation with suppliers to ensure that
constitutive materials do not include any substance forbidden by the regulations currently
applicable on the market.»
• To be used for a finished product:
• «We hereby confirm (legally binding) that all products supplied to you meet the requirements
of the RoHS Directive (Status: ... Date of actual version).»
or
• To be used as a component:
• «Our components supplied to you meet the material restrictions specified in the RoHS Directive.»
or
• «We are in the process of checking our products and we will inform you
of the results no later than (... Date).»
ANSWER IN CASE OF AN EXEMPTION OR IN CASE OF VOLUNTARY SUBSTITUTION:
• «For new developments we will be able to substitute these substances in future (from date ...).»
• «For technical (or other) reasons, a substitution of these substances is unfortunately
not possible today.»
• «Our products supplied to you do not fall under the scope of Directive 2002/95/EC ("RoHS").
They also will not be incorporated – according to our knowledge – into products falling under
the scope of this directive. Should you wish our products to still meet the requirements of RoHS,
a suitable contract would need to be agreed.»
• «Our products supplied to you contain substances (substance xxx) which are restricted
by Directive 2002/95/EC (“RoHS”) (add list of products if necessary). As an alternative solution
we can offer from (date xxx) the following material(s) substitution(s): xxx. Please give us
your approval to release these products.»
ANSWER FOR PARTS OF A FIXED INSTALLATION
(e.g., industrial monitoring, controls and drive components):
• «This product is intended to be part of a "large-scale stationary industrial tool".
Based on Directive 2002/95/EC, published on 13th February 2003 and the European Commission's
“Frequently asked questions” paper dated May 2005, “large-scale stationary industrial tool"
are explicitly outside the scope of RoHS (and of WEEE) and are therefore not subject
to the material restrictions specified in this Directive.»
11
12. ANNEXE
EXEMPTIONS
INCLUDED
in the RoHS
Directive
2002/95/EC
• Equipment which falls under categories 8 and 9 set out in Annex IA
to WEEE Directive 2002/96/EC
• Spare parts for the repair, or to the reuse, of electrical and electronic
equipment put on the market before 1 July 2006
• Batteries and accumulators
EXEMPTIONS
LISTED
in the annex
to RoHS Directive
2002/95/EC
Update 12/08/05
• Mercury in compact fluorescent lamps not exceeding 5 mg per lamp
• Mercury in straight fluorescent lamps for general purposes not exceeding
10 mg for halophosphate, 5 mg for triphosphate with normal lifetime,
8 mg for triphosphate with long lifetime
• Mercury in straight fluorescent lamps for special purposes
• Mercury in other lamps not specifically mentioned in the Annex
• Lead in glass of cathode ray tubes, electronic components
and fluorescent tubes
• Lead as an alloying element in steel containing up to 0,35% lead
by weight, aluminium containing up to 0,4% lead by weight and
as a copper alloy containing up to 4% lead by weight.
• Lead in high melting temperature type solders
(i.e. tin-lead solder alloys containing more than 85 % lead)
• Lead in solders for servers, storage and storage array systems,
network infrastructure equipment for switching, signalling, transmission
as well as network management for telecommunication*
• Lead in electronic ceramic parts (e.g. piezoelectronic devices).
• Cadmium and its compounds in electric contacts*
• Cadmium plating except for applications banned under
Directive 91/338/EEC (1) amending Directive 76/769/EEC (2) relating
to restrictions on the marketing and use of certain dangerous
substances and preparations.
• Hexavalent chromium as an anti-corrosion of the carbon steel
cooling system in absorption refrigerators
• Lead used in compliant pin connector systems*
• Lead as a coating material for the thermal conduction module c-ring*
• Lead in solders consisting of more than two elements for the connection
between the pins and the package of microprocessors with a lead
content of more than 80% and less than 85% by weight*
• Lead in solders to complete a viable electrical connection
between semiconductor die and carrier within integrated circuit
Flip Chip packages*
• Lead and cadmium in optical and filter glass*
* Exemptions to be considered as obtained (voted in 2005, but not yet published in the OJEU).
GIMELEC : French industry assocation for electrical equipment,automation and related services.
DOMERGIE : Manufacturers association of electrical installation equipment and home automation application.
12