Regulation of software as medical devicesTGA Australia
Software can be regulated as a medical device if it meets the definition under Australian law. The intended purpose of the software must be for diagnosis, prevention, monitoring, treatment or alleviation of disease or injury. Regulators are working to clarify how quality management system principles apply to software. Post-market, issues can include software crossing regulatory lines over multiple upgrades and not properly reporting safety incidents.
This document summarizes a presentation on future compliance requirements related to medical devices. It discusses changes coming in how medical devices are named (GMDN), tracked (UDI), and have data captured (AIDC/GS1 coding). The Global Medical Device Nomenclature (GMDN) will standardize device names. Unique Device Identification (UDI) will assign each device a unique identifier tracked in a public database. Automatic identification like GS1 coding will help interface equipment and data. Hospitals should prepare by understanding these changes to integrate new identification standards.
The document provides an overview of unique device identification (UDI) regulations in the United States. It defines key terms related to UDI such as device identifier and production identifier. It explains that UDI is composed of these two identifiers and facilitates rapid identification of medical devices. The document also summarizes UDI requirements including placement of UDI on labels and packages, direct marking requirements, exceptions, and compliance dates. It describes the Global Unique Device Identification Database where UDI information must be submitted.
The document summarizes the regulation of in vitro diagnostic (IVD) medical devices in Australia. It outlines the regulatory framework, classification system, conformity assessment process, and key aspects of an inclusion application for IVD devices to be entered into the Australian Register of Therapeutic Goods (ARTG). The summary highlights that IVD devices are regulated under the Therapeutic Goods Act and must comply with essential principles, be appropriately classified, and have evidence of conformity assessment submitted with ARTG applications, which may be subject to audit.
The document discusses design controls, which are a set of quality practices and procedures incorporated into the design and development process to control the design process and ensure medical device specifications meet user needs and intended use. It provides an overview of the seven key elements of design controls according to FDA regulations: design and development planning, design input, design output, design review, design verification, design validation, and design changes. It emphasizes that design controls are important for medical device safety and quality.
Overview of FDA Regulation of Medical DevicesMichael Swit
The document is a slide presentation by Michael A. Swit, Esq. on an overview of FDA regulation, with an emphasis on medical devices. It begins with definitions of key terms under FDA regulation such as drugs, biologics, devices, foods, dietary supplements, and cosmetics. It then discusses the mission and structure of the FDA, including the different centers that regulate specific product areas. The presentation provides an overview of the classification system for medical devices and regulatory pathways for devices, including 510(k) clearance and premarket approval.
The document discusses key changes and requirements regarding the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) and the European database on medical devices (Eudamed). Some of the main points discussed include:
- Eudamed will contain integrated electronic systems for European UDI, registration of devices and economic operators, scrutiny applications, certificates, clinical investigations, vigilance, and market surveillance.
- Traceability requirements will require manufacturers, distributors, and importers to cooperate to achieve appropriate traceability levels and identify economic operators in the supply chain.
- Unique Device Identification (UDI) must be assigned and placed on labels and packaging. Registrations of devices and economic
Regulation of software as medical devicesTGA Australia
Software can be regulated as a medical device if it meets the definition under Australian law. The intended purpose of the software must be for diagnosis, prevention, monitoring, treatment or alleviation of disease or injury. Regulators are working to clarify how quality management system principles apply to software. Post-market, issues can include software crossing regulatory lines over multiple upgrades and not properly reporting safety incidents.
This document summarizes a presentation on future compliance requirements related to medical devices. It discusses changes coming in how medical devices are named (GMDN), tracked (UDI), and have data captured (AIDC/GS1 coding). The Global Medical Device Nomenclature (GMDN) will standardize device names. Unique Device Identification (UDI) will assign each device a unique identifier tracked in a public database. Automatic identification like GS1 coding will help interface equipment and data. Hospitals should prepare by understanding these changes to integrate new identification standards.
The document provides an overview of unique device identification (UDI) regulations in the United States. It defines key terms related to UDI such as device identifier and production identifier. It explains that UDI is composed of these two identifiers and facilitates rapid identification of medical devices. The document also summarizes UDI requirements including placement of UDI on labels and packages, direct marking requirements, exceptions, and compliance dates. It describes the Global Unique Device Identification Database where UDI information must be submitted.
The document summarizes the regulation of in vitro diagnostic (IVD) medical devices in Australia. It outlines the regulatory framework, classification system, conformity assessment process, and key aspects of an inclusion application for IVD devices to be entered into the Australian Register of Therapeutic Goods (ARTG). The summary highlights that IVD devices are regulated under the Therapeutic Goods Act and must comply with essential principles, be appropriately classified, and have evidence of conformity assessment submitted with ARTG applications, which may be subject to audit.
The document discusses design controls, which are a set of quality practices and procedures incorporated into the design and development process to control the design process and ensure medical device specifications meet user needs and intended use. It provides an overview of the seven key elements of design controls according to FDA regulations: design and development planning, design input, design output, design review, design verification, design validation, and design changes. It emphasizes that design controls are important for medical device safety and quality.
Overview of FDA Regulation of Medical DevicesMichael Swit
The document is a slide presentation by Michael A. Swit, Esq. on an overview of FDA regulation, with an emphasis on medical devices. It begins with definitions of key terms under FDA regulation such as drugs, biologics, devices, foods, dietary supplements, and cosmetics. It then discusses the mission and structure of the FDA, including the different centers that regulate specific product areas. The presentation provides an overview of the classification system for medical devices and regulatory pathways for devices, including 510(k) clearance and premarket approval.
The document discusses key changes and requirements regarding the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) and the European database on medical devices (Eudamed). Some of the main points discussed include:
- Eudamed will contain integrated electronic systems for European UDI, registration of devices and economic operators, scrutiny applications, certificates, clinical investigations, vigilance, and market surveillance.
- Traceability requirements will require manufacturers, distributors, and importers to cooperate to achieve appropriate traceability levels and identify economic operators in the supply chain.
- Unique Device Identification (UDI) must be assigned and placed on labels and packaging. Registrations of devices and economic
IEC 60101-1 is basic certificate for the general purpose as below items :
MEDICAL ELECTRICAL EQUIPMENT
MEDICAL ELECTRICAL SYSTEMS: Assembled by several medical electrical equipment
Components that is used in above equipment
This document provides guidance for carrying out pre-commissioning checks and tests for switchyard equipment at Power Grid Corporation of India Ltd. It outlines the constitution and responsibilities of the commissioning team, general safety procedures, documentation requirements, and pre-commissioning formats for recording test results. Specific guidance is provided for transformers, reactors, and other switchyard equipment such as circuit breakers, current transformers, surge arresters, and more. The aim is to ascertain the correctness and completeness of installation and healthiness of equipment before charging.
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
The document provides guidelines for reviewing transformer factory acceptance tests (FAT), including routine tests and design tests. It lists the information that should be on the transformer nameplate and tables outlining the design and routine tests that should be performed, including tests like temperature rise tests, insulation resistance tests, ratio tests, no-load loss tests, and operational tests of ancillary equipment. The guidelines are intended to help Saudi Aramco engineers ensure transformers meet design and quality requirements before shipping.
This document describes procedures for testing power transformers at AREVA's factory in Gebze, Turkey. It outlines both routine and type tests performed on transformers to check electrical characteristics and dielectric strength according to customer specifications and industry standards. Routine tests include measuring voltage ratios, winding resistances, losses, dielectric strength, and tap changer operation. Type tests evaluate temperature rise, impedances, insulation levels, sound, and impulse withstand capabilities. Test equipment used is also listed. The document provides details on measurement methods and circuits for key tests like voltage ratios, winding resistances, and vector relationships.
The document discusses the new IEC 61439 standard for low-voltage switchgear and controlgear assemblies, which replaces the previous IEC 60439 standard. Some key changes in IEC 61439 include splitting responsibility between original manufacturers and assembly manufacturers, replacing type testing with design verification through testing, calculation, or application of design rules, and requiring a routine verification for each completed assembly. The new standard provides a formal hierarchy with Part 1 covering general rules and additional parts addressing specific assembly types.
The new Medical Device Regulation Classification is changing with the (EU) 2017/745. I prepared an infographic and free forms to use to define if the class of your product changed. This Cheat Sheet is helping you to see a summary of each rule. Medical Devices are classified in 4 class from the one with lower risk to the one with higher risk. Each class is defining how you can get the CE mark of your product. Come and learn on easymedicaldevice.com how to be an expert on medical devices.
The document provides information about the 66kV grid substation located in Jalandhar, Punjab, India. It discusses the key equipment installed at the substation including 3 transformers, circuit breakers, isolators, current transformers, potential transformers, lightning arrestors, and wave traps. It also provides brief summaries of the functions and operating principles of these various types of equipment that comprise the 66kV distribution and transmission system. The document aims to describe the technical specifications and functionalities of the core infrastructure that enables power distribution at this substation.
This document discusses primary injection testing of transformers with 415V AC and calculations to determine currents. It provides calculations to determine the full load current on the high voltage and low voltage sides of the transformer. It also discusses selecting the proper CT ratio between the primary and secondary of the transformer. The document then discusses using a differential busbar protection scheme to isolate only the faulty section of a busbar during a fault, in less than 0.1 seconds, to ensure system stability. This is an improvement over earlier distance protection or overcurrent schemes which could not discriminate the faulty section or had longer operating times.
The document discusses medical device adverse event reporting requirements, including definitions of reportable events and timelines for submitting reports to regulatory agencies. It provides an overview of the classification system for medical devices and regulations around reporting malfunctions, deaths and serious injuries caused by devices. Reporting requirements and challenges involving software as a medical device are also reviewed.
This document discusses power system protection settings. It begins by introducing the functions of protective relays and the information needed to calculate settings, such as line parameters, transformer parameters, fault studies results, and CT and VT ratios. It then describes the protection settings process and functional elements of protective relays. The document discusses the operating characteristics of overcurrent, directional, and distance protection elements. It explains concepts like current grading, time grading, and directional elements as they relate to achieving selectivity in protection schemes. Finally, it provides more details on distance protection principles and operating characteristics.
Rules and regulations for medical device registration, forms and fees required, types of medical devices to be registered under CDSCO India.
Indian market overview
India’s medical device regulatory structure
Categories of regulated medical devices in India
No Objection Certificates
Device Registration Certificate applications
Import Licensing
India Authorized Agent selection
Costs and Timelines
Developing Regulatory Issues in India
IEC 60601-1-2 applies to the electromagnetic compatibility (EMC) of electrical medical equipment.
IEC 60101-1-2 4th edition was released in 2014 and will be required after December 31st, 2018.
There are some large changes with the EMC requirements which will have an effect on medical power supplies and Medical Electrical Equipment (ME)
This document provides an overview of the FDA 510(k) submission process for medical devices. It begins with background on FDA authority over medical devices and device classification. It then covers key aspects of preparing a 510(k) submission, including what a 510(k) is, where and when to start the process, how FDA reviews submissions, and tips for formatting a 510(k). The document reviews the typical 510(k) review cycle and outcomes, including potential requests for additional information and decisions of substantial equivalence or non-equivalence. It aims to help medical device companies navigate the 510(k) process and timelines.
The STED (Summary of Technical Documentation) is a document that manufacturers of IVD medical devices must compile to demonstrate conformity with regulations. It provides:
1) A detailed description of the device's intended purpose and performance.
2) Information on design, manufacturing, safety and performance testing to show compliance with standards.
3) A checklist mapping requirements to how the device meets each essential principle.
The STED is required for premarket review of Class C and D devices and may be requested post-market. It provides regulators a summary of a device's technical file for audit purposes. Higher risk devices require more detailed information in the STED. The level of information helps determine conformity.
Update on software as a medical device (SaMD)TGA Australia
This presentation explores the definition of a medical device and how this applies to software. In addition, the nuances of the kinds of software are discussed in relation to their likely classification as a medical device.
Japan PMDA Medical Device Regulatory Approval ProcessEMERGO
Watch the recorded webinar: https://www.emergogroup.com/resources/video-webinar-japan-registration-process
Japan's medical device market is one of the most robust markets in Asia, but its regulatory system can be confusing. Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply to your device, which steps to take, and what resources are required to complete the process. In this presentation, Ann Marie Boullie, Vice President of Business Development for EMERGO, will discuss some of the most complex aspects of the Japanese registration process, including:
JMDN codes: device classification and predicates
Clinical data requirements and PMDA pre-submission meetings
Registration routes (Todokede, Ninsho, Shonin)
QMS (Ordinance 169) requirements
Role of the Marketing Authorization Holder (MAH)
Plus more ...
1) The document discusses the application of Australian standards for routine testing of high voltage switchgear, specifically AS 62271.200 for metal enclosed switchgear between 1kV and 52kV.
2) It outlines the various routine tests required by the standard, including dielectric tests on the main circuit and auxiliary circuits, measurement of resistance of the main circuit, and tightness checks.
3) The dielectric tests involve applying power frequency voltage to verify no disruptive discharge occurs, with test voltages specified in the standard based on the rated voltage of the switchgear.
This document is the Indian Standard specification for PVC insulated electric cables with working voltages from 3.3 kV up to and including 11 kV. It outlines the key materials and construction requirements for single-core unscreened, single-core screened, single-core armored, and three-core armored PVC insulated cables. The standard specifies requirements for conductors, insulation, screening, fillers, inner sheaths, armorings, and outer sheaths. It also provides thickness requirements for insulation and inner sheaths. The purpose is to specify standards for PVC insulated electric cables to ensure safe and reliable performance when used for electricity supply purposes in India.
IEC 60101-1 is basic certificate for the general purpose as below items :
MEDICAL ELECTRICAL EQUIPMENT
MEDICAL ELECTRICAL SYSTEMS: Assembled by several medical electrical equipment
Components that is used in above equipment
This document provides guidance for carrying out pre-commissioning checks and tests for switchyard equipment at Power Grid Corporation of India Ltd. It outlines the constitution and responsibilities of the commissioning team, general safety procedures, documentation requirements, and pre-commissioning formats for recording test results. Specific guidance is provided for transformers, reactors, and other switchyard equipment such as circuit breakers, current transformers, surge arresters, and more. The aim is to ascertain the correctness and completeness of installation and healthiness of equipment before charging.
Medical Devices registration in Japan , quality system requirements and evaluation and investigation of medical devices in regulated countries ASEAN, China JAPAN and WHO regulations. quality and ethical considerations regulatory and documentation requirements for marketing medical devices and IVDs in regulated countries.
The document provides guidelines for reviewing transformer factory acceptance tests (FAT), including routine tests and design tests. It lists the information that should be on the transformer nameplate and tables outlining the design and routine tests that should be performed, including tests like temperature rise tests, insulation resistance tests, ratio tests, no-load loss tests, and operational tests of ancillary equipment. The guidelines are intended to help Saudi Aramco engineers ensure transformers meet design and quality requirements before shipping.
This document describes procedures for testing power transformers at AREVA's factory in Gebze, Turkey. It outlines both routine and type tests performed on transformers to check electrical characteristics and dielectric strength according to customer specifications and industry standards. Routine tests include measuring voltage ratios, winding resistances, losses, dielectric strength, and tap changer operation. Type tests evaluate temperature rise, impedances, insulation levels, sound, and impulse withstand capabilities. Test equipment used is also listed. The document provides details on measurement methods and circuits for key tests like voltage ratios, winding resistances, and vector relationships.
The document discusses the new IEC 61439 standard for low-voltage switchgear and controlgear assemblies, which replaces the previous IEC 60439 standard. Some key changes in IEC 61439 include splitting responsibility between original manufacturers and assembly manufacturers, replacing type testing with design verification through testing, calculation, or application of design rules, and requiring a routine verification for each completed assembly. The new standard provides a formal hierarchy with Part 1 covering general rules and additional parts addressing specific assembly types.
The new Medical Device Regulation Classification is changing with the (EU) 2017/745. I prepared an infographic and free forms to use to define if the class of your product changed. This Cheat Sheet is helping you to see a summary of each rule. Medical Devices are classified in 4 class from the one with lower risk to the one with higher risk. Each class is defining how you can get the CE mark of your product. Come and learn on easymedicaldevice.com how to be an expert on medical devices.
The document provides information about the 66kV grid substation located in Jalandhar, Punjab, India. It discusses the key equipment installed at the substation including 3 transformers, circuit breakers, isolators, current transformers, potential transformers, lightning arrestors, and wave traps. It also provides brief summaries of the functions and operating principles of these various types of equipment that comprise the 66kV distribution and transmission system. The document aims to describe the technical specifications and functionalities of the core infrastructure that enables power distribution at this substation.
This document discusses primary injection testing of transformers with 415V AC and calculations to determine currents. It provides calculations to determine the full load current on the high voltage and low voltage sides of the transformer. It also discusses selecting the proper CT ratio between the primary and secondary of the transformer. The document then discusses using a differential busbar protection scheme to isolate only the faulty section of a busbar during a fault, in less than 0.1 seconds, to ensure system stability. This is an improvement over earlier distance protection or overcurrent schemes which could not discriminate the faulty section or had longer operating times.
The document discusses medical device adverse event reporting requirements, including definitions of reportable events and timelines for submitting reports to regulatory agencies. It provides an overview of the classification system for medical devices and regulations around reporting malfunctions, deaths and serious injuries caused by devices. Reporting requirements and challenges involving software as a medical device are also reviewed.
This document discusses power system protection settings. It begins by introducing the functions of protective relays and the information needed to calculate settings, such as line parameters, transformer parameters, fault studies results, and CT and VT ratios. It then describes the protection settings process and functional elements of protective relays. The document discusses the operating characteristics of overcurrent, directional, and distance protection elements. It explains concepts like current grading, time grading, and directional elements as they relate to achieving selectivity in protection schemes. Finally, it provides more details on distance protection principles and operating characteristics.
Rules and regulations for medical device registration, forms and fees required, types of medical devices to be registered under CDSCO India.
Indian market overview
India’s medical device regulatory structure
Categories of regulated medical devices in India
No Objection Certificates
Device Registration Certificate applications
Import Licensing
India Authorized Agent selection
Costs and Timelines
Developing Regulatory Issues in India
IEC 60601-1-2 applies to the electromagnetic compatibility (EMC) of electrical medical equipment.
IEC 60101-1-2 4th edition was released in 2014 and will be required after December 31st, 2018.
There are some large changes with the EMC requirements which will have an effect on medical power supplies and Medical Electrical Equipment (ME)
This document provides an overview of the FDA 510(k) submission process for medical devices. It begins with background on FDA authority over medical devices and device classification. It then covers key aspects of preparing a 510(k) submission, including what a 510(k) is, where and when to start the process, how FDA reviews submissions, and tips for formatting a 510(k). The document reviews the typical 510(k) review cycle and outcomes, including potential requests for additional information and decisions of substantial equivalence or non-equivalence. It aims to help medical device companies navigate the 510(k) process and timelines.
The STED (Summary of Technical Documentation) is a document that manufacturers of IVD medical devices must compile to demonstrate conformity with regulations. It provides:
1) A detailed description of the device's intended purpose and performance.
2) Information on design, manufacturing, safety and performance testing to show compliance with standards.
3) A checklist mapping requirements to how the device meets each essential principle.
The STED is required for premarket review of Class C and D devices and may be requested post-market. It provides regulators a summary of a device's technical file for audit purposes. Higher risk devices require more detailed information in the STED. The level of information helps determine conformity.
Update on software as a medical device (SaMD)TGA Australia
This presentation explores the definition of a medical device and how this applies to software. In addition, the nuances of the kinds of software are discussed in relation to their likely classification as a medical device.
Japan PMDA Medical Device Regulatory Approval ProcessEMERGO
Watch the recorded webinar: https://www.emergogroup.com/resources/video-webinar-japan-registration-process
Japan's medical device market is one of the most robust markets in Asia, but its regulatory system can be confusing. Before deciding to sell your device in the Japanese market, it is important to understand how the regulations apply to your device, which steps to take, and what resources are required to complete the process. In this presentation, Ann Marie Boullie, Vice President of Business Development for EMERGO, will discuss some of the most complex aspects of the Japanese registration process, including:
JMDN codes: device classification and predicates
Clinical data requirements and PMDA pre-submission meetings
Registration routes (Todokede, Ninsho, Shonin)
QMS (Ordinance 169) requirements
Role of the Marketing Authorization Holder (MAH)
Plus more ...
1) The document discusses the application of Australian standards for routine testing of high voltage switchgear, specifically AS 62271.200 for metal enclosed switchgear between 1kV and 52kV.
2) It outlines the various routine tests required by the standard, including dielectric tests on the main circuit and auxiliary circuits, measurement of resistance of the main circuit, and tightness checks.
3) The dielectric tests involve applying power frequency voltage to verify no disruptive discharge occurs, with test voltages specified in the standard based on the rated voltage of the switchgear.
This document is the Indian Standard specification for PVC insulated electric cables with working voltages from 3.3 kV up to and including 11 kV. It outlines the key materials and construction requirements for single-core unscreened, single-core screened, single-core armored, and three-core armored PVC insulated cables. The standard specifies requirements for conductors, insulation, screening, fillers, inner sheaths, armorings, and outer sheaths. It also provides thickness requirements for insulation and inner sheaths. The purpose is to specify standards for PVC insulated electric cables to ensure safe and reliable performance when used for electricity supply purposes in India.
The document provides information about ABB's medium voltage V-Contact VSC contactors. It describes the contactors' permanent magnet drive system and vacuum interrupter breaking mechanism. It lists the available contactor versions and their technical specifications, including voltage ratings, short circuit ratings, switching times, and environmental compliance standards. Installation and application information is also provided.
This document provides guidance on designing medium voltage switchgear. It discusses key considerations like voltage, current, frequency, and switchgear functions. It also covers short-circuit power calculations, determining short-circuit currents from transformers, generators and motors. Guidelines are provided on busbar calculations for thermal withstand, electrodynamic withstand and intrinsic resonant frequency. Other topics include dielectric withstand, part shapes and distances, and protection indexes. The document aims to provide design rules and calculation methods to help engineers properly size and select equipment for medium voltage switchboards.
Abstract- This paper presents a major revision of the Universal Four Leg ‘DC Grid Laboratory Experimental Setup’. This revision includes the reduction of current loops, the increase of efficiency in the power stage, the expansion of measurement possibilities and the re-specification of the input/output range.
To deal with an ever present complication in the world of measurements, simple fuse holders are converted into dedicated probe measurement connectors. These connectors reduce large ground loops to a minimum.
Key features include a clear board layout and silkscreen, a tremendous reduction of semiconductor losses resulting in a heatsink-less power stage and easy, reliable probe and power connections. Provisions are made for a Single Board Computer (SBC) to read and control the Universal Four Leg V4. The SBC can also be used to communicate with external devices to allow for remote control of the Universal Four Leg and the presentation of measurements performed.
The Universal Four Leg is a power management device with a wide range of applications in both higher educational laboratory courses, as well as a dedicated grid manager in low voltage DC-grids.
The document summarizes changes made in amendments to IEC 60947-2, the technical standard for low-voltage circuit breakers. Some key changes include:
- Addition of new tests like the critical DC current test to evaluate performance of DC circuit breakers.
- Clarification of tests required for circuit breakers used in enclosures.
- Updates to tests for dielectric properties, selectivity, and non-tripping duration.
- New annexes added on topics like residual current protection with auto-reclosing functions and DC circuit breakers for photovoltaic applications.
This document analyzes grounding considerations for large kVA pad-mount transformers. It summarizes the assumptions made in analyzing different transformer voltages and kVA sizes up to 5,000 kVA. Calculations of ground potential rise, touch potential and step potential are performed and compared to safety limits. Results show the standard two ground rod system may not provide adequate protection for transformers over 750 kVA or higher secondary voltages. Larger or engineered grounding systems are recommended for safety.
The document discusses grounding considerations for large kVA pad-mount transformers. It analyzes grounding systems for pad-mounts up to 5,000 kVA to ensure step and touch potentials are limited to safe levels. Calculations were performed using IEEE standards to determine the maximum allowable touch and step voltages. Results showed the standard two ground rod system may not limit surface potentials for all sizes, while the Canadian four rod standard provided better but still insufficient results for some larger transformers. Recommendations are made to properly design grounding to render pad-mounts safe for the public and workers.
This document summarizes an inspection of a solar photovoltaic system installation and identifies some potential issues. It analyzes a 24-module system and a 40-module system. For the 24-module system, it determines that the wiring size and overcurrent protection are adequate but the equipment grounding wire may be too small. For the 40-module system, it initially finds the wiring from the junction box to the inverter to be undersized, but identifying a larger wire size resolves this. It also confirms the DC circuit breaker and fuse sizes are properly rated for the system specifications. However, it finds the equipment grounding wire for the PV modules is too small based on the rating of the DC circuit breaker
1. There are three main tests used to validate the function of vacuum interrupters: contact resistance testing, high potential withstand testing, and leak rate testing.
2. Contact resistance testing measures the resistance of the closed contacts and compares it to design values. High potential testing applies a high voltage to open contacts to measure any leakage current.
3. Leak rate testing uses the Penning discharge principle - applying a high voltage and magnetic field to contacts to determine the internal gas pressure based on the amount of current, indicating the leak rate. A high leak rate can shorten the life of vacuum interrupters.
2011 12-33kv tech.spec for v c b type- m2-c1-revisedBasudev patra
This document provides the technical specifications for 33kV outdoor type vacuum circuit breakers. Key details include:
- Scope covers design, manufacturing, assembly and testing of 33kV, 1250A, 25kA circuit breakers.
- Circuit breakers must meet Indian and international standards. They will be installed in West Bengal with ambient temperatures up to 50°C.
- Design criteria includes interrupting fault levels of 20kA, continuous current rating of 1250A, and operating duty of 0-0.3 sec-CO-3 min-CO.
Results of 10 years after installation tests with partial discharge detection...HighVoltageDUT
In 2004 Alliander decided to add partial discharge (PD) measurements in their after installation test policy. Over the last years, dozens of accessories and a few cable parts were taken out of the tested cables, based on PD activity, measured during after installation test. In many cases severe abnormalities were found, threatening the reliability of the cable system, but also cases were found where the reason for PD was not clear. It is also discovered that cable systems can contain PD’s in accessories but still survive the after installation test.
Brugg Kabel AG uses silicone insulation for high voltage cable accessories up to 400kV. Routine partial discharge (PD) testing is done on prefabricated joints to ensure quality and detect defects. On-site PD measurements after installation can accurately detect PD above 5pC and localize faults. Directional coupler sensors allow sensitive PD detection and localization in unscreened environments. PD testing is important for ensuring reliability of joints and avoiding premature failures during operation.
This document discusses residual current devices (RCDs) and their standards and testing. It provides background on the development of RCDs from early voltage-operated devices to current-driven RCDs. It describes the standards that define RCD classifications, requirements, and clearance times. Testing of RCDs to standards is discussed, highlighting the importance of accurate testing and factors that influence trip times, such as body impedance. Maintaining effective earthing and insulation is noted as important for test accuracy. Faster trip times are suggested to meet standards of as low as reasonably practicable.
This standard describes two methods for detecting holidays or defects in pipeline coatings:
Method A uses low voltage (less than 100 V DC) and is suitable for thin coatings up to 20 mils thick. It can detect pinholes and voids but not thin spots in the coating.
Method B uses higher voltages (900-20,000 V DC) and can detect pinholes, voids, and thin spots in coatings of any thickness. It is considered destructive because the high voltage can damage thin areas of the coating.
Both methods work by completing an electrical circuit through any defects in the otherwise insulating pipeline coating, activating an audible alarm to locate the holiday. Precise procedures and reporting requirements
DIGITAL TESTING OF HIGH VOLTAGE CIRCUIT BREAKERRitesh Kumawat
1. The document discusses the testing of high voltage circuit breakers. Digital testing employs software to simulate circuit breaker performance based on characteristic measurements from standard tests.
2. High resolution current and voltage measurements are made around current zero crossing to characterize breaker behavior. An empirical arc model is validated and used to predict test outcomes.
3. The software can be used to study the influence of system components on breaker performance and determine critical line lengths for short line faults by simulating different test circuits digitally.
The M4100 is the world's premier power apparatus and insulation test instrument. It has unique test capabilities and AI analysis software making it the most trusted instrument in the power industry. These instruments are used globally thanks to comprehensive testing options, safety features, and measurement accuracy. The latest 4th generation M4100 has improved ruggedness, accuracy, universal controller compatibility, expanded software, and safety features.
This document provides testing procedures for switchgear and controlgear. It outlines dielectric tests on the main circuit to check insulation as well as tests on auxiliary and control circuits. Visual inspections are also specified to check components, wiring, and that no conductors can be damaged. Separate tests are required if the equipment is not fully assembled during transport.
Topological Advancement in DVR; A reviewIRJET Journal
This document provides a review of topological advancements in dynamic voltage restorers (DVRs). It begins with an introduction to DVRs and their use in mitigating voltage sags and swells. It then discusses various DVR topologies that have been proposed, including designs using voltage source inverters, multi-level inverters, designs with and without energy storage, AC link converters, and interline configurations. The document concludes with a discussion of control architectures for DVRs and a review of the various topologies presented.
ZVS Circuit based – Cockcroft Walton High Voltage DC GeneratorIRJET Journal
This document describes a ZVS (zero voltage switching) circuit based Cockcroft Walton high voltage DC generator. It begins with an abstract that outlines the uses of high voltage DC power supplies and discusses the challenges with existing designs. It then provides details of the key components in the proposed design - a ZVS driver to generate high frequency AC, a flyback transformer to boost the voltage, and a Cockcroft Walton voltage multiplier to produce high voltage DC output. The advantages of this design are improved performance, lower cost due to using fewer stages, and increased flexibility and portability by operating on a small battery. Applications discussed include cable insulation testing, impulse generators, particle accelerators, and medical X-ray equipment.
Similar to 61010 national difference for slideshare (20)
If you are selling medical devices in the US, your devices are subject to new regulatory requirements under the FDA Unique Device Identification (UDI) rule.
UL experts have been actively working with customers with gap assessments, project planning and more to support compliance with these requirements. In this webinar, Ms. Linda Chatwin, RAC will be sharing some of our key learnings.
UL offers a full suite of services to support compliance with FDA's UDI Rule.
For more information, please contact us and request a sell sheet at Medical.Inquiry@ul.com, visit our UDI webpage or speak directly with one of our experts at 1-877-854-3577 or +91 804 138 4434
http://industries.ul.com/blog/us-fda-unique-device-identification-udi-implementation-deadline-in-place-for-medical-devices
eHealth - Medical Systems Interoperability & Mobile Healthulmedical
The Medical Device industry is rapidly adopting technologies that enable communication and connectivity of health products and systems to improve both speed and quality of care as well as patient safety. The users (i.e. hospitals and others) are demanding an approach that will support interoperability among multiple independently sourced medical devices. Industry will require standardization to support such interoperability. Government and regulators, on behalf of the patients and in compliance with their mission to protect public health, as well as users and manufacturers require that such interoperability is safe. This complementary webinar will introduce the eHealth sector and applications, outline the challenges and risks inherent in connecting heterogeneous equipment into medical device systems, and provide insights to how manufacturers can demonstrate compliance with the rapidly changing regulatory landscape for interoperable medical devices.
This webinar was presented by UL eHealth experts on October 30, 2013.
UL Webinar - Updates to the Regulatory Framework in Korea and their impact to...ulmedical
fIn this presentation UL technical expert, MinYong Choi, formerly with the Korea FDA provides a comprehensive overview of the Regulatory framework for medical and IVD devices in Korea. The presentation includes useful links, and insight into recent and planned changes to the regulations that may affect submissions for market approval.
“CFDA Registration – Market Access Before Investment” delivered by Tim Lin, T...ulmedical
Due to a large population, increasing middle class and government plans to build tens of thousands of hospitals, there is a lot of demand for high quality medical devices in China. For many foreign medical device manufacturers, the regulatory barriers are still significant obstacles.
The medical device regulation in China is less harmonized and generally unique from other major markets. The primary challenges tend to be: actual testing, drafting standards, language barriers and license parking. These additional requirements create a delay in the registration process.
Foreign manufacturers need to specifically understand the Chinese medical device regulation in advance, and then are able to determine appropriate strategies aimed at successful China market entry.
This is the content for a live webinar, "CFDA Registration, Market Access before Investment...Solving the CFDA Challenge" delivered by UL's Tim Lin. Tim is the Senior Technical Consultant working in the Greater China Region. He majored in public health and medical device engineering, and worked as a reviewer in the Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 5 years; and also drafted guidance for industry. He is now responsible for risk management file, usability engineering, software validation and CE MDD technical documentation.
UL is a notified body under the IVD directive and UL experts understand the impact of the upcoming regulatory revisions. Visit www.ul.com/medical-cemark for more information on working with UL as your Notified Body.
3. Permissible Limits for Accessible Parts
Normal Condition (6.3.1)
• Voltage Levels
US National Differences (to be in
IEC 61010-1 3rd Edition the North American Harmonized
Standard)
33 V rms 30 V rms
46.7 V peak 42.4 V peak
70 V dc 60 V dc
3
4. Permissible Limits for Accessible Parts
Single Fault Condition (6.3.2) Continued
IEC 61010-1 3nd Edition National Differences
55 V rms 50 V rms
78 V peak 70 V peak
140 V dc 120 V dc
Note: Sub-clauses 6.3.2 A
4
5. Figure 2DV - Maximum duration of short-term ACCESSIBLE
voltages in SINGLE FAULT CONDITION (see 6.3.2 a))
Key
A a.c. voltage level in WET LOCATIONS C d.c. voltage level in WET LOCATIONS
B a.c. voltage level in dry locations D d.c. voltage level in dry locations
7. National Difference – Protective Conductor
Impedance Continued
• The test current is twice the rating of the attachment plug cap, but
not less than 40 A.
• If the equipment contains overcurrent protection devices for all poles
of the MAINS supply, and if the wiring on the supply side of the
overcurrent protection devices cannot become connected to
ACCESSIBLE conductive parts in the case of a single fault, the test
current need not be more than twice the RATED current of the
internal overcurrent protection devices.
• If the test current exceeds 500 A, see CSA 0.4.
7
9. National Difference – Protective Bonding
impedance Conformity Statement
6.5.2.5DV D2 Modification:
• IEC - Conformity is checked by applying a test current of twice the
value of the overcurrent protection means specified in the equipment
installation instructions for the building supply MAINS CIRCUIT for 1
min between the PROTECTIVE CONDUCTOR TERMINAL and
each ACCESSIBLE conductive part for which PROTECTIVE
BONDING is required. The voltage between them shall not exceed
10 V a.c. r.m.s. or d.c.
• In the first sentence of the conformity statement, replace “1 min” with
“the duration specified in Table 6.5.2.4DV.1”.
• In the second sentence of the conformity statement, replace “10 V”
with “4 V”.
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11. National Difference - Connection to the MAINS supply
source and connections between parts of equipment
Detachable MAINS supply cords with MAINS connectors according to IEC 60320 shall
either meet the requirements of IEC 60799, or shall be RATED at least for the current
RATING of the MAINS connector fitted to the cord.
ND - 6.10.1DV.3 Delete the reference to the requirements of IEC 60799 for
detachable MAINS supply cords in the sixth paragraph.
ND - 6.10.1DV.4 Add the following paragraphs and new note after the sixth
paragraph:
ND - Requirements for MAINS cords or cord sets are contained in ANSI/UL 817 and
CSA C22.2 No. 21.
ND - Requirements for general use receptacles, attachment plugs, and similar
wiring devices are contained in ANSI/UL 498 and CSA C22.2 No. 42, CSA C22.2 No.
182.1, CSA C22.2 No. 182.2, and CSA C22.2 No. 182.3.
ND - NOTE This subclause only applies to cords connected to the external fixed
MAINS socket-outlet and to external interconnecting mains cords. This subclause
does not apply to cords fully contained within the equipment enclosure
• Figure 9 explains the terminology for MAINS supply cords.
• Conformity is checked by inspection and, where necessary, by measurement.
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12. National Difference - 6.10.4DV.1 PERMANENTLY CONNECTED
EQUIPMENT
• Addition of a new clause
• Equipment intended for permanent connection to the MAINS
shall meet the requirements of Annex DVD.
• Conformity is checked as specified in Annex DVD.
13. National Difference – 6.11 Title Modification
• 6.11 Disconnection from supply source
• 6.11DV D2 Modification of the title: Add “and maintaining polarity” to
the end of the subclause title.
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14. National Difference – 6.11.5DV D2 Polarity of
MAINS Connections
ND - 6.11.5DV D2 Addition of a new sub-clause for Polarity of
Connections to the MAINS Circuit:
• Any line-connected single-pole switch, any center contact of a lamp
holder, and any automatic control with a marked off position shall be
connected to a TERMINAL or lead intended for connection to the
ungrounded conductor of the supply circuit.
NOTE An “ungrounded” supply conductor is one that is not
connected to protective earth at any point in the building installation.
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15. • National Difference – 9.6.1. ADV Connection
of overcurrent protective devices
Added the following for connections of overcurrent protective devices
• 9.6.1ADV.1 A single-pole circuit breaker must be connected to the
ungrounded supply conductor
• 9.6.1ADV.2 A multiple-pole circuit breaker must interrupt the neutral
(grounded) and ungrounded conductors simultaneously.
• 9.6.1ADV.3 A single fuse must be in the ungrounded conductor.
• 9.6.1ADV.4 Fuses used in both the neutral (grounded) and
ungrounded supply conductors must be adjacent with same ratings
and characteristics.
• 9.6.1ADV.5 Screw shell of a plug fuseholder and accessible contact
of an extractor type fuseholder when:
• Located in the Ungrounded supply conductor: shall be connected towards
the load.
• Located in the Neutral conductor: the shell shall be connected towards the
neutral supply line.
15
16. • National Difference – 11.7.1. DV max.
Pressure, referencing Annex G as normative
for certain types
• 11.7.1DV.1 Laboratory and Testing and Measurement equipment
having both of the following characteristics shall meet the
requirements of 11.7.2 and G.5:
a) a product of pressure and volume greater than 200 kPa·l,
b) a pressure .greater than 50 kPa.
• 11.7.1DV.2 Laboratory equipment and testing and measurement
equipment that do not have those characteristics shall meet the
requirements of 11.7.3 and 11.7.4, as applicable.
• 11.7.1DV.3 Process Control and other equipment shall meet the
requirements of Annex G, as applicable
16
17. • National Difference – Leakage and Rupture at
High Pressure11.7.2. DV Replacing Note as
follows:
• Fluid-containing parts which in NORMAL USE have both of the
following characteristics shall not cause a HAZARD through rupture
or leakage:
a) a product of pressure and volume greater than 200 kPa·l;
b) a pressure greater than 50 kPa.
Conformity is checked by inspection and, if a HAZARD could arise, by the
described hydraulic test
• NOTE National authorities may allow safety to be established by
calculation, for example according to the ASME Boiler and Pressure
Vessel Code.
17
18. National Difference – 14.1 Components and
Subassemblies North American Standards
• a) applicable safety requirements of a relevant IEC standard …
• b) the requirements of this standard and, where necessary for the
application, any additional applicable safety requirements of the
relevant IEC component standard, …
• c) if there is no relevant IEC standard, the requirements of this
standard;
• d) applicable safety requirements of a non-IEC standard which are at
least as high as those of the relevant IEC standard, provided that the
component has been approved to the non- IEC standard by a
recognized testing authority.
ND – In all these sub-clauses ), replace “IEC” with “ANSI, CAN, CSA,
IEC, ISO, or UL”.
ND - . Add a new note 3:
• NOTE 3: Annex DVA provides applicable safety requirements.
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19. National Difference – 14.7 Printed Wiring
Boards North American Flammability
Printed wiring boards shall be made of material with a flammability
classification of V-1 or better of IEC 60695-11-10.
ND - 14.7DV D2 Addition of the following to the end of the first
paragraph:
• A flammability RATING of ANSI/UL V-1 or CAN/CSA C22.2 No. 0.17
is considered equivalent to the same classification of IEC 60695-11-
10.
19
20. National Difference – 14.9 Outdoor Use
ND - 14.9DV D2 Add a new sub-clause to address enclosures intended
for outdoor use:
• Nonmetallic enclosures intended for outdoor use shall meet the UV
resistance requirements of ANSI/UL 746C or of CSA C22.2 No. 0.17,
or both as appropriate.
NOTE ANSI/UL 746C, clause 25, requires a 1 000 hour UV/water exposure
preconditioning using a xenon-arc or
• alternatively a 720 hour UV/water exposure preconditioning using
twin carbon arcs. CSA C22.2 No. 0.17, subclause 5.9, permits only
the 1 000 hour UV/water exposure preconditioning.
20
21. National Difference – 14.10 Conductive
Coatings
ND - 14.10DV D2 Add a new subclause to address conductive
coatings, shields, and tape:
• 14.10DV.1.1 The bond of a conductive (metallic) coating applied to a
polymeric part shall be evaluated.
• 14.10DV.1.2.
a) Evaluating the bond in accordance with the requirements for
“Adhesives” in ANSI/UL 746C and/or CSA C22.2 No. 0.17, or
b) Evaluating the product to determine that peeling or flaking of the
coating would not reduce spacings or bridge live parts so as to introduce a
risk of fire or electric shock.
.
21
22. National Difference – 14.10 Conductive Shields,
and Tape
14.10DV.2 Conductive shield or tape
• 14.10DV.2.1 If peeling of the conductive shield or tape may introduce
a RISK of fire or electric shock, the bond between a conductive
shield or tape and any other surface shall be investigated.
• 14.10DV.2.2 Conformity is checked by inspection
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23. National Difference – 14.11 Direct Plug-in
Transformers North America Standards
• ND - Add a new sub-clause14.11DV D2
• 14.11DV.1 Direct plug-in transformer units:
• Direct plug-in transformer units are subject to additional
requirements found in ANSI/UL 1310, CAN/CSA C22.2 No. 223,
ANSI/UL 60950-1, or CSA C22.2 No. 60950-1, as applicable.
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24. Measuring circuit TERMINALS
ND - Table 101DV DR Modify the values in Table 101 by replacing it with the
following:
Table 101DV - CLEARANCES and CREEPAGE DISTANCES for measuring circuit
TERMINALS with HAZARDOUS LIVE conductive parts (IEC Values in brackets)
Voltage on conductive parts of TERMINAL CLEARANCE and
CREEPAGE DISTANCE
V a.c. r.m.s. V d.c. mm
30 (33) 300 60 (70) 414 0,8
>300 600 >414 848 1,0
>600 1 000 >848 1 414 2,6
NOTE Values are determined by calculation for REINFORCED INSULATION. Transients are not taken into account.
Conformity is checked by inspection and measurement.
25. 101.3 Protection Against Mismatches of Inputs and
Ranges
ND - 101.3.3DV D2 Addition of the following test:
101.3.3DV.1 If the function or range controls have any effect on the
electrical characteristics of the input circuit, these controls shall
be changed to all possible settings while the input TERMINALS
are connected to the maximum RATED source.
26. Test leads for the tests of 101.3.2 and 101.3.3
101.3.4 …. If the manufacturer-supplied test leads are permanently
connected to the equipment, then the attached test leads supplied by
the manufacturer shall be used without modification.
ND - 101.3.4DV D2 Modification of 101.3.4 by deleting the following
paragraph
"If the manufacturer-supplied test leads are permanently
connected to the equipment, then the attached test leads
supplied by the manufacturer shall be used without
modification." and replacing it with the following:
101.3.4DV.1 The applicable tests of 101.3.2 and 101.3.3 shall be
performed with the test leads specified above and shall be
repeated with any test leads supplied with the equipment by
the manufacturer.
27. Annex DVA (informative) CSA, UL, IEC
component standards.
ND - DVA D2 Addition of a new annex DVA as follows:
• The following is a matrix that provides a cross-reference
between CSA, UL, and IEC standards for components.
• This cross-reference is not meant to imply that the standards
are equivalent. The CSA, UL, and IEC standards listed are used
for evaluation of components and features of products covered
by this standard.
• Components need only comply with the applicable component
standard acceptable in the country where the product is to be
used.
• These standards are considered to refer to the latest edition and
all revisions published to that edition.
30. Annex DVB (informative)
ND - DVB D2 Addition of a new annex DVB as follows
• A table indicating identifying all clauses that have a National
Difference
31. Annex DVC - (informative) - UV radiation limits: Guidelines from
the American Conference of Governmental Industrial Hygienists
(ACGIH)
• DVC D2 Addition of a new annex DVC for UV radiation limits
• DVC.1.1 These threshold limit values (TLVs) refer to ultraviolet (UV)
radiation in the spectral region between 180 and 400 nm and represent
conditions under which it is believed that nearly all workers may be
repeatedly exposed without adverse health effects.
• DVC.1.2 These values for exposure of the eye or the skin apply to UV
radiation from arc, gas, and vapor discharges, fluorescent and
incandescent sources, and solar radiation, but they do not apply to UV
lasers (see the TLV for lasers). These values do not apply to UV
radiation exposure of photosensitive individuals or of individuals
concomitantly exposed to photosensitizing agents. These exposures
to the eye do not apply to aphakics. (See light and near-infrared TLV for
radiation.) These values should be used as guides in the control of
exposure to continuous sources where the duration of exposure is not
less than 0,1 s. Likewise, these values should not be regarded as a fine
line between safe and dangerous levels.
32. Annex DVC - (informative) - UV radiation limits:Guidelines from
the American Conference of Governmental Industrial Hygienists
(ACGIH
• DVC.2 Recommended values
•
DVC.2.1 The TLVs for occupational exposure to UV radiation incident upon skin
or eye where irradiance values are known and exposure time is controlled are
as follows:
• a) UV-A (315 to 400 nm) radiation to the unprotected eye:
• 1) For exposure times less than 1 000 seconds, the total energy should not
exceed 1 J/cm2 (1 000 mJ/cm2).
• 2) For exposure times greater than 1 000 seconds, the average power level
should not exceed 1 mW/cm2; and no 1 000 second time period should present
a total energy that exceeds 1 J/cm2 (1 000 mJ/cm2).
• b) For monochromatic sources, the TLV for exposure to the unprotected skin
or eye is shown in Table DVC.2.1.1 (also represented in Figure DVC.2.1.1) and
should not be exceeded within an 8-hour period.
• c) For broad-spectrum or multi-peak sources, the TLV for exposure of the
unprotected skin or eye should be calculated based on an effective weighting
formula:
• Eeff = S (El • S l • Dl )
33. Annex DVD (normative) permanent connection
to MAINS
ND - DVD D2 Addition of a new Annex DVD as follows:
• DVD.1 General
• DVD.1.1 Equipment intended for permanent connection to the mains
shall have provision for connection of a wiring system in accordance
with ANSI/NFPA 70, NEC, with CSA C22.1, CEC, Part I, or with both as
appropriate, and shall meet the requirements of DVD.2 to DVD.3, as
applicable.
• DVD.1.2 Conformity is checked by inspection, and as specified in
DVD.2 to DVD.3.
34. Annex DVD (normative) permanent connection
to MAINS (Cont’d)
Topics Are:
DVD.2 Wiring TERMINALS and leads e.g.
• DVD.2.1.1 PERMANENTLY CONNECTED EQUIPMENT shall be provided
with TERMINALS or leads for the connection of conductors having an
ampacity that, in accordance with the National Electrical Code and/or the
Canadian Electrical Code, Part I, is acceptable for the equipment.
DVD.3 ENCLOSURE requirements for conduit entry e.g
• DVD.3.1 An ENCLOSURE shall not pull apart or sustain damage such as
cracking and breaking, and knockouts shall remain in place when
subjected to the pulling, torque, and bending that is likely to occur.
DVD.4 Conduit ENCLOSURE entry tests e.g.
• DVD.4.1 Conduit pull-out test
• DVD.4.2 Conduit torque test
• DVD.4.3 Bending
• DVD.4.4 Knockouts
35. Summary
National Differences for:
• Risk of Electric Shock
• Risk of Fire
• Protection Against Hazards from Fluids
• Components and Subassemblies
• Measuring Circuits
• Annexes
Slide 35