International Standards and Conformity Assessment for all electrical, electronic and related technologies

SC 62A

Common aspects of electrical equipment used in medical practice

 
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SC 62A Working Documents since 2013-04-16

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62A/935/CC

Compilation of comments on 62A/919/CD - IEC TR 60601-4-3: Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unclear or unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements
2014-04-04?
62A/930A/CC

Revised compilation of comments on 62A/913/CD - IEC 82304-1: Health Software - Part 1: General requirements for product safety
2014-03-28?
62A/932/FDIS

IEC 60601-1-12: Part 1-12: Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
2014-03-282014-05-30yes
TC 66
TC 76
62A/933/RVC

Result of voting on 62A/900A/CDV - IEC 62366-1: Medical devices - Part 1: Application of usability engineering to medical devices
2014-03-28yes
62A/934/CC

Compilation of comments on 62A/923/CD - ISO TR 80001-2-7: Application of risk management for IT-networks incorporating medical devices - Application guidance - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
2014-03-28?
62A/931/CC

Compilation of comments on 62A/917/CD - IEC TR 80001-2-5: Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
2014-03-21?
62A/929/RVN

Result of voting on 62A/915/NP: Application of risk management for IT-networks incorporating medical devices Part 2-x: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
2014-03-14?
62A/930/CC

Compilation of comments on 62A/913/CD - IEC 82304-1: Health Software - Part 1: General requirements for product safety
2014-03-14?
62A/922A/CDV

IEC 60601-1-11: Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
2014-03-072014-05-30yes
TC 66
TC 76
62A/928/RVC

Result of voting on 62A/918/DTR - IEC/TR 80002-3: Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
2014-03-07no
62A/922/CDV

Withdrawn
2014-02-28yes
TC 66
TC 76
62A/927/RVC

Result of voting on 62A/859/DTR - ISO/DTR 17791: Guidance on Standards for Enabling Safety in Health Software
2014-02-28no
62A/910A/CC

Revised compilation of comments on 62A/886/CD - Amendment 1 to IEC 62304: Medical device software - Software life cycle processes
2014-02-21yes
62A/926/CD

IEC/TR 60878: Graphical symbols for electrical equipment in medical practice
2014-02-212014-05-23no
TC 66
TC 76
62A/924/RVD

Report of Voting on 62A/916/FDIS: IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
2014-02-07yes
62A/894A/RVC

Revised result of voting on 62A/863/CDV - IEC 62353: Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
2014-01-24yes
62A/923/CD

Application of risk management for IT-networks incorporating medical devices - Application guidance - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
2014-01-172014-03-21?Report of Comments
TC 66
TC 76
62A/900A/CDV

IEC 62366-1: Medical devices - Part 1: Application of usability engineering to medical devices
2014-01-102014-03-21yesVoting Result
TC 66
TC 76
62A/900/CDV

Withdrawn
2013-12-20yes
TC 66
TC 76
62A/919/CD

IEC/TR 60601-4-3: Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unclear or unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements
2013-12-202014-03-21?Report of Comments
TC 66
TC 76
62A/920/RQ

Report of questionnaire 62A/902/Q: Proposal to advance the Working Draft of IEC 60601-1-11 Ed. 2.0: Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment to the Enquiry (CDV) Stage
2013-12-20
62A/921/RR

Review report of IEC 60601-1-11 Ed.1.0: Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
2013-12-20yes
62A/847A/RVN

Revised result of voting on 62A/816/NP - IEC/TR 80001-2-5: Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance Guidance on distributed alarm systems
2013-12-13?
62A/917/CD

IEC/TR 80001-2-5: Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
2013-12-132014-03-14?Report of Comments
TC 66
TC 76
62A/918/DTR

IEC/TR 80002-3: Medical device software - Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
2013-12-132014-02-14noVoting Result
TC 66
TC 76
62A/897A/RVD

Revised report of Voting on 62A/889/FDIS - Amendement 1 à la CEI 62366 : Dispositifs médicaux - Application de l'ingénierie de l'aptitude à l'utilisation aux dispositifs médicaux
2013-12-06yes
62A/901A/RVN

Revised result of voting on 62A/901/NP: Medical electrical equipment - Part 4-x: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
2013-11-29?
62A/916/FDIS

IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
2013-11-292014-01-31yesVoting Result
TC 66
TC 76
62A/855A/CC

Revised compilation of comments on 62A/839/CD - IEC 82304-1: Health Software - Part 1: General requirements for product safety
2013-11-22?
62A/913/CD

IEC 82304-1: Health Software - Part 1: General requirements for product safety
2013-11-222014-02-28?Report of Comments
TC 66
TC 76
62A/914/INF

Supplemental Informative Document to Accompany ISO-IEC New Work Proposal to Develop IEC 80001-2-X, Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2 (62A/915/NP)
2013-11-22
62A/915/NP

IEC 80001-2-x, Application of risk management for IT networks incorporating medical devices - Part 2-X: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
2013-11-222014-02-28?Voting Result
62A/896A/RVD

Revised report of voting on 62A/888/FDIS - Amendment 1 to IEC 60601-1-10: Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
2013-11-15yes
62A/912/RVC

Result of voting on 62A/981/DTR - ISO/TR 80001-2-6: Application of risk management for IT-networks incorporating medical device - Part 2-6: Application guidance - Guidance for responsibility agreements
2013-11-15no
62A/910/CC

Compilation of comments on 62A/886/CD - Amendment 1 to IEC 62304: Medical device software - Software life cycle processes
2013-11-01yes
62A/911/RR

Review report of IEC/TR 62354 Ed.1.0: General testing procedures for medical electrical equipment
2013-11-01no
62A/903/INF

Result of document for comment 62A/893/DC: Periodic review of documents under the jurisdiction of Subcommittee 62A
2013-10-25
62A/904/RR

Review report of IEC/TR 60513 Ed.2.0: Fundamental aspects of safety standards for medical electrical equipment
2013-10-25
62A/905/RR

Review report of IEC/TR 60878 Ed.2.0: Graphical symbols for electrical equipment in medical practice
2013-10-25no
62A/906/RR

Review report of IEC/TR 60930 Ed.2.0: Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems
2013-10-25
62A/907/RR

Review report of IEC/TR 61258: Guidelines for the development and use of medical electrical equipment educational materials
2013-10-25
62A/908/RR

Review report of IEC 80001-1 Ed.1.0: Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
2013-10-25
62A/909/RR

Review report of IEC/TR 80002-1 Ed.1.0: Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
2013-10-25
62A/902/Q

Proposal to advance the Working Draft of IEC 60601-1-11 Ed. 2.0 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment to the Enquiry (CDV) Stage
2013-10-182013-11-29Report of Comments
62A/887A/RVC

Revised result of voting on 62A/850/CDV - IEC 60601-1-12: Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
2013-10-11yes
62A/899/CC

Compilation of comments on 62A/884A/CD - IEC 62366-1: Medical devices - Part 1: Application of usability engineering to medical devices
2013-10-11yes
62A/901/RVN

Result of voting on 62A/901/NP: Medical electrical equipment - Part 4-x: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
2013-10-11?
62A/896/RVD

Report of voting on 62A/888/FDIS - Amendment 1 to IEC 60601-1-10: Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
2013-09-20yes
62A/897/RVD

Report of Voting on 62A/889/FDIS - IEC 62366 am1 Ed. 1.0 Amendment 1 to IEC 62366: Medical devices - Application of usability engineering to medical devices
2013-09-20yes
62A/898/RVD

Report of Voting on 62A/890/FDIS - IEC 60601-1-6 am1 Ed. 3.0 Amendment 1 to IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: General requirement for basic safety and essential performance - Collateral standard: Usability
2013-09-20yes
62A/893/DC

Periodic review of documents under the jurisdiction of Subcommittee 62A
2013-08-162013-09-27Report of Comments
62A/894/RVC

Result of voting on 62A/863/CDV - IEC 62353: Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
2013-08-16yes
62A/895/INF

Proposed Procedure for ensuring coherence of the general and collateral standards in support of having undated references within IEC SC 62D particular standards (REVISED)
2013-08-16
62A/892/RQ

Result of questionnaire 62A/882/Q: Proposal to publish guidance on electromagnetic compatibility (EMC performance) as a technical report or to retain it as an informative annex in IEC 60601-1-2
2013-08-09
62A/891/DTR

ISO/TR 80001-2-6: Application of risk management for IT-networks incorporating medical device - Part 2-6: Application guidance - Guidance for responsibility agreements
2013-07-192013-09-20noVoting Result
TC 66
TC 76
TC 108
62A/884A/CD

IEC 62366-1: Medical devices - Part 1: Application of usability engineering to medical devices
2013-07-122013-09-06yesReport of Comments
TC 66
TC 76
TC 108
62A/888/FDIS

Amendment 1 to IEC 60601-1-10: Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
2013-07-122013-09-13yesVoting Result
TC 66
TC 76
62A/889/FDIS

Amendment 1 to IEC 62366: Medical devices - Application of usability engineering to medical devices
2013-07-122013-09-13yesVoting Result
TC 66
TC 76
62A/890/FDIS

Amendment 1 to IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: General requirement for basic safety and essential performance - Collateral standard: Usability
2013-07-122013-09-13yesVoting Result
TC 66
TC 76
62A/854A/CC

Revised compilation of ocmments on 62A/838/CD - IEC 62304: Medical device software - Software life cycle processes
2013-07-05yes
62A/885/RR

Review report of IEC 62304 Ed.1.0: Medical device software - Software life cycle processes
2013-07-05yes
62A/886/CD

Amendment 1 to IEC 62304: Medical device software - Software life cycle processes
2013-07-052013-10-11yesReport of Comments
TC 66
TC 76
TC 108
62A/887/RVC

Result of voting on 62A/850/CDV - IEC 60601-1-12: Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
2013-07-05yes
62A/872A/CC

Revised compilation of comments on 62A/844/CD - IEC 62366-1: Medical devices - Part 1: Application of usability engineering to medical devices
2013-06-28yes
62A/884/CD

Withdrawn
2013-06-28yes
TC 66
TC 76
TC 108
62A/883/INF

Subcommittee 62A Liaison List
2013-06-21
62A/832A/RVC

Revised result of voting on 62A/801A/CDV - IEC 60601-1-2: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
2013-06-14yes
62A/882/Q

Proposal to publish guidance on electromagnetic compatibility (EMC performance) as a technical report or to retain it as an informative annex in IEC 60601-1-2
2013-06-142013-07-26Report of Comments
62A/879A/RVN

Result of voting on 62A/856/NP - ISO/TR 80001-2-7: Application of risk management for IT-networks incorporating medical devices - Part 2-7: Application Guidance - Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
2013-06-07?
62A/881/RVD

Report of Voting on 62A/874/FDIS - Amendment 1 to IEC 60601-1-9: Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design
2013-05-31yes
62A/880/NP

Medical electrical equipment - Part 4-x: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
2013-05-172013-09-06?Voting Result
62A/879/RVN

Result of voting on 62A/856/NP - ISO/TR 80001-2-7: Application of risk management for IT-networks incorporating medical devices - Part 2-7: Application Guidance - Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
2013-05-10?
62A/863/CDV

IEC 62353: Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
2013-05-032013-08-09yesVoting Result
TC 66
TC 76
62A/878/RR

Review report of IEC 60601-1-1: Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
2013-05-03
62A/853B/RVC

Revised result of voting on 62A/826/CDV - Amendment 1 to IEC 62366: Medical devices - Application of usability engineering to medical devices
2013-04-26yes
62A/877/RM

Unconfirmed report of the meeting held in Shanghai, China on 17 April 2013
2013-04-26
62A/853A/RVC

Revised result of voting on 62A/826/CDV - Amendment 1 to IEC 62366: Medical devices - Application of usability engineering to medical devices
2013-04-19yes
62A/868B/INF

IEC/SC 62A Revised liaison reports - For the April 2013 Subcommittee meeting in Shanghai, China (Agenda item 8.1)
2013-04-19
62A/869A/INF

Revised report of the Secretariat: Covering activities of the Secretariat since the Nuremburg meeting (2011-09-21) - Report as of 22 February 2013 - For the April 2013 Subcommittee meeting in Shanghai, China (Agenda item 5.1)
2013-04-19
62A/876/INF

Subcommittee 62A Liaison List
2013-04-19