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 2014-08-02

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62A/1013/CDV

IEC 82304-1: Health Software - Part 1: General requirements for product safety
2015-07-312015-11-06yes
TC 66
TC 76
62A/1020/DA

Draft agenda for the meeting to be held in Kobe, Japan on 2015-11-10 (starting time: 13:00 to approximate finishing time: 17:00) and 2015-11-11 (Starting time: 09:00 to approximate finishing time: 12:00)
2015-07-24
62A/1021/INF

Results of 62A/991/DC - Review of IEC 60601-1, Ed. 3.1, Medical electrical equipment - Part 1: General requirements for safety and essential performance and Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-24
62A/1022/INF

Results of 62A/992/DC - Review of IEC 60601-1-2 Ed. 4.0, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests and Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-24
62A/1023/INF

Results of 62A/993/DC - Review of IEC 60601-1-6, Ed. 3.1, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability and Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-24
62A/1024/INF

Results of 62A/994/DC - Review of IEC 60601-1-8, Ed. 2.1, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems and Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-24
62A/1025/INF

Results of 62A/995/DC - Review of IEC 60601-1-9, Ed. 1.1, Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design and Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-24
62A/1026/INF

Results of 62A/996/DC - Review of IEC 60601-1-10, Ed. 1.1, 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 and Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-24
62A/1027/INF

Results of 62A/997/DC - Review 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 and Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-24
62A/1028/INF

Results of 62A/998/DC - Review of IEC 60601-1-12, Ed. 1.0, 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 and Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-24
62A/1029/CD

IEC TR 60601-4-1: Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
2015-07-242015-09-25?
TC 65
TC 66
TC 76
TC 108
62A/1030/Q

Questionnaire: IEC 60601-1, Ed. 3.1, Medical electrical equipment - Part 1: General requirements for safety and essential performance - Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-242015-10-02
62A/1031/Q

Questionnaire: IEC 60601-1-2 Ed. 4.0, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests - Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-242015-10-02
62A/1032/Q

Questionnaire: IEC 60601-1-6, Ed. 3.1, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability - Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-242015-10-02
62A/1033/Q

Questionnaire: IEC 60601-1-8, Ed. 2.1, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems - Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-242015-10-02
62A/1034/Q

Questionnaire: IEC 60601-1-9, Ed. 1.1, Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design - Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-242015-10-02
62A/1035/Q

Questionnaire: IEC 60601-1-10, Ed. 1.1, 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 - Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-242015-10-02
62A/1036/Q

Questionnaire: 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 - Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-242015-10-02
62A/1037/Q

Questionnaire: IEC 60601-1-12, Ed. 1.0, 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 - Question for Discussion at the Kobe Meeting of IEC/SC 62A
2015-07-242015-10-02
62A/1019/INF

Publication of 30+ ENs in the field of medical electrical equipment in May 2015
2015-07-17
62A/952A/CC

Revised compilation of comments on 62A/940/CD - IEC TR 80001-2-8: Application of risk management for IT networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
2015-06-26no
62A/1018/DTR

IEC TR 80001-2-8: Application of risk management for IT networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
2015-06-262015-08-28no
TC 65
TC 66
TC 76
TC 108
62A/1016/CD

ISO TR 80001-2: Medical device software - Part 2: Validation of software for regulated processes
2015-06-192015-08-21?
TC 65
TC 66
TC 76
TC 108
62A/1017/INF

ISO Preliminary Work Item to revise ISO/TR 11633-1
2015-06-19
62A/1015/DTR

IEC TR 62366-2: Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
2015-06-122015-08-14no
TC 66
TC 76
TC 108
62A/1006A/CC

Revised compilation of comments on 62A/986/CD - IEC TR 62366-2: Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
2015-05-29no
62A/1014/RVD

Report of voting on 62A/1007/FDIS - Amendment 1 to IEC 62304: Medical device software - Software life cycle processes
2015-05-29yes
62A/930B/CC

Revised compilation of comments on 62A/913/CD - IEC 82304-1: Health Software - Part 1: General requirements for product safety
2015-05-22yes
62A/1012/INF

Report of IEC/SC 62A-ISO/TC 215 Joint Working Group 7 May 2015
2015-05-15
62A/987A/CC

Revised compilation of comments on 62A/971/CD - IEC TR 60601-4-2: Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity, performance of medical electrical equipment and medical electrical systems
2015-05-08?
62A/1000A/INF

Amended report of comments and comments on 62A/979/DC: Health Software Ad hoc Group Draft Report - September 2014 / Health Software and Health IT Safety Standards / FUTURE STATE Architecture/Framework and Roadmap - DRAFT Report
2015-05-08
62A/1009/INF

Final report - Health Software Ad hoc Group Report - April 2015 - Health Software and Health IT Safety Standards - FUTURE STATE Architecture/Framework and Roadmap and Related actions taken at the April 2015 meeting of ISO/TC 215
2015-05-08
62A/1010/DC

Draft revision of ISO/IEC Guide 63 - Guide to the development and inclusion of aspects of safety in International Standards for medical devices
2015-05-082015-08-14
62A/1011/CD

IEC TR 60601-4-2: Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity; performance of medical electrical equipment and medical electrical systems
2015-05-082015-08-14?
TC 66
TC 76
TC 77
TC 108
62A/1008/RQ

Result of Questionnaire 62A/1005/Q: Proposal to publish guidance for writers of particular standards on creating alarm system related requirements as a technical report
2015-04-24
62A/1006/CC

Compilation of comments on 62A/986/CD - IEC TR 62366-2: Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
2015-03-20no
62A/1007/FDIS

Amendment 1 to IEC 62304: Medical device software - Software life cycle processes
2015-03-202015-05-22yesVoting Result
TC 66
TC 76
TC 108
62A/1005/Q

Proposal to publish guidance for writers of particular standards on creating alarm system related requirements as a technical report
2015-03-062015-04-17Report of Comments
62A/1000/INF

Report of comments and comments on 62A/979/DC: Health Software Ad hoc Group Draft Report - September 2014 / Health Software and Health IT Safety Standards / FUTURE STATE Architecture/Framework and Roadmap - DRAFT Report
2015-02-27
62A/1001/RQ

Results of Questionnaire 62A/985/Q: Proposal to limit the membership of IEC/SC 62A/MT 32 - Standardization of medical electrical equipment safety
2015-02-27
62A/1002/AC

ISO/TC 210-IEC/SC 62A JWG 1 - Call for experts
2015-02-27
62A/1003/AC

IEC/SC 62A MT 32 - Call for experts
2015-02-27
62A/1004/RVC

Result of voting on 62A/972/DTR - IEC TR 60878: Graphical symbols for electrical equipment in medical practice
2015-02-27no
62A/999/RVN

Result of voting on 62A/999/RVN: Application of risk management for IT networks incorporating medical devices - Part 2-x: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC/TR 80001-2-2 security capabilities
2015-02-20?
62A/989/INF

Result of comments and comments on 62A/958/DC - ISO/DIS 27799: Health informatics - Information security management in health using ISO/IEC 27002
2015-02-13
62A/990/INF

Report of comments and comments on 62A/974/DC: Request for comments from ISO/TC 215 on a New Work Item Proposal for a Technical Specification on "Framework of Event Data & Reporting Definitions for the Safety of Health Software"
2015-02-13
62A/991/DC

Systematic Review: IEC 60601-1, Ed. 3.1, Medical electrical equipment - Part 1: General requirements for safety and essential performance and the collateral standards under the jurisdiction of IEC/SC 62A that collectively form the "general standard"
2015-02-132015-05-08Report of Comments
62A/992/DC

Systematic Review: IEC 60601-1-2 Ed. 4.0, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests and Part 1 and the other collateral standards under the jurisdiction of IEC/SC 62A that collectively form the "general standard"
2015-02-132015-05-08Report of Comments
62A/993/DC

Systematic Review: IEC 60601-1-6, Ed. 3.1, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability and Part 1 and the other collateral standards under the jurisdiction ofIEC/SC 62A that collectively form the "general standard"
2015-02-132015-05-08Report of Comments
62A/994/DC

Systematic Review: IEC 60601-1-8, Ed. 2.1, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems and Part 1 and the other collateral standards under the jurisdiction of IEC/SC 62A that collectively form the "general standard"
2015-02-132015-05-08Report of Comments
62A/995/DC

Systematic Review: IEC 60601-1-9, Ed. 1.1, Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design and Part 1 and the other collateral standards under the jurisdiction of IEC/SC 62A that collectively form the "general standard"
2015-02-132015-05-08Report of Comments
62A/996/DC

Systematic Review: IEC 60601-1-10, Ed. 1.1, 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 and Part 1 and the other collateral standards under the jurisdiction of IEC/SC 62A that collectively form the "general standard"
2015-02-132015-05-08Report of Comments
62A/997/DC

Systematic Review: 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 and Part 1 and the other collateral standards under the jurisdiction of IEC/SC 62A that collectively form the "general standard"
2015-02-132015-05-08Report of Comments
62A/998/DC

Sytematic Review: IEC 60601-1-12, Ed. 1.0, 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 and Part 1 and the other collateral standards under the jurisdiction of IEC/SC 62A that collectively form the "general standard"
2015-02-132015-05-08Report of Comments
62A/988/RVD

Report of Voting on 62A/977/FDIS - IEC 62366-1: Medical devices - Part 1: Application of usability engineering to medical devices
2015-02-06yes
62A/973A/RVC

Revised result of voting on 62A/951/DTR - 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
2015-01-30no
62A/987/CC

Compilation of comments on 62A/971/CD - IEC TR 60601-4-2: Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity; performance of medical electrical equipment and medical electrical systems
2015-01-16?
62A/982/RR

Review report of IEC 60601-1-8 Ed.2.0: Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
2015-01-09
62A/983/RR

Review report of IEC TR 60513 Ed.2.0: Fundamental aspects of safety standards for medical electrical equipment
2015-01-09no
62A/984/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
2015-01-09
62A/985/Q

Proposal to limit the membership of IEC/SC 62A/MT 32 - Standardization of medical electrical equipment safety
2015-01-092015-02-20Report of Comments
62A/986/CD

IEC TR 62366-2: Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
2015-01-092015-03-13noReport of Comments
TC 22
TC 66
TC 76
TC 108
62A/948A/RVC

Revised result of voting on 62A/925/CDV - Amendment 1 to IEC 62304: Medical device software - Software life cycle processes
2014-12-19yes
62A/979/DC

Health Software Ad hoc Group Draft Report - September 2014 Health Software and Health IT Safety Standards - FUTURE STATE Architecture/Framework and Roadmap - DRAFT Report
2014-12-192015-02-20Report of Comments
62A/980/RM

Unconfirmed minutes of the meeting held in New Orleans, Louisiana, USA on 24 November 2014
2014-12-19
62A/981/INF

Maintenance Cycle - As approved by IEC/SC 62A in New Orleans (see 62A/980/RM)
2014-12-19
62A/978/RVD

Report of Voting on 62A/959/FDIS - 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
2014-12-12yes
62A/977/FDIS

IEC 62366-1: Medical devices - Part 1: Application of usability engineering to medical devices
2014-11-282015-01-30yesVoting Result
TC 66
TC 76
62A/968B/INF

Revised IEC/SC 62A Liaison reports (Agenda item 9.1)
2014-11-14
62A/976/INF

Results of document for comment 62A/962/DC - Periodic review of documents under the jurisdiction of Subcommittee 62A
2014-11-14
62A/960A/INF

Revised result of the Call for Experts for IEC/SC 62A-ISO/TC 215 JWG 7: Project IEC 62304 Ed. 2.0
2014-11-07
62A/974/DC

Request for comments from ISO/TC 215 on a New Work Item Proposal for a Technical Specification on "Framework of Event Data & Reporting Definitions for the Safety of Health Software"
2014-11-072015-02-06Report of Comments
62A/975/NP

Application of risk management for IT networks incorporating medical devices - Part 2-x: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC/TR 80001-2-2 security capabilities
2014-11-072015-02-13?Voting Result
62A/973/RVC

Result of voting on 62A/951/DTR - 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
2014-10-31no
62A/949A/DA

Revised draft agenda for the meeting to be held in New Orleans, Louisiana, USA on 2014-11-24 (starting time: 09:00) to (approximate finishing time: 12:00)
2014-10-24
62A/967A/INF

Updated reports from the working groups, maintenance teams and joint working groups of IEC/SC 62A (Agenda item 5.2)
2014-10-24
62A/968A/INF

Updated IEC/SC 62A Liaison reports (Agenda item 9.1)
2014-10-24
62A/969/INF

Secretariat's view of the programme of work of the subcommittee (Agenda item 8.1)
2014-10-24
62A/970/PW

Programme of work of the subcommittee as recorded by IEC Central Office in its database
2014-10-24
62A/971/CD

IEC TR 60601-4-2: Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity; performance of medical electrical equipment and medical electrical systems
2014-10-242015-01-09?Report of Comments
TC 66
TC 76
TC 108
62A/972/DTR

IEC TR 60878: Graphical symbols for electrical equipment in medical practice
2014-10-242015-01-09noVoting Result
TC 66
TC 76
TC 108
62A/939A/CC

Revised compilation of comments on 62A/926/CD - IEC TR 60878: Graphical symbols for electrical equipment in medical practice
2014-10-17no
62A/966/INF

Report of the Secretariat (Agenda item 5.1)
2014-10-10
62A/967/INF

Reports from the working groups, maintenance teams and joint working groups of IEC/SC 62A (Agenda item 5.2)
2014-10-10
62A/968/INF

IEC/SC 62A Liaison reports (Agenda item 9.1)
2014-10-10
62A/963/INF

Confirmation of working group conveners (Agenda Item 5.1.1)
2014-10-03
62A/964/INF

Subcommittee 62A Liaison List
2014-10-03
62A/965/INF

Maintenance Cycle (Agenda item 7.1)
2014-10-03
62A/959/FDIS

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
2014-09-262014-11-28yesVoting Result
TC 66
TC 76
62A/960/INF

Result of the Call for Experts for IEC/SC 62A-ISO/TC 215 JWG 7: Project IEC 62304 Ed. 2.0
2014-09-26
62A/961/INF

Health Software Ad hoc group Draft Report - September 2014 Health Software and Health IT Safety Standards FUTURE STATE Architecture/Framework and Roadmap - DRAFT Report
2014-09-26
62A/962/DC

Periodic review of documents under the jurisdiction ofSubcommittee 62A
2014-09-262014-11-07Report of Comments
62A/955/RVC

Result of voting on 62A/943/DTR - 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
2014-09-19no
62A/956/RVC

Result of voting on 62A/945/DTR - 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
2014-09-19no
62A/957/INF

Report of comments and comments on 62A/950/DC: Appointment of an IEC Co-convener for IEC/SC 62A-ISO/TC 210 JWG 4, Medical devices - General requirements for safety and essential performance - Usability
2014-09-19
62A/958/DC

ISO/DIS 27799: Health informatics - Information security management in health using ISO/IEC 27002
2014-09-192015-02-06Report of Comments
62A/954/RQ

Result of questionnaire 62A/944/Q: Proposal to modify the scope of IEC/SC 62A ISO/TC 215 Joint Working Group (JWG) 7, Application of risk management to information technology (IT) networks incorporating medical devices
2014-09-05
62A/953/RVD

Report of Voting on 62A/942/FDIS - Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
2014-08-22yes
62A/951/DTR

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
2014-08-152014-10-17noVoting Result
TC 66
TC 76
TC 108
62A/952/CC

Compilation of comments on 62A/940/CD - IEC TR 80001-2-8: Application of risk management for IT networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
2014-08-15no