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 2013-10-26

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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?
TC 66
TC 76
TC 108
62A/972/DTR

IEC TR 60878: Graphical symbols for electrical equipment in medical practice
2014-10-242015-01-09no
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
2014-09-262014-11-28yes
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
2014-09-262014-11-07
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
2014-09-192015-02-06
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
2014-08-15?
62A/950/DC

Co-convenership of IEC/SC 62A-ISO/TC 210 JWG 4, Medical devices - General requirements for safety and essential performance - Usability
2014-08-012014-09-12Report of Comments
62A/948/RVC

Result of voting on 62A/925/CDV - Amendment 1 to IEC 62304: Medical device software - Software life cycle processes
2014-07-25yes
62A/949/DA

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)
2014-07-25
62A/947/RVC

Result of voting on 62A/936/DTR - IEC TR 62354: General testing procedures for medical electrical equipment
2014-07-11no
62A/933A/RVC

Revised result of voting on 62A/900A/CDV - IEC 62366-1: Medical devices - Part 1: Application of usability engineering to medical devices
2014-07-04yes
62A/945/DTR

ISO TR 80001-2-7: Application of risk management for IT-networks incorporating medical - Application guidance - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
2014-07-042014-09-05noVoting Result
TC 66
TC 76
TC 108
62A/946/AC

IEC/SC 62A-ISO/TC 215 JWG 7: IEC 62304 Ed. 2.0 - Call for experts
2014-07-04
62A/934A/CC

Revised 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
2014-06-27no
62A/935A/CC

Revised 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
2014-06-27no
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
2014-06-272014-08-15Report of Comments
62A/941A/RVC

Result of voting on 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
2014-06-20yes
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
2014-06-202014-09-05noVoting Result
TC 66
TC 108
62A/942/FDIS

IEC 62353: Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment
2014-06-132014-08-15yesVoting Result
TC 66
TC 76
62A/929A/RVN

Revised 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
2014-06-06?
62A/938/RVD

Report of Voting on 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
2014-06-06yes
62A/939/CC

Compilation of comments on 62A/926/CD - IEC TR 60878: Graphical symbols for electrical equipment in medical practice
2014-06-06no
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
2014-06-062014-08-08?Report of Comments
TC 66
TC 76
TC 108
62A/941/RVC

Result of voting on 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
2014-06-06yes
62A/931A/CC

Revised 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
2014-05-30no
62A/925F/CDV

2014-05-16yes
TC 66
TC 76
TC 108
62A/937/INF

Health Software Ad hoc group Interim Report - May 2014 Health Software Safety Standards / Future State Architecture/Framework - Discussion draft
2014-05-16
TC 66
TC 76
62A/936/DTR

IEC TR 62354: General testing procedures for medical electrical equipment
2014-05-022014-07-04noVoting Result
TC 66
TC 76
62A/925/CDV

Amendment 1 to IEC 62304: Medical device software - Software life cycle processes
2014-04-182014-07-18yesVoting Result
TC 66
TC 76
TC 108
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
2014-04-04no
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
2014-03-282014-05-30yesVoting Result
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
2014-03-28no
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
2014-03-21no
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
2014-03-072014-05-30yesVoting Result
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
2014-02-212014-05-23noReport of Comments
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
2014-01-172014-03-21noReport 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
2013-12-202014-03-21noReport 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
2013-12-13no
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
2013-12-132014-03-14noReport 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