International
Electrotechnical
Commission
International Standards and Conformity Assessment
for all electrical, electronic and related technologies
SC 62A |
Common aspects of electrical equipment used in medical practice |
SC 62A Working Documents since 2012-04-05
  Reference, Title | Downloads | Circulation Date | Closing Date | CENELEC | Voting / Comment | Authorized Committees |
|---|---|---|---|---|---|---|
62A/850/CDVIEC 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 | 2013-03-22 | 2013-06-28 | yes | TC 66 TC 76 | ||
62A/874/FDISAmendment 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 | 2013-03-22 | 2013-05-24 | yes | TC 66 TC 76 | ||
62A/857B/RVCRevised result of voting on 62A/840/DTR - ISO/TR 24971: Guidance on the application of ISO 14971 | 2013-03-22 | no | ||||
62A/873/RVNResult of voting on 62A/843/NP - ISO/TR 80001-2-6: Application of risk management for IT-networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements | 2013-03-15 | ? | ||||
62A/870/INFSecretariat's view of the programme of work of the subcommittee | 2013-03-08 | |||||
62A/871/PWProgramme of work of the Subcommittee as recorded by the IEC Central Office in its database | 2013-03-08 | |||||
62A/872/CCCompilation of comments on 62A/844/CD - IEC 62366-1: Medical devices - Part 1: Application of usability engineering to medical devices | 2013-03-08 | yes | ||||
62A/849A/DARevised draft agenda for the meeting to be held in Shanghai, China on 2013-04-17 (starting time: 09:00) to (approximate finishing time: 12:00)
| 2013-03-08 | |||||
62A/861/INFIEC/SC 62A Secretariat Plan for Updating the IEC 60601 Collateral Standards | 2013-02-22 | |||||
62A/862/INFSubcommittee 62A Liaison Liste (as for 2013-02-18) | 2013-02-22 | |||||
62A/864/INFProposed Procedure for ensuring coherence of the general and collateral standards in support of having undated references within IEC SC 62D particular standards - For the April 2013 Subcommittee meeting in Shangai, China (Agenda item 9.1)
| 2013-02-22 | |||||
62A/865/INFRecommendations by the Ad Hoc Group on Symbols for consideration by ISO/TC 210 and IEC/SC 62A - For the April 2013 Subcommittee meeting in Shangai, China (Agenda item 7.1)
| 2013-02-22 | |||||
62A/866/INFMaintenance Cycle - For the April 2013 Subcommittee meeting in Shanghai, China (Agenda item 6.3) | 2013-02-22 | |||||
62A/867/INFChairman's Proposal to establish a formal liaison with IEC/TC 108 - For the April 2013 Subcommittee meeting in Shanghai, China (Agenda item 8.3) | 2013-02-22 | |||||
62A/868/INFIEC/SC 62A Liaison reports - For the April 2013 Subcommittee meeting in Shanghai, China (Agenda item 8.1) | 2013-02-22 | |||||
62A/869/INFReport 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)
| 2013-02-22 | |||||
62A/808A/CCRevised compilation of comments on 62A/798/CD - IEC 62353: Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment | 2013-02-22 | yes | ||||
62A/860/INFReports from the working groups, maintenance teams and joint working groups of IEC/SC 62A - For the April 2013 Subcommittee meeting in Shanghai, China
| 2013-02-15 | |||||
62A/858/ISHInterpretation sheet for the publication IEC 60601-1:2005 and IEC 60601-1:2005 + A1:2012 (Editions 3 - 2005 and 3.1 - 2012) - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | 2013-02-01 | 2013-04-05 | ? | TC 66 TC 76 | ||
62A/859/DTRISO/TR 17791: Health informatics - Guidance on standards for enabling safety in health software | 2013-02-01 | 2013-04-05 | no | TC 66 TC 76 | ||
62A/857A/RVCRevised result of voting on 62A/840/DTR - ISO/TR 24971: Guidance on the application of ISO 14971 | 2013-02-01 | no | ||||
62A/855/CCCompilation of comments on 62A/839/CD - IEC 82304-1: Health Software - Part 1: General requirements for product safety | 2013-01-25 | ? | ||||
62A/856/NPISO/TR 80001-2-x: Application of risk management for IT-networks incorporating medical devices - Part 2-x: Application Guidance - Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1 | 2013-01-25 | 2013-04-26 | ? | |||
62A/857/RVCResult of voting on 62A/840/DTR - ISO/TR 24971: Guidance on the application of ISO 14971 | 2013-01-25 | no | ||||
62A/851/RVCResult of voting on 62A/822/CDV - 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 | 2013-01-18 | yes | ||||
62A/852/RVCResult of voting on 62A/827/CDV - 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 | 2013-01-18 | yes | ||||
62A/853/RVCResult of voting on 62A/826/CDV - Amendment 1 to IEC 62366: Medical devices - Application of usability engineering to medical devices | 2013-01-18 | yes | ||||
62A/854/CCCompilation of ocmments on 62A/838/CD - IEC 62304: Medical device software - Software life cycle processes | 2013-01-18 | yes | ||||
62A/819A/RVCRevised result of voting on 62A/796/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 | 2013-01-11 | yes | ||||
62A/849/DADraft agenda for the meeting to be held in Shanghai, China
on 2013-04-17 (starting time: 09:00) to (approximate finishing time: 12:00)
| 2012-12-21 | |||||
62A/845/INFResults of document for comments 62A/834A/DC - Periodic review of documents under the jurisdiction of Subcommittee 62A: IEC 60601-1-1, Ed. 2 (2000-12-14), Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
| 2012-12-07 | |||||
62A/846/INFResults of document for comment 62A/834A/DC - Periodic review of documents under the jurisdiction of Subcommittee 62A: IEC 60601-1-4, Ed. 1.0 (1996-05-31) / IEC 60601-1-4-am1 Ed. 1.0 (1999-10-29), Medical electrical equipment - Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems
| 2012-12-07 | |||||
62A/847/RVNResult 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 | 2012-12-07 | ? | ||||
62A/848/INFResult of document for comments 62A/836/DC: Proposal for an Interpretation Sheet for IEC 60601-1: 2005+A1: 2012 | 2012-12-07 | |||||
62A/844/CDIEC 62366-1: Medical devices - Part 1: Application of usability engineering to medical devices | 2012-11-23 | 2013-03-01 | yes | Report of Comments | TC 66 TC 76 | |
62A/843/NPISO/TR 80001-2-x: Application of risk management for IT-networks incorporating medical devices - Part 2-x Guidance for responsibility agreements | 2012-11-09 | 2013-02-15 | ? | Voting Result | ||
62A/842/RVCResult of voting on 62A/814/CDV - Amendment 1 to IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral Standard: Usability | 2012-11-02 | yes | ||||
62A/838/CDIEC 62304: Medical device software - Software life cycle processes | 2012-10-26 | 2013-01-11 | yes | Report of Comments | TC 66 TC 76 | |
62A/839/CDIEC 82304-1: Health Software - Part 1: General requirements for product safety | 2012-10-26 | 2013-01-11 | ? | Report of Comments | TC 66 TC 76 | |
62A/840/DTRISO/TR 24971: Guidance on the application of ISO 14971 | 2012-10-26 | 2013-01-11 | no | Voting Result | TC 66 TC 76 | |
62A/841/RVCResult of voting on 62A/831/DTR - IEC/TR 62348: Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of the IEC 60601-1:2005 to the previous edition | 2012-10-26 | no | ||||
62A/751B/RVNRevised result of voting on 62A/732/NP: New Work Item proposal on Healthcare Software Systems - Part 1: General requirements | 2012-10-26 | ? | ||||
62A/837/RVDReport of Voting on 62A/824/FDIS - Amendment 1 to IEC 60601-1-8:
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
| 2012-10-19 | yes | ||||
62A/833A/CCCompilation of comments on 62A/809/CD - ISO/TR 24971: Guidance on the application of ISO 14971 | 2012-10-19 | no | ||||
62A/835/RVCResult of voting on 62A/818/DTR - IEC/TR 80001-2-4: Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for Healthcare Delivery Organizations | 2012-10-12 | ? | ||||
62A/836/DCProposal for an Interpretation Sheet for IEC 60601-: 2005+A1: 2012
| 2012-10-12 | 2012-11-23 | Report of Comments | |||
62A/822/CDVAmendment 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 | 2012-09-28 | 2013-01-11 | yes | Voting Result | TC 66 TC 76 | |
62A/826/CDVAmendment 1 to IEC 62366: Medical devices - Application of usability engineering to medical devices | 2012-09-28 | 2013-01-11 | yes | Voting Result | TC 66 TC 76 | |
62A/827/CDVAmendment 1to 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 | 2012-09-28 | 2013-01-11 | yes | Voting Result | TC 66 TC 76 | |
62A/834A/DCRevised periodic review of documents under the jurisdiction of
Subcommittee 62A.
(The title in table 1 has been corrected) | 2012-09-28 | 2012-11-09 | Report of Comments | |||
62A/833/CCCompilation of comments on 62A/809/CD - ISO/TR 24971: Guidance on the application of ISO 14971 | 2012-09-14 | no | ||||
62A/834/DCPeriodic review of documents under the jurisdiction of
Subcommittee 62A | 2012-09-14 | |||||
62A/832/RVCResult 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 | 2012-08-31 | yes | ||||
62A/829/RQResult of questionnaire 62A/815/Q: Proposal to repurpose IEC/TR 62348 to provide an Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 | 2012-08-17 | |||||
62A/830/RRReview report of IEC/TR 62348: Mapping between the clauses of the third edition of IEC 60601-1 and the 1988 edition as amended | 2012-08-17 | no | ||||
62A/831/DTRIEC/TR 62348: Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of the IEC 60601-1:2005 to the previous edition | 2012-08-17 | 2012-10-19 | no | Voting Result | TC 66 TC 76 | |
62A/828/INFResults of document for comments 62A/813/DC - ISO/TR 17791: Health informatics - Guidance on standards for enabling safety in health software | 2012-08-03 | |||||
62A/824/FDISAmendment 1 to IEC 60601-1-8: 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
| 2012-07-27 | 2012-09-28 | yes | Voting Result | TC 66 TC 76 | |
62A/825/RRReview report of IEC 62366: Medical devices - Application of usability engineering to medical devices | 2012-07-27 | yes | ||||
62A/810A/INFAmended results of 62A/799/DC: Proposal to initiate a fast-track amendment to IEC 62366:2007, Medical devices - Application of usability engineering
| 2012-07-27 | |||||
62A/821/RRReview Report of 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 | 2012-07-20 | yes | ||||
62A/823/RRReview report of 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 | 2012-07-20 | yes | ||||
62A/820/RVDReport of Voting on 62A/805/FDIS - Amendment 1 to IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
| 2012-07-06 | yes | ||||
62A/819/RVCResult of voting on 62A/796/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 | 2012-06-22 | yes | ||||
62A/818/DTRIEC/TR 80001-2-4: Application of risk management forIT-networks incorporating medical devices - Part 2-4: General implementation guidance for Healthcare Delivery Organizations | 2012-06-08 | 2012-08-10 | ? | Voting Result | TC 66 TC 76 | |
62A/788A/RVNAmended results of voting on 62A/760/NP: Application of risk management for IT-networks incorporating medical devices - Part
2-4: General implementation guidance for Healthcare Delivery Organizations | 2012-06-08 | ? | ||||
62A/817/INFResults of 62/246/Q: Questionnaire on the proposal of the Secretariats of IEC/TC 62 and its subcommittees to initiate early maintenance on several Collateral Standards in the IEC 60601 Series | 2012-06-01 | |||||
62A/811/INFImplementation of EN 62304, Medical device software - software lifecycle processes. Request for questions on CE-conformity matters | 2012-05-25 | |||||
62A/812/RVNISO/TR 17791: Health informatics - Guidance on standards for enabling safety in health software | 2012-05-25 | no | ||||
62A/813/DCWorking Draft: ISO/TR 17791 Ed. 1.0: Health informatics - Guidance on standards for enabling safety in health software
| 2012-05-25 | 2012-07-27 | Report of Comments | |||
62A/814/CDVAmendment 1 - IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirements for basic safety and essentialperformance - Collateral Standard: General requirement for basic safety and essential performance - Collateral standard: Usability | 2012-05-25 | 2012-10-26 | yes | Voting Result | TC 66 TC 76 | |
62A/815/QProposal to repurpose IEC/TR 62348 to provide an Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005
| 2012-05-25 | 2012-07-27 | Report of Comments | |||
62A/816/NPApplication of risk management for IT-networks incorporating medical devices - Part 2-x: Guidance on distributed alarm systems | 2012-05-25 | 2012-09-07 | ? | Voting Result | ||
62A/810/INFResults of 62A/799/DC: Proposal to initiate a fast-track amendment to IEC 62366:2007, Medical devices - Application of usability engineering
| 2012-05-18 | |||||
62A/808/CCCompilation of comments on 62A/798/CD - IEC 62353: Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment | 2012-05-11 | yes | ||||
62A/809/CDISO/TR 24971: Guidance on the application of ISO 14971 | 2012-05-11 | 2012-08-17 | no | Report of Comments | TC 66 TC 76 | |
62A/806/CCCompilation of comments on 62A/794/CD - Amendment 1 to IEC 60601-1-6: Medical electrical equipment - Part 1-6: General requirement for basic safety and essential performance -Collateral standard: Usability | 2012-05-04 | yes | ||||
62A/807/RVCResult of voting on 62A/783/DTR - IEC/TR 80001-2-2: Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls | 2012-05-04 | no | ||||
62A/805/FDISAmendment 1 - IEC 60601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
| 2012-04-27 | 2012-06-29 | yes | Voting Result | TC 66 TC 76 | |
62A/803/RVCResult of voting on 62A/782/DTR - IEC/TR 80001-2-1 Ed1:Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks; Practical applications and examples | 2012-04-13 | no | ||||
62A/804/RVCResult of voting on 62A/804/DTR - IEC/TR 80001-2-3 Ed1: Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks | 2012-04-13 | no |
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