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 Work programme

Project Reference	Stage	Document Reference	Init. Date	Current Stage	Next Stage	Mod	Fcst. Publ. Date
IEC 60601-1-10 am1 Ed. 1.0 Amendment 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	ADIS ADIS Approved for FDIS circulation	62A/852/RVC 86 kB 89 kB	2012-07	2013-01	2013-06	yes	2013-11
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 used in the emergency medical services environment	CCDV CCDV Draft circulated as Committee Draft with Vote	62A/850/CDV 1365 kB 885 kB	2011-03	2013-03	2013-09	no	2014-05
IEC 60601-1-2 Ed. 4.0 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic phenomena - Requirements and tests	ADIS ADIS Approved for FDIS circulation	62A/832/RVC 512 kB 1165 kB	2006-11	2012-08	2013-06	no	2013-11
IEC 60601-1-6 am1 Ed. 3.0 Amendment 1 - 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	ADIS ADIS Approved for FDIS circulation	62A/842/RVC 70 kB 151 kB	2012-01	2012-11	2013-07	yes	2013-12
IEC 60601-1-9 am1 Ed. 1.0 Amendment 1 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design	CDIS CDIS Draft circulated as FDIS	62A/874/FDIS 265 kB 271 kB	2012-07	2013-03	2013-05	no	2013-07
IEC 62304 Ed. 2.0 Medical device software - Software life cycle processes	CDM CDM Committee Draft to be discussed at Meeting	62A/854/CC 157 kB 879 kB	2010-07	2013-01	2013-05	no	2014-01
IEC 62353 Ed. 2.0 Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment	CCDV CCDV Draft circulated as Committee Draft with Vote	62A/863/CDV 1596 kB 1989 kB	2010-12	2013-05	2013-11	no	2014-06
IEC 62366 am1 Ed. 1.0 Amendment 1 - Medical devices - Application of usability engineering to medical devices	ADIS ADIS Approved for FDIS circulation	62A/853/RVC 106 kB 202 kB	2012-07	2013-01	2013-06	no	2013-11
IEC 62366-1 Ed. 1.0 Medical devices - Part 1: Application of usability engineering to medical devices	CDM CDM Committee Draft to be discussed at Meeting	62A/872/CC 801 kB 1625 kB	2011-02	2013-03	2013-05	no	2014-08
IEC 62366-2 Ed. 1.0 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices	AMW AMW Approved Maintenance Work	62A/742/RR 304 kB	2011-02	2011-02	2012-10	no	2014-08
IEC 82304-1 Ed. 1.0 Healthcare Software Systems - Part 1: General requirements	CDM CDM Committee Draft to be discussed at Meeting	62A/855/CC 248 kB 452 kB	2011-03	2013-01	2013-06	no	2014-06
IEC/TR 80001-2-5 Ed. 1.0 Application of risk management for IT-networks incorporating medical devices - Part 2-5: Guidance on distributed alarm systems	ANW ANW Approved New Work	62A/847/RVN 1170 kB	2012-12	2012-12	2013-06	no	2014-12
ISO/TR 17791 Ed. 1.0 Health informatics - Guidance on Standards for Enabling Safety in Health Software	CDTR CDTR Circulated Draft Technical Report	62A/859/DTR 703 kB	2012-05	2013-02	2013-07	no	2013-12
ISO/TR 24971 Ed. 1.0 Guidance on the application of ISO 14971	APUB APUB Draft approved for publication	62A/857/RVC 250 kB 685 kB	2011-04	2013-01	2013-05	no	2013-10
ISO/TR 80001-2-6 Ed. 1.0 Application of risk management for IT-networks incorporating medical devices - Part 2-6: Guidance for responsibility agreements	ANW ANW Approved New Work	62A/873/RVN 689 kB	2013-03	2013-03	2013-09	no	2015-03
ISO/TR 80001-2-7 Ed. 1.0 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	ANW ANW Approved New Work	62A/879/RVN 622 kB	2013-05	2013-05	2013-09	no	2015-05
ISO/TR 80002-2 Ed. 1.0 Medical device software - Part 2: Validation of software for regulated processes	ANW ANW Approved New Work	62A/770/RVN 79 kB	2011-08	2011-08	2012-10	no
PNW 62A-880 Ed. 1.0 Medical electrical equipment - Part 4-x: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy	PNW PNW Proposed New Work	62A/880/NP 417 kB		2013-05	2013-09	no
PWI 62A-1 Ed. 1.0 IEC/ISO 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	PWI PWI Potential new work item			2013-05		no