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 Project files
 Project Reference |  Current Stage | Language | Frcst Date | CLC | Document Reference | Downloads |
|---|---|---|---|---|---|---|
PNW 62A-130-8 Ed. 1.020 graphical symbols for general use | DEL
| E | 62A(NL)53 | |||
PNW 62A-130-9 Ed. 1.022 graphical symbols f0r use on medical equipment | DEL
| E | 62A(NL)54 | |||
PNW 62A-130-10 Ed. 1.014 graphical symbols indicating movement for use on medical equipment | DEL
| E | 62A(NL)55 | |||
PNW 62A-218 Ed. 1.0Medical devices - Risk management - Application of risk
management to medical devices
| DEL
| E | 62A/218 | |||
PNW 62A-287 Ed. 1.0Medical electrical equipment - x. Collateral Standard: Safety requirements for networked medical systems | DEL
| E | 62A/287 | |||
PNW 62A-580 Ed. 1.0Medical devices and medical systems - Basic safety and essential
performance of the patient-centric integrated clinicaenvironment (ICE) Part 1: General requirements for network controls
| DEL
| E | 62A/580 | |||
PNW 62A-672 Ed. 1.0Medical electrical equipment - Electromagnetic compatibility and safety with regard to electromagnetic disturbances - Requirements and tests | DEL
| E | 62A/672 | |||
PNW/TR 62A-843 Ed. 1.0ISO/TR 80001-2-x: Application of risk management for IT-networks incorporating medical devices - Part 2-x Guidance for responsibility agreements | PNW
| E | 62A/843 | |||
PNW/TR 62A-856 Ed. 1.0ISO/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 | PNW
| E | 62A/856 | |||
IEC 60417 f46 Ed. 1.0Amendment to IEC 417 and revision (or new edition) of IEC 60878
| DEL
| E | ||||
IEC 60417 f47 Ed. 1.0Amendment to IEC 60417 and revision (or new edition) of IEC 60878
| DEL
| E | ||||
IEC 60417 f48 Ed. 1.0Amendment to IEC 60417 and revision (or new edition) of IEC 60878
| DEL
| E | ||||
IEC/TR 60513 Ed. 2.0Fundamental aspects of safety standards for medical electrical equipment | PPUB
| B | Webstore | |||
IEC/TR 60513 Ed. 3.0Standardization of medical electrical equipment safety | DEL
| E | 2011-01 | no | ||
IEC 60601-1 Ed. 1.0Medical electrical equipment. Part 1: General requirements | DELPUB
| B | ||||
IEC 60601-1 Ed. 2.0Medical electrical equipment - Part 1: General requirements for safety | DELPUB
| B | ||||
IEC 60601-1 Ed. 3.0Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | PPUB
| B | yes | Webstore | ||
IEC 60601-1 f1 Ed. 3.0Third edition of IEC 601-1 - Additional Clauses to Clauses 2,
37, 41.5 and 43
| MERGED
| E | 62A(DE)77 | |||
IEC 60601-1 f11 Ed. 3.0Medical electrical equipment - Part 1: General requirements for safety and essential performance | MERGED
| E | yes | |||
IEC 60601-1 f2 Ed. 3.0Exception to the requirement regarding failure of components -
Sub-clause 52.5.9 -Failure of components- of IEC 601-1
| DEL
| E | 62A(SE)48 | |||
IEC 60601-1 f3 Ed. 3.0Amendment to IEC 601-1 to clarify Clause 19 regarding leakage
currents
| MERGED
| E | 62A(IT)28 | |||
IEC 60601-1 fC1 Ed. 3.0Corrigendum 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | PPUB
| B | Webstore | |||
IEC 60601-1 fC2 Ed. 3.0Corrigendum 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | PPUB
| B | Webstore | |||
IEC 60601-1 fI1 Ed. 3.0Interpretation sheet 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | PPUB
| B | 2008-05 | Webstore | ||
IEC 60601-1 fI2 Ed. 3.0Interpretation sheet 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | PPUB
| B | 2009-02 | Webstore | ||
IEC 60601-1 fI3 Ed. 3.0Interpretation Sheet 3 - Interpretation sheet for 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 | CDIS
| B | 62A/858 | |||
IEC 60601-1 am1 Ed. 2.0Amendment No. 1 | DELPUB
| B | 62A(C.O.)36 | |||
IEC 60601-1 am1 Ed. 3.0Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | PPUB
| B | 2012-08 | yes | Webstore | |
IEC 60601-1 am2 Ed. 2.0Amendment No. 2 | DELPUB
| B | yes | |||
IEC 60601-1-1 Ed. 1.0Medical electrical equipment - Part 1: General requirements for safety - Section 1: Collateral standard: Safety requirements for medical electrical systems | DELPUB
| B | 62A(C.O.)38 | |||
IEC 60601-1-1 Ed. 2.0Medical electrical equipment - Part 1-1: General requirements for
safety - Collateral standard: Safety requirements for medical
electrical systems
| PPUB
| B | 1999-10 | yes | Webstore | |
IEC 60601-1-1 am1 Ed. 1.0Amendment No. 1 | DELPUB
| B | yes | |||
IEC 60601-1-2 Ed. 1.0Medical electrical equipment - Part 1: General requirements for safety - 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests | DELPUB
| B | ||||
IEC 60601-1-2 Ed. 2.0Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility -
Requirements and tests
| DELPUB
| B | yes | |||
IEC 60601-1-2 Ed. 2.1Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests | DELPUB
| B | ||||
IEC 60601-1-2 Ed. 3.0Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | PPUB
| B | 2007-04 | yes | Webstore | |
IEC 60601-1-2 Ed. 4.0Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic phenomena - Requirements and tests | ADIS
| B | 2013-11 | yes | ||
IEC 60601-1-2 fF Ed. 2.1Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests | MERGED
| B | ||||
IEC 60601-1-2 fI1 Ed. 3.0Interpretation sheet 1 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
| PPUB
| B | 2010-03 | Webstore | ||
IEC 60601-1-2 ff Ed. 2.0Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
| MERGED
| B | ||||
IEC 60601-1-2 am1 Ed. 2.0Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests | DELPUB
| B | yes | |||
IEC 60601-1-2 am1 ff Ed. 2.0Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
| MERGED
| B | ||||
IEC 60601-1-6 Ed. 1.0Medical electrical equipment - Part 1-6: General requirements for safety - Collateral standard: Usability | DELPUB
| B | yes | |||
IEC 60601-1-6 Ed. 2.0Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | DELPUB
| B | 2006-12 | yes | ||
IEC 60601-1-6 Ed. 3.0Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | PPUB
| B | 2010-02 | yes | Webstore | |
IEC 60601-1-6 am1 Ed. 3.0Amendment 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
| B | 2013-12 | yes | ||
IEC 60601-1-8 Ed. 1.0Medical electrical equipment - Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems | DELPUB
| B | yes | |||
IEC 60601-1-8 Ed. 2.0Medical 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 | PPUB
| B | 2007-03 | yes | Webstore | |
IEC 60601-1-8 ff Ed. 1.0Medical electrical equipment - Part 1-8: General requirements for
safety - Collateral Standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment and medical electrical systems | MERGED
| B | ||||
IEC 60601-1-8 am1 Ed. 1.0Amendment 1 - Medical electrical equipment - Part 1-8: General requirements for safety - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems | DELPUB
| B | 2006-03 | yes | ||
IEC 60601-1-8 am1 Ed. 2.0Amendment 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
| PPUB
| B | 2012-11 | yes | Webstore | |
IEC 60601-1-9 Ed. 1.0Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design | PPUB
| B | 2007-08 | yes | Webstore | |
IEC 60601-1-9 am1 Ed. 1.0Amendment 1 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design | ADIS
| B | 2013-09 | yes | ||
IEC 60601-1-10 Ed. 1.0Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers | PPUB
| B | 2007-12 | yes | Webstore | |
IEC 60601-1-10 am1 Ed. 1.0Amendment 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
| B | 2013-11 | yes | ||
IEC 60601-1-11 Ed. 1.0Medical 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 | PPUB
| B | 2010-05 | yes | Webstore | |
IEC 60601-1-11 fC1 Ed. 1.0Corrigendum 1 - 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 | PPUB
| B | Webstore | |||
IEC 60601-1-12 Ed. 1.0Medical 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 | ACDV
| B | 2013-05 | yes | ||
IEC 60788 Ed. 1.0Medical radiology - Terminology | DELPUB
| B | ||||
DEL 60878 f6 Ed. 2.0Elements on graphical symbols in medical radiology
| DEL
| E | 62A(Sec.)119 | |||
DEL 60878 f9 Ed. 2.0Specific symbols for NMR - Specific symbols for ultrasonic diagnostic equipment - Specific symbols for cardiac pacemaker and for monitoring equipment | DEL
| B | ||||
IEC/TR 60878 Ed. 1.0Graphical symbols for electrical equipment in medical practice
| DELPUB
| B | ||||
IEC/TR 60878 Ed. 2.0Graphical symbols for electrical equipment in medical practice | PPUB
| B | no | Webstore | ||
DEL 60878 am1 f1 Ed. 2.08 graphical symbols for data processing on medical equipment
| DEL
| E | 62A/213 | |||
DEL 60878 am1 f2 Ed. 2.012 graphical symbols for radiologic equipment
| DEL
| E | 62A/214 | |||
DEL 60878 am1 f3 Ed. 2.014 graphical symbols for medical monitoring equipment
| DEL
| E | 62A/215 | |||
IEC 60878 am1 f1 Ed. 1.0Graphical symbols for use on medical equipment - Part 2: Nuclear
medicine
| MERGED
| B | yes | |||
IEC 60878 am1 f2 Ed. 1.0Graphical symbols for use on medical equipment - Part 3:
Radiological equipment
| MERGED
| B | yes | |||
IEC 60878 am1 f3 Ed. 1.0Graphical symbols for use on medical equipment - Part 1: General
| MERGED
| B | yes | |||
IEC/TR 60878 am1 f2 Ed. 1.0VOTING FORM to Graphical symbol: Multi-pulse (60417-IEC-5842 Pr) | MERGED
| E | 62A/299 | |||
IEC/TR 60878 am1 f3 Ed. 1.0VOTING FORM to Graphical symbol: Target position (60417-IEC-5843 Pr) | MERGED
| E | 62A/300 | |||
IEC/TR 60878 am1 f4 Ed. 1.0VOTING FORM to Graphical symbol: Body temperature (60417-IEC-5844 Pr) | MERGED
| E | 62A/301 | |||
IEC/TR 60878 am1 f5 Ed. 1.0VOTING FORM to Graphical symbol: Inner diameter (60417-IEC-5845 Pr) | MERGED
| E | 62A/302 | |||
IEC/TR 60878 am1 f6 Ed. 1.0VOTING FORM to Graphical symbol: Outer diameter (60417-IEC-5846 Pr) | MERGED
| E | 62A/303 | |||
IEC/TR 60878 am1 f7 Ed. 1.0VOTING FORM to Graphical symbol: Trend (60417-IEC-5847 Pr) | MERGED
| E | 62A/304 | |||
IEC/TR 60930 Ed. 1.0Guidelines for administrative, medical, and nursing staff concerned with the safe use of medical electrical equipment | DELPUB
| B | ||||
IEC/TR 60930 Ed. 2.0Guidelines for administrative, medical and nursing staff concerned with the safe use of medical electrical equipment and medical electrical systems | PPUB
| E | 2008-09 | no | Webstore | |
IEC/TR 60930 f1 Ed. 2.0Systematic review of IEC 930 (1988) | DEL
| B | ||||
IEC/TR 61258 Ed. 1.0Guidelines for the development and use of medical electrical equipment educational materials | DELPUB
| B | 62A(Sec.)102 | |||
IEC/TR 61258 Ed. 2.0Guidelines for the development and use of medical electrical equipment educational materials | PPUB
| E | 2008-09 | no | Webstore | |
IEC 61961 Ed. 1.0Safe technology management of electrical equipment for medical
use within health care
| DEL
| E | 62A/198 | |||
IEC/TR 62296 Ed. 1.0Considerations of unaddressed safety aspects in the Second Edition of IEC 60601-1 and proposals for new requirements | DELPUB
| E | 2003-10 | no | ||
IEC/TR 62296 Ed. 2.0Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements
| PPUB
| E | 2009-01 | no | Webstore | |
IEC 62304 Ed. 1.0Medical device software - Software life cycle processes | PPUB
| B | 2006-06 | yes | Webstore | |
IEC 62304 Ed. 2.0Medical device software - Software life cycle processes | CDM
| E | 2014-01 | yes | ||
IEC/TR 62348 Ed. 1.0Mapping between the clauses of the third edition of IEC 60601-1 and the 1988 edition as amended | DELPUB
| B | 2006-07 | no | ||
IEC/TR 62348 Ed. 2.0Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition | PPUB
| E | 2013-01 | no | Webstore | |
IEC 62353 Ed. 1.0Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment | PPUB
| B | 2007-05 | yes | Webstore | |
IEC 62353 Ed. 2.0Medical electrical equipment Recurrent test and test after repair of medical electrical equipment | CDM
| E | 2013-12 | yes | ||
IEC/TR 62354 Ed. 1.0General testing procedures for medical electrical equipment
| DELPUB
| B | 2006-02 | no | ||
IEC/TR 62354 Ed. 2.0General testing procedures for medical electrical equipment | PPUB
| E | 2009-10 | no | Webstore | |
IEC 62366 Ed. 1.0Medical devices - Application of usability engineering to medical devices | PPUB
| B | 2007-10 | yes | Webstore | |
IEC 62366 am1 Ed. 1.0Amendment 1 - Medical devices - Application of usability engineering to medical devices | ADIS
| B | 2013-11 | yes | ||
IEC 62366-1 Ed. 1.0Medical devices - Part 1: Application of usability engineering to medical devices | 1CD
| E | 2014-08 | yes | ||
IEC 62366-2 Ed. 1.0Medical devices - Part 2: Guidance on the application of usability engineering to medical devices | AMW
| E | 2014-08 | 62A/742 | ||
IEC 80001-1 Ed. 1.0Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities | PPUB
| B | 2010-10 | yes | Webstore | |
IEC/TR 80001-2-1 Ed. 1.0Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Pratical applications and examples | PPUB
| E | 2012-07 | no | Webstore | |
IEC/TR 80001-2-2 Ed. 1.0Application 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 | PPUB
| E | 2012-07 | no | Webstore | |
IEC/TR 80001-2-3 Ed. 1.0Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks | PPUB
| E | 2012-07 | no | Webstore | |
IEC/TR 80001-2-4 Ed. 1.0Application of risk management for IT-networks incorporating medical devices - Part 2-4: Application guidance - General implementation guidance for healthcare delivery organizations | PPUB
| E | 2012-12 | Webstore | ||
IEC/TR 80001-2-5 Ed. 1.0Application of risk management for IT-networks incorporating medical devices - Part 2-x: Guidance on distributed alarm systems | ANW
| E | 2014-12 | 62A/816 | ||
IEC/TR 80002-1 Ed. 1.0Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software | PPUB
| E | 2009-10 | no | Webstore | |
IEC 82304-1 Ed. 1.0Healthcare Software Systems - Part 1: General requirements | CDM
| E | 2014-06 | |||
ISO 14971 Ed. 1.0ISO/DIS 14971: Medical devices - Risk management - Application of risk management to medical devices
| PPUB
| B | yes | |||
ISO 14971 Ed. 2.0Medical devices - Application of risk management to medical devices | PPUB
| B | 2007-04 | no | ||
ISO 14971 am1 Ed. 1.0ISO 14971 Am. 1 Ed. 1: Medical devices - Application of risk management to medical devices | PPUB
| E | no | |||
ISO/TR 17791 Ed. 1.0Health informatics - Guidance on Standards for Enabling Safety in Health Software | CDTR
| E | 2013-12 | |||
ISO/TR 24971 Ed. 1.0Guidance on the application of ISO 14971 | APUB
| E | 2013-10 | no | ||
ISO/TR 80002-2 Ed. 1.0Medical device software - Part 2: Validation of software for regulated processes
| ANW
| E | 62A/754A |
32 kB
33 kB