IEC 60601-1:2005
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Standard No.

IEC 60601-1:2005

Release Date

2005

Published By

International Electrotechnical Commission (IEC)

Status

Be replaced

Replace By

IEC 60601-1:2005/COR1:2006

Latest

IEC 60601-1:2024 SER

Replace

IEC 62A/505A/FDIS:2005 IEC 60601-1:1988 IEC 60601-1 AMD 1:1991 IEC 60601-1 AMD 2:1995 IEC 60601-1 AMD 2 Corrigendum 1:1995

Scope

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELETRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS,hereafter referred to as ME EQUIPMENT and ME SYSTEMS. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only,or to ME SYSTEMS only, the title and content of that clause or subclause will say so.If that is not the case, the clause or subclause applies both to ME EQUIPMENT and to ME SYSTEMS,as relevant. HAZARDS inherent in teh intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirement in this standard except in 7.2.13 and 8.4.1. This standard can also be applied to equipment used for compensation or alleviation of desease,injury or disabiliby. In vitro diagnostic equipment that does not fall within the defintion fo ME EQUIPMENT is covered by the IEC 61010 series 2).This standard does not apply to the implantable parts of active implantable medical divices covered by ISO 14708-1 3).

IEC 60601-1:2005 Referenced Document

• IEC 60065:2001 Audio, video and similar electronic apparatus - Safety requirements
• IEC 60068-2-2:1974 Basic environmental testing procedures. Part 2 : Tests. Test B: Dry heat
• IEC 60079-0 Interpretation Sheet 2 - Explosive atmospheres - Part 0: Equipment - General requirements*， 2019-06-27 Update
• IEC 60079-2 Explosive atmospheres - Part 0: Equipment - General requirements*， 2024-04-18 Update
• IEC 60079-5 Amendment 1 - Explosive atmospheres - Part 5: Equipment protection by powder filling "q"*， 2022-05-12 Update

IEC 60601-1:2005 history

• 0000 IEC 60601-1:2024 SER
• 0000 IEC 60601-1:2023 SER
• 2022 IEC 60601-1:2005/COR3:2022 Corrigendum 3 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• 2015 IEC 60601-1:2022 Medical electrical equipment - ALL PARTS
• 2021 IEC 60601-1:2005/AMD1:2012/ISH1:2021 Interpretation Sheet 1 - Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• 2020 IEC 60601-1:2005/AMD2:2020 Amendment 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• 2020 IEC 60601-1:2020 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
• 2014 IEC 60601-1:2005/AMD1:2012/COR1:2014 Corrigendum 1 - Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• 2013 IEC 60601-1:2005/ISH3:2013 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Interpretation sheet 3
• 2012 IEC 60601-1:2005/AMD1:2012/COR1:2012 Corrigendum 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• 2012 IEC 60601-1:2012 Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
• 2009 IEC 60601-1:2005/ISH2:2009 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Interpretation sheet 2
• 2008 IEC 60601-1:2005/ISH1:2008 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• 2007 IEC 60601-1:2005/COR2:2007 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; Corrigendum 2
• 2006 IEC 60601-1:2005/COR1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; Corrigendum 1
• 2005 IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
• 1995 IEC 60601-1:1988/AMD2:1995/COR1:1995 Corrigendum 1 to Amendment 2 — Medical electrical equipment — Part 1: General requirements for safety
• 1995 IEC 60601-1/AMD2/COR1:1995 Medical electrical equipment - Part 1: General requirements for safety; Amendment 2
• 1970 IEC 60601-1:1988/AMD1:1991 Amendment 1 - Medical electrical equipment - Part 1: General requirements for safety
• 1988 IEC 60601-1:1988 Medical electrical equipment; part 1: general requirements for safety
• 1970 IEC 60601-1:1977/AMD1:1984 Amendment 1 - Medical electrical equipment. Part 1: General requirements.
• 1970 IEC 60601-1:1977 Medical electrical equipment. Part 1: General requirements.