This standard applies to the safety of medical electrical equipment (see definition in 2.2.15). Although this standard deals primarily with safety issues, it also includes some safety-related requirements for reliable operation. Safety hazards arising from the expected physiological effects of the equipment covered by this standard have not been considered. Unless explicitly stated in the text of the standard, the appendix content in the standard does not require mandatory implementation. The purpose of this standard is to stipulate the general safety requirements for medical electrical equipment and serve as the basis for the special safety requirements for medical electrical equipment.
IEC 60601-1:1988 history
0000 IEC 60601-1:2024 SER
0000 IEC 60601-1:2023 SER
2022IEC 60601-1:2005/COR3:2022 Corrigendum 3 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
2021IEC 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
2020IEC 60601-1:2005/AMD2:2020 Amendment 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
2020IEC 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
2014IEC 60601-1:2005/AMD1:2012/COR1:2014 Corrigendum 1 - Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
2013IEC 60601-1:2005/ISH3:2013 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Interpretation sheet 3
2012IEC 60601-1:2005/AMD1:2012/COR1:2012 Corrigendum 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
2012IEC 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
2009IEC 60601-1:2005/ISH2:2009 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Interpretation sheet 2
2008IEC 60601-1:2005/ISH1:2008 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
2007IEC 60601-1:2005/COR2:2007 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; Corrigendum 2
2006IEC 60601-1:2005/COR1:2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; Corrigendum 1
2005IEC 60601-1:2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance