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DS/EN 60601-1

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

active, Most Current
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Organization: DS
Publication Date: 15 October 2013
Status: active
Page Count: 142
ICS Code (Medical equipment in general): 11.040.01
scope:

1.1 * Scope Delete the fourth paragraph. Replace the fifth paragraph with: The IEC 60601 series does not apply to: - In vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT, which is covered by the IEC 61010 series 2); - implantable parts of active implantable medical devices covered by ISO 14708series 3); or - medical gas pipeline systems covered by ISO 7396-1 4).5 NOTE 2 ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and alarm signals.

Document History

October 11, 2021
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELEECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME...
November 14, 2014
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
A description is not available for this item.
May 23, 2014
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELEECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME...
DS/EN 60601-1
October 15, 2013
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
1.1 * Scope Delete the fourth paragraph. Replace the fifth paragraph with: The IEC 60601 series does not apply to: - In vitro diagnostic equipment that does not fall within the definition of ME...
May 17, 2013
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELEECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME...
November 25, 2011
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELEECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME...
May 8, 2008
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELEECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME...
February 1, 2008
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELEECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME...
December 12, 2006
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELEECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME...
Medical electrical equipment - Part 1: General requirements for safety
This is the major revised and updated baseline of standards for the safety of all medical electrical equipment used by or under the supervision of qualified personnel in the general medical and...
Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELEECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME...
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
1.1 * Scope Delete the fourth paragraph. Replace the fifth paragraph with: The IEC 60601 series does not apply to: - In vitro diagnostic equipment that does not fall within the definition of ME...
Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
1.1 * Scope Delete the fourth paragraph. Replace the fifth paragraph with: The IEC 60601 series does not apply to: - In vitro diagnostic equipment that does not fall within the definition of ME...
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