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AAMI ES60601-1

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

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Organization: AAMI
Publication Date: 1 January 2005
Status: active
Page Count: 428
scope:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL 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 the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1.

NOTE 1 See also 4.2.

The IEC 60601 series does not apply to:

- in vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT is covered by the IEC 61010 series [61];

- implantable parts of active implantable medical devices covered by the ISO 14708 series [69]; or

- medical gas pipeline systems covered by ISO 7396-1 [68].

NOTE 2 ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and ALARM SIGNALS.

intended Use:

INTENDED PURPOSE

use for which a product, PROCESS or service is intended according to the specifications, instructions and information provided by the... View More

Document History

August 20, 2012
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, Amendments
A description is not available for this item.
AAMI ES60601-1
January 1, 2005
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 ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS....
January 1, 2005
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 ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS....
January 1, 2005
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 ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS....
January 1, 2005
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 ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS....
January 1, 2005
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 ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS....

References

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