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CENELEC - EN 60601-1

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

active, Most Current
Organization: CENELEC
Publication Date: 1 October 2006
Status: active
Page Count: 426
ICS Code (Medical equipment): 11.040
scope:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred t o 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

text deleted

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 6060-1-80 to certain monitoring and ALARM SIGNALS.

Document History

EN 60601-1
October 1, 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 ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred t o as ME EQUIPMENT and ME...
October 1, 2006
Medical electrical equipment Part 1: General requirements for basic safety and essential performance
A description is not available for this item.
October 1, 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 ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS....
October 1, 2006
Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance
A description is not available for this item.
October 1, 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 ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS....
August 1, 1990
Medical Electrical Equipment Part 1: General Requirements for Safety
This Standard applies to the safety of MEDICAL ELECTRICAL EQUIPMENT (as defined in Sub-clause 2.2.15). Although this Standard is primarily concerned with safety, it contains some requirements...
August 1, 1990
Medical Electrical Equipment Part 1: General Requirements for Safety
A description is not available for this item.

References

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