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NEN-EN-IEC 60601-1

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

active
Organization: NEN
Publication Date: 1 October 2006
Status: active
Page Count: 410
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 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. This standard can also be applied to equipment used for compensation or alleviation of disease, injury or disability. In vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT is covered by the IEC 61010 series 2). This standard does not apply to the implantable parts of active implantable medical devices covered by ISO 14708-1. This EN 60601-1:2006 has been significantly restructured compared to EN 60601-1:1990. Requirements in the electrical section have been further aligned with those for information technology equipment covered by EN 60950-1 and a requirement for including a RISK MANAGEMENT PROCESS has been added. For an expanded description of this revision, see Clause A.3.

Document History

October 1, 2014
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
A description is not available for this item.
August 1, 2014
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
A description is not available for this item.
October 1, 2013
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
A description is not available for this item.
November 1, 2011
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
A description is not available for this item.
March 1, 2010
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
DOW changed to 2012-06-01 and sentence has to be deleted.
December 1, 2007
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
A description is not available for this item.
January 1, 2007
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
A description is not available for this item.
NEN-EN-IEC 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 to as ME EQUIPMENT and ME SYSTEMS....

References

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