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BSI - BS EN 60601-1

Medical Electrical Equipment - Part 1: General Requirements for Safety and Essential Performance

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Organization: BSI
Publication Date: 30 November 2006
Status: inactive
Page Count: 384
ICS Code (Medical equipment in general): 11.040.01
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 See also 4.2.

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 3).

2) IEC 61010 (all parts), Safety requirements for electrical equipment for measurement, control, and laboratory use

3) ISO 14708-1, Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

Document History

May 31, 2019
Draft BS IEC 60601-1/AMD2 Amendment 2 - Medical electrical equipment Part 1: General requirements for basic safety and essential performance
A description is not available for this item.
November 30, 2006
Medical electrical equipment Part 1: General requirements for basic safety and essential performance
A description is not available for this item.
November 30, 2006
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
A description is not available for this item.
BS EN 60601-1
November 30, 2006
Medical Electrical Equipment - Part 1: General Requirements for 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....
November 30, 2006
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
A description is not available for this item.
November 30, 2006
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
A description is not available for this item.
November 30, 2006
Medical electrical equipment Part 1: General requirements for basic safety and essential performance
A description is not available for this item.
September 29, 1989
Medical Electrical Equipment Part 1: General Requirements for Safety
Covers constructional requirements, accompanying documentation, transport, storage, installation and maintenance of medical electrical equipment used to diagnose and treat the patient.
September 29, 1989
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...

References

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