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ISO 11197

Medical supply units

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Organization: ISO
Publication Date: 15 February 2016
Status: active
Page Count: 34
ICS Code (Anaesthetic, respiratory and reanimation equipment): 11.040.10
scope:

IEC 60601-1:2005+A1:2012, 1.1 is replaced by:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS,hereafter also referred to as ME EQUIPMENT

This International Standard applies to MEDICAL SUPPLY UNITS manufactured within a factory or assembled on site, including cabinetry and other ENCLOSURES, which incorporate PATIENT care services.

NOTE 1 A party that assembles on site various components intended for PATIENT care services into an ENCLOSURE is considered the MANUFACTURER of the MEDICAL SUPPLY UNIT.

HAZARDS inherent in the intended function of ME EQUIPMENT or ME SYSTEMS within the scope of this International Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 60601‐ 1:2005+A1:2012 (see 201.1.4).

NOTE 2 See also IEC 60601‐1:2005+A1:2012, 4.2.

Document History

June 19, 2019
Medical supply units
This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS, hereafter also referred to as ME EQUIPMENT. This document applies to MEDICAL SUPPLY UNITS manufactured...
ISO 11197
February 15, 2016
Medical supply units
IEC 60601-1:2005+A1:2012, 1.1 is replaced by: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS,hereafter also referred to as ME EQUIPMENT...
December 15, 2004
Medical supply units
A description is not available for this item.
January 1, 1996
Medical Electrical Equipment - Particular Requirements for Safety of Medical Supply Units First Edition
A description is not available for this item.

References

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