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CEN - EN ISO 11197

Medical supply units

active, Most Current
Organization: CEN
Publication Date: 1 November 2019
Status: active
Page Count: 46
ICS Code (Anaesthetic, respiratory and reanimation equipment): 11.040.10
scope:

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 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 document are not covered by specific requirements in this standard, except in of IEC 60601-1:2005+A1:2012, 7.2.13 and 8.4.1 (see 201.1.4).

NOTE 2 Refer to IEC 60601-1:2005+A1:2012, 4.2.

Document History

EN ISO 11197
November 1, 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...
March 1, 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. ...
April 1, 2009
Medical supply units
A description is not available for this item.
December 1, 2004
Medical supply units
A description is not available for this item.

References

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