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NEN-EN-ISO 11197

Medical supply units

active, Most Current
Organization: NEN
Publication Date: 1 December 2019
Status: active
Page Count: 52
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

NEN-EN-ISO 11197
December 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
NEN-EN-ISO 11197 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS, NT. hereafter also referred to as ME EQUIPME This International Standard applies to MEDICAL SUPPLY...
May 1, 2013
Medical supply units
NEN-EN-ISO 11197 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS, NT. hereafter also referred to as ME EQUIPME This International Standard applies to MEDICAL SUPPLY...
June 1, 2012
Medical supply units
NEN-EN-ISO 11197 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS, NT. hereafter also referred to as ME EQUIPME This International Standard applies to MEDICAL SUPPLY...
May 1, 2009
Medical supply units
Clause 1 of EN 60601-1:1990 applies with the following addition: This document applies to medical supply units as defined in 3.5. This particular document applies in conjunction with EN 60601-1. The...
January 1, 2005
Medical supply units
Clause 1 of EN 60601-1:1990 applies with the following addition: This document applies to medical supply units as defined in 3.5. This particular document applies in conjunction with EN 60601-1. The...
May 1, 2002
Medical supply units
Clause 1 of EN 60601-1:1990 applies with the following addition: This document applies to medical supply units as defined in 3.5. This particular document applies in conjunction with EN 60601-1. The...

References

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