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Norm

ISO 11197:2019

Ausgabedatum: 2019 11 07

Medical supply units

IEC 60601-1:2005+A1:2012, 1.1 is replaced by: This document applies to the basic safety and essential performance of medical supply units, hereafter also referred to as ...
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Herausgeber:
International Organization for Standardization
Format:
Digital | 36 Seiten
Sprache:
Englisch

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

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.

ISO 11197:2019
2019 11 07
Medical supply units
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ISO 11197:2016
2016 02 11
Medical supply units
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ISO 11197:2004
2004 12 01
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ISO 11197:1996
1996 04 18
Medical electrical equipment — Particular requirements for safety of medical supply units
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