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SRPS EN ISO 11197:2017

Medical supply units (ISO 11197:2016)

Sep 25, 2017

General information

60.60     Sep 25, 2017

ISS

Z076

European Norm

11.040.10  

English  

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Scope

IEC 60601-1:2005+A1:2012, 1.1 is replaced by:
ISO 11197:2016 applies to the basic safety and essential performance of medical supply units, hereafter also referred to as me equipment.
ISO 11197:2016 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.

Related directives

Directives related to this standard.

93/42/EEC

Medical devices

2007/47/EC

Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market

Life cycle

PREVIOUSLY

WITHDRAWN
SRPS EN ISO 11197:2011

NOW

PUBLISHED
SRPS EN ISO 11197:2017
60.60 Standard published
Sep 25, 2017

REVISED BY

PUBLISHED
SRPS EN ISO 11197:2020

Related project

Adopted from EN ISO 11197:2016

Adopted from ISO 11197:2016 IDENTICAL