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CEN

EN ISO 11197:2016

(Main)

Medical supply units (ISO 11197:2016)

Medical supply units (ISO 11197:2016)

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.

Medizinische Versorgungseinheiten (ISO 11197:2016)

Gaines techniques à usage médical (ISO 11197:2016)

Le paragraphe 1.1 de l'IEC 60601‑1:2005+A1:2012 est remplacé par:
ISO 11197:2016 s'applique à la sécurité de base et aux performances essentielles des gaines techniques à usage médical, également désignées sous le terme d'appareils em (appareils électromédicaux).
ISO 11197:2016 s'applique aux gaines techniques à usage médical fabriquées en usine ou montées sur site, y compris les armoires et autres enveloppes, qui intègrent des services de soins aux patients.
NOTE 1 Une entité qui monte sur site divers composants destinés à des services de soins aux patients pour constituer une enveloppe est considérée comme le fabricant de la gaine technique à usage médical.
Les dangers inhérents à la fonction prévue de l'appareil em ou des systèmes em dans le cadre du domaine d'application de la présente Norme internationale ne sont pas couverts par des exigences spécifiques contenues dans la présente norme, à l'exception des paragraphes 7.2.13 et 8.4.1 de l'IEC 60601‑1:2005+A1:2012 (voir 201.1.4).
NOTE 2 Voir également le paragraphe 4.2 de l'IEC 60601‑1:2005+A1:2012.

Enote za oskrbo v medicini (ISO 11197:2016)

Standard EN-ISO 11197 se uporablja za OSNOVNO VARNOST in BISTVENE LASTNOSTI ENOT ZA OSKRBO V MEDICINI (v nadaljevanju tudi: ELEKTROMEDICINSKA OPREMA). Ta mednarodni standard se uporablja za ENOTE ZA OSKRBO V MEDICINI, proizvedene v tovarni ali sestavljene na mestu uporabe, vključno z omaricami in drugimi OHIŠJI, ki zajemajo storitve oskrbe PACIENTOV.

General Information

Status
Withdrawn
Publication Date
08-Mar-2016
Withdrawal Date
26-Nov-2019
ICS
11.040.01 - Medical equipment in general
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215/WG 3 - Medical gas supply systems
Current Stage
9960 - Withdrawal effective - Withdrawal
Completion Date
27-Nov-2019
Directive
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
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
Mandate
M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
Ref Project
SIST EN ISO 11197:2016 - Medical supply units (ISO 11197:2016)

Relations

Replaces
EN ISO 11197:2009 - Medical supply units (ISO 11197:2004)
Effective Date
22-Dec-2008
Replaced By
EN ISO 11197:2019 - Medical supply units (ISO 11197:2019)
Effective Date
30-Aug-2017

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SLOVENSKI STANDARD
SIST EN ISO 11197:2016
01-maj-2016
1DGRPHãþD
SIST EN ISO 11197:2009
Enote za oskrbo v medicini (ISO 11197:2016)
Medical supply units (ISO 11197:2016)
Medizinische Versorgungseinheiten (ISO 11197:2016)
Gaines techniques à usage médical (ISO 11197:2016)
Ta slovenski standard je istoveten z: EN ISO 11197:2016
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 11197:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11197:2016

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SIST EN ISO 11197:2016


EN ISO 11197
EUROPEAN STANDARD

NORME EUROPÉENNE

March 2016
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 11197:2009
English Version

Medical supply units (ISO 11197:2016)
Gaines techniques à usage médical (ISO 11197:2016) Medizinische Versorgungseinheiten (ISO 11197:2016)
This European Standard was approved by CEN on 25 December 2015.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11197:2016 E
worldwide for CEN national Members.

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SIST EN ISO 11197:2016
EN ISO 11197:2016 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC . 4
2

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SIST EN ISO 11197:2016
EN ISO 11197:2016 (E)
European foreword
This document (EN ISO 11197:2016) has been prepared by Technical Committee
CEN/TC 215 “Respiratory and anaesthetic equipment”, the secretariat of which is held by BSI, in
collaboration with Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment”.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by September 2016, and conflicting national standards
shall be withdrawn at the latest by March 2019.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 11197:2009.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11197:2016 has been approved by CEN as EN ISO 11197:2016 without any modification.

3

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SIST EN ISO 11197:2016
EN ISO 11197:2016 (E)
Annex ZA
(informative)

Relationship
...

Questions, Comments and Discussion

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