EN ISO 11197:2016

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC . 4
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.

Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association to provide a means of conforming to Essential
Requirements of Directive 93/42/EEC.
Once this standard is cited in the Official Journal of the European Union under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the normative
clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standard, a
presumption of conformity with the relevant Essential Requirements of that Directive.
NOTE When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Essential Qualifying remarks/Notes
Requirements
Clause(s)/subclause(s) of this EN
(ERs) of Directive
93/42/EEC
201.4 7.1 (first and
second indents)
201.5
201.6
201.8
201.9
201.11.7
201.12
201.13
201.15
201.13 7.3 (up to
semicolon)
201.15.4.101
201.15.4.102
201.15.4.103
201.11
201.7.2.1 9.1 (first sentence)
201.8
201.9.1
201.16
201.15
201.5.9.2.3 9.2 (first and Adds specific requirements
second indents)
201.6 Mandates 60601-2
201.8
201.9
201.10
201.17
201.8 9.3
201.11
201.11.2
201.12
201.13
201.15
201.16
201.15.101
201.10 11
201.14 12.1
201.14 12.1 a)
201.17 12.5
201.6.2 12.6
201.8
201.13
201.16
201.9 12.7.1
201.15
201.9.6 12.7.2
201.9.8
201.9.6 12.7.3
201.7 12.7.4 Only covered for gas connectors
201.7.2.8
201.15.4.101
201.4 12.7.5
201.11.1
201.7 12.9
201.7 13.1
201.7.2 13.3 a)
201.7.9.2 13.6 a) Covers item in 13.3 a) only
201.7.9.2 13.6 d)
201.7.9.2.16 13.6 i)
201.7.9.2.1 13.6 q)
NOTE Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with the Medical Devices Directive 93/42/EEC. This means that
RISKS have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’,
according to the wording of the corresponding essential requirement.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.

INTERNATIONAL ISO
STANDARD 11197
Third edition
2016-02-15
Medical supply units
Gaines techniques à usage médical
Reference number
ISO 11197:2016(E)
©
ISO 2016
ISO 11197:2016(E)
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
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ii © ISO 2016 – All rights reserved

ISO 11197:2016(E)
Contents
Foreword . v
Introduction . viii
201.1 Scope,object and related standards . 1
201.1.1 Scope . 1
201.1.2 Object . 1
201.1.3 Related standards. 1
201.1.3.1 Collateral standards . 1
201.1.3.2 Particular standards . 2
201.2 Normative references . 2
201.3 Terms and definitions . 4
201.4 General requirements . 5
201.5 General requirements for testing ME EQUIPMENT . 5
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 5
201.7 ME EQUIPMENT identification, marking and documents . 5
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 9
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15
201.10 Protection against unwanted and excessive radiation HAZARDS . 17
201.11 Protection against excessive temperatures and other HAZARDS . 17
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 17
201.13 HAZARDOUS SITUATIONS and fault conditions . 17
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18
201.15 Construction of ME EQUIPMENT . 18
201.16 ME SYSTEMS . 23
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 23
202 MEDICAL ELECTRICAL EQUIPMENT - part 1-2 General requirements for BASIC SAFETY and ESSENTIAL
PERFORMANCE – Collateral standard: Electromagnetic disturbances – Requirements and tests . 23
206 MEDICAL ELECTRICAL EQUIPMENT - part 1-6 General requirements for BASIC SAFETY and ESSENTIAL
PERFORMANCE – Collateral standard: Usability . 23
Annex AA (informative) Rationale . 24
Bibliography . 25
iv © ISO 2016 – All rights reserved

ISO 11197:2016(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non‐governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International
Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described in
the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO
documents should be Noted. This document was drafted in accordance with the editorial rules of the ISO/IEC
Directives, Part 2. www.iso.org/directives
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for iden
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