EN ISO 11197:2009
(Main)Medical supply units (ISO 11197:2004)
Medical supply units (ISO 11197:2004)
ISO 11197:2004 specifies requirements and test methods for medical supply units intended for use in healthcare facilities to supply electric power and/ medical gases and/or liquids and anaesthetic gas scavenging systems. It is applicable in conjunction with IEC 60601-1:1988.
The requirements of ISO 11197:2004 take priority over those of IEC 60601-1:1988.
Medizinische Versorgungseinheiten (ISO 11197:2004)
Abschnitt 1 der EN 60601-1:1990 gilt mit folgenden Abweichungen:
Diese Norm gilt für MEDIZINISCHE VERSORGUNGSEINHEIT nach 3.5.
Diese Besonderen Festlegungen gelten zusammen mit denen der EN 60601-1.
Die Anforderungen dieser Besonderen Norm haben Vorrang vor denen der EN 60601-1.
Gaines techniques à usage médical (ISO 11197:2004)
Enote za oskrbo v medicini (ISO 11197:2004)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2009
1DGRPHãþD
SIST EN ISO 11197:2005
Enote za oskrbo v medicini (ISO 11197:2004)
Medical supply units (ISO 11197:2004)
Medizinische Versorgungseinheiten (ISO 11197:2004)
Gaines techniques à usage médical (ISO 11197:2004)
Ta slovenski standard je istoveten z: EN ISO 11197:2009
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.
EUROPEAN STANDARD
EN ISO 11197
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 11197:2004
English Version
Medical supply units (ISO 11197:2004)
Gaines techniques à usage médical (ISO 11197:2004) Medizinische Versorgungseinheiten (ISO 11197:2004)
This European Standard was approved by CEN on 21 March 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11197:2009: E
worldwide for CEN national Members.
Contents Page
Foreword .3
Annex ZA (Informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
Foreword
The text of ISO 11197:2004 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
secretariat of which is held by BSI.
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 October 2009, and conflicting national standards shall be withdrawn at
the latest by March 2010.
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 11197:2004.
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 EC Directive.
For relationship with EC Directive, 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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 11197:2004 has been approved by CEN as a EN ISO 11197:2009 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 the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the 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 corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 – Correspondence between this European Standard and EU Directives
Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying
EN Directive 93/42/EEC remarks/Notes
All 1 (1st paragraph), 1 (2nd paragraph 1st
dash), 1 (2nd paragraph 2nd dash)
All 2
All 3
4 6,9.3
6.1a) 13.3a)
6.1g) 13.3a), 13.3b)
6.1k) 13.2, 13.3a), 13.3b)
6.1l) 13.3b)
6.1y) 13.2, 13.3b)
6.1aa) 13.2, 13.3b)
6.2 7.6, 9.1
6.8 7.1, 13.1, 13.4, 13.6a), b), c), d)
6.8.2 13.1, 13.6a), b), c), d)
6.8.2a) 13.4
6.8.3 13.1
Section 3 12.6
Section 4 12.7.1
21.101 4, 9.2
21.101.2 9.2
21.101.3 9.2
26.101 12.7.2, 12.7.3
36.101 12.5
42 12.7.5
42.101 12.7.5
43 7.1, 9.3
43.2 7.1, 9.3
56.1 9.2, 12.6
57.1 9.2, 12.6
57.2 9.2, 12.6
57.6 9.2, 12.6
58.101 9.2, 12.6
59.101.1 12.7.4
59.101.1a) 7.1, 7.3
59.101.2 7.3, 12.7.4
59.101.2a) 7.3
59.101.2c) 7.5
59.102.2c) 7.5
59.103.1a) 7.1, 7.3
59.103.1b) 7.1, 7.3
59.103.1c) 7.1, 7.3
59.103.2b) 7.5
59.104.1 9.1, 12.7.4
59.104.2 9.1, 12.7.4
59.104.3a) 9.1
59.104.3e) 7.1, 7.3
59.104.3g) 9.1
- 13.6q) This relevant Essential
Requirement is not
addressed in this European
Standard : covered by EN
ISO 13485: 2003, subclause
4.2.3
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on Machinery,
in accordance with Article 3 of Directive 93/42/EEC the following table ZA.2 details the relevant essential
requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific than those
of Directive 93/42/EEC along with the corresponding clauses of this European Standard. Table ZA.2,
however, does not imply any citation in the OJEU under the machinery directive and thus does not provide
presumption of conformity for the machinery directive.
Table ZA.2 – Relevant Essential Health and Safety Requirements from Directive 2006/42/EC on
machinery that are addressed by this European Standard
(according to article 3 of amended Directive 93/42/EEC)
Clause(s)/sub-clause(s) of this Essential Health and Safety Qualifying remarks/Notes
EN Requirements (EHSRs) of
Directive 2006/42/EC
- 1.1.4 This relevant Essential Requirement is
not addressed in this European
Standard. To be addressed by
EN14971 and in some cases portions
of EN 60601-1;3rd ed.
- 1.2.2 This relevant EHSR is not specifically
addressed in this European standard;
only partially covered by EN 60601-1-
6 and EN 14971
- 1.5.4 This relevant EHSR is not specifically
addressed in this European standard;
only partially covered in EN 14971
and EN 62366
- 1.6.1 This relevant EHSR is only partly
addressed in subclause 6.8.2 of this
European standard; see EN 60601-1
and EN 14971
- 1.6.2 This relevant EHSR is not addressed
in this European standard; see EN
60601-1 and EN 14971
- 1.6.3 This relevant Essential Requirement is
not addressed in this European
Standard.
- 3.4.5 This relevant EHSR is not specifically
addressed in this European standard:
it is partially covered in EN 60601-1
and EN 14971
- 3.6.2 This relevant Essential Requirement is
not addressed in this European
Standard
INTERNATIONAL ISO
STANDARD 11197
Second edition
2004-12-15
Medical supply units
Gaines techniques à usage médical
Reference number
ISO 11197:2004(E)
©
ISO 2004
ISO 11197:2004(E)
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ISO 11197:2004(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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 identifying any or all such patent rights.
ISO 11197 was prepared by the European Committee for Standardization (CEN) in collaboration with
Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 6, Medical gas
systems, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).
Throughout the text of this document, read “.this European Standard.” to mean “.this International
Standard.”.
This second edition cancels and replaces the first edition (ISO 11197:1996), which has been technically
revised.
Annex ZB provides a list of corresponding International and European Standards for which equivalents are not
given in the text.
For the purposes of this International Standard, the CEN annex regarding fulfilment of European Council
Directives has been removed.
ISO 11197:2004(E)
Contents
page
Foreword.vii
Introduction .viii
SECTION ONE - GENERAL .1
1 Scope .1
2 Normative references .1
3 Terms and definitions .2
4 General requirements and requirements for tests.2
5 Classification.3
6 Identification, marking and documents.3
7 Power input .7
SECTION TWO - ENVIRONMENTAL CONDITIONS .8
...
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