EN ISO 21647:2009

SLOVENSKI STANDARD
01-julij-2009
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SIST EN ISO 21647:2005
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Medical electrical equipment - Particular requirements for the basic safety and essential
performance of respiratory gas monitors (ISO 21647:2004, including Cor 1:2005)
Appareils électromédicaux - Prescriptions particulières relatives à la sécurité et aux
performances de base des moniteurs de gaz respiratoires (ISO 21647:2004, Cor 1:2005
inclus)
Ta slovenski standard je istoveten z: EN ISO 21647:2009
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 21647
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 21647:2004
English Version
Medical electrical equipment - Particular requirements for the
basic safety and essential performance of respiratory gas
monitors (ISO 21647:2004, including Cor 1:2005)
Appareils électromédicaux - Prescriptions particulières
relatives à la sécurité et aux performances de base des
moniteurs de gaz respiratoires (ISO 21647:2004, Cor
1:2005 inclus)
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 21647:2009: 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 21647:2004, including Cor 1:2005 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 EN ISO 21647:2009 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic
equipment” the 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 21647:2004.
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 21647:2004, including Cor 1:2005 has been approved by CEN as a EN ISO 21647:2009
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 Essential Requirements (ERs) of Qualifying remarks/Notes
this EN Directive 93/42/EEC
- 6a) This relevant Essential Requirement
is not addressed in this European
Standard
- 7.5 (1st paragraph, 2nd sentence and These relevant Essential
2nd and 3rd paragraphs) Requirements are not addressed in
this European Standard
- 12.1a) This relevant Essential Requirement
is not addressed in this European
Standard
6.1 d) 13.3a) This relevant Essential Requirement
is only partly addressed in this
European Standard
6.1 d) 13.2, 13.3 a)
6.1 aa) to 6.1 hh) 13.2
6.1 dd) 13.3 f) The relevant Essential Requirement
13.3 f) is partly addressed
6.1 ee) 13.3 k)
6.1 ff) 13.3 e)
6.8.2 aa) 13.4
6.8.2 cc) 1) 6.8.2 hh), 13.6 b)
6.8.2 cc) 2) 13.6 a), 13.6 b)
6.8.2 cc) 3) 13.6 a), 13.6 d), 13.6 i)
6.8.2.cc) 3 13.6.h) The relevant Essential Requirement
13.6 h) is partly addressed
Clause(s)/sub-clause(s) of Essential Requirements (ERs) of Qualifying remarks/Notes
this EN Directive 93/42/EEC
- 13.6 q) This relevant Essential Requirement
is not addressed in this European
Standard
6.8.2 cc) 3) iv) 13.6 a), 13.6 h) The relevant Essential Requirement
13.6 h) is partly addressed
6.8.2 dd) 13.6 a), 13.6 c)
6.8.2 ee) 13.6 c)
6.8.2 ff) to 6.8.2 hh) 13.6 a)
Table BB.1 also applies.
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 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 EN
6.2, 101.3 1.5.4 This relevant Essential
Requirement is not fully
addressed in this EN
- 1.6.1 This relevant Essential
Requirement is not completely
addressed in this EN; see also
reference to IEC 60601-1
- 1.6.2 This relevant Essential
Requirement is not addressed
in this EN
- 1.6.3 This relevant Essential
Requirement is not completely
addressed in this EN; see
reference to IEC 60601-1
- 3.6.2 This relevant Essential
Requirement is not completely
addressed in this EN; see
reference to IEC 60601-1
INTERNATIONAL ISO
STANDARD 21647
First edition
2004-11-15
Medical electrical equipment — Particular
requirements for the basic safety and
essential performance of respiratory gas
monitors
Appareils électromédicaux — Prescriptions particulières relatives à la
sécurité et aux performances de base des moniteurs de gaz
respiratoires
Reference number
ISO 21647:2004(E)
©
ISO 2004
ISO 21647:2004(E)
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ISO 21647:2004(E)
Contents Page
Foreword. vi
Introduction . vii
1* Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 General requirements and general requirements for tests . 4
4.101 Other test methods . 4
4.102 Acceptance criteria . 4
5 Classification. 5
6 Identification, marking and documents. 5
6.1 Marking on the outside of equipment or equipment parts . 5
6.3 Markings of controls and instruments. 5
6.8.2* Instructions for use. 6
6.101* Test for legibility . 8
7 Power input. 8
8 Basic safety categories . 8
9 Removable protective means . 8
10 Environmental conditions. 8
10.1 Transport and storage . 8
10.2.2 Power supply. 8
11 Not used. 9
12 Not used.
...