SIST EN ISO 21647:2009

Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004, including Cor 1:2005)

This International Standard specifies particular requirements for the basic safety and essential performance of respiratory gas monitors (RGM) (as defined in 3.15) intended for continuous operation for use with humans. This International Standard specifies requirements for aa) anaesthetic gas monitoring, bb) carbon dioxide monitoring, cc) oxygen monitoring. This International Standard is not applicable to monitors intended for use with flammable anaesthetic agents.

Medizinische elektrische Geräte - Besondere Festlegungen für die grundlegende Sicherheit und grundlegenden Leistungsmerkmale von Überwachungsgeräten für Atemgase (ISO 21647:2004, einschließlich Cor 1:2005)

Abschnitt 1 von IEC 60601-1:1998 gilt mit folgender Abweichung:
Ergänzung (nach 1.1):
Diese Internationale Norm legt besondere Anforderungen für die grundlegende Sicherheit und grundlegende
Leistungsmerkmale von Überwachungsgeräten für Atemgase (respiratory gas monitor, RGM – wie in 3.15
definiert) fest, die für die ununterbrochene Anwendung am Menschen bestimmt sind.
Diese Internationale Norm legt Anforderungen fest für:
aa) Überwachungsgeräte für Anästhesiegase;
bb) Überwachungsgeräte für Kohlendioxid;
cc) Überwachungsgeräte für Sauerstoff.
Überwachungsgeräte, die für die Verwendung mit brennbaren Anästhesiemitteln bestimmt sind, liegen
außerhalb des Anwendungsbereichs dieser Internationalen Norm.
Anforderungen dieser Internationalen Norm, die Anforderungen der IEC 60601-1:1988 einschließlich ihrer
Änderungen 1 (1991) und 2 (1995), ersetzen oder ändern haben Vorrang vor den entsprechenden
Allgemeinen Festlegungen.
Umwelteinflüsse werden im Anhang CC beschrieben.
ANMERKUNG Weitere Aspekte von Umwelteinflüssen werden in ISO 14971[4] behandelt.

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)

L'ISO 21647:2004 spécifie les prescriptions particulières relatives à la sécurité et aux performances de base des moniteurs de gaz respiratoire (MGR) (tels que définis en 3.15) destinés à être utilisés en régime continu sur l'homme. Elle complète les exigences de la CEI 60601-1:1988
L'ISO 21647:2004 définit les prescriptions relatives au contrôle des gaz d'anesthésie, au contrôle du dioxyde de carbone et au contrôle de l'oxygène.
Les moniteurs destinés à être utilisés avec des agents anesthésiques inflammables ne font pas partie du domaine d'application de l'ISO 21647:2004.
Les exigences de l'ISO 21647:2004 qui remplacent ou modifient les exigences de la CEI 60601-1:1988 et ses Amendements 1 (1991) et 2 (1995) sont destinées à avoir la priorité sur les prescriptions générales correspondantes.
Les aspects environnementaux sont traités dans l'Annexe CC. D'autres aspects de l'impact environnemental sont traités dans l'ISO 14971.

Elektromedicinska oprema - Posebne zahteve za osnovno varnost in bistvene lastnosti monitorjev dihalnih plinov (ISO 21647:2004, vključno s popravkom A1:2005)

General Information

• Status: Withdrawn
• Publication Date: 31-May-2009
• Withdrawal Date: 03-Oct-2013
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 04-Oct-2013
• Due Date: 27-Oct-2013
• Completion Date: 04-Oct-2013
• 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
• Directive: 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: EN ISO 21647:2009 - Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004, including Cor 1:2005)

Relations

• Replaced By: SIST EN ISO 80601-2-55:2013 - Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2011)
• Effective Date: 01-Nov-2013
• Replaces: SIST EN ISO 21647:2005 - Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004)
• Effective Date: 01-Jul-2009
• Replaces: SIST EN ISO 21647:2005/AC:2006 - Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004)
• Effective Date: 01-Jul-2009
• Replaces: SIST EN ISO 21647:2005 - Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 21647:2009
01-julij-2009
1DGRPHãþD
SIST EN ISO 21647:2005
SIST EN ISO 21647:2005/AC:2006
(OHNWURPHGLFLQVNDRSUHPD3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQELVWYHQH
ODVWQRVWLPRQLWRUMHYGLKDOQLKSOLQRY,62YNOMXþQRVSRSUDYNRP
$
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
SIST EN ISO 21647:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 21647:2009

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SIST EN ISO 21647:2009
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.

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SIST EN ISO 21647:2009
EN ISO 21647:2009 (E)
Contents Page
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 21647:2009
EN ISO 21647:2009 (E)
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.
3

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SIST EN ISO 21647:2009
EN ISO 21647:2009 (E)
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
4

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SIST EN ISO 21647:2009
EN ISO 21647:2009 (E)

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.
5

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SIST EN ISO 21647:2009
EN ISO 21647:2009 (E)
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

6

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SIST EN ISO 21647:2009


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

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SIST EN ISO 21647:2009
ISO 21647:2004(E)
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©  ISO 2004
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
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ii © ISO 2004 – All rights reserved

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SIST EN ISO 21647:2009
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. 9
13 General. 9
14 Requirements related to classification . 9
15 Limitation of voltage and/or energy . 9
16 Enclosures and protective covers . 9
17 Separation. 9
18 Protective earthing, functional earthing and potential equalization . 9
19 Continuous leakage currents and patient auxiliary currents . 9
20 Dielectric strength. 9
21* Mechanical strength . 9
21.101 Shock and vibration. 10
21.102 Shock and vibration for transport . 10
22 Moving parts. 11
23 Surfaces, corners and edges. 11
24 Stability in normal use. 11
25 Expelled parts. 11
26 Vibration and noise. 12
© ISO 2004 – All rights reserved iii

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SIST EN ISO 21647:2009
ISO 21647:2004(E)
27 Pneumatic and hydraulic power .12
28 Suspended masses.12
29 X-Radiation.12
30 Alpha, beta, gamma, neutron radiation and other particle radiation.12
31 Microwave radiation.12
32 Light radiation (including lasers).12
33 Infra-red radiation.12
34 Ultraviolet radiation.12
35 Acoustical energy (including ultrasonics).12
36* Electromagnetic compatibility .12
37 Locations and basic requirements.13
38 Marking and accompanying documents.13
39 Common requirements for category AP and category APG equipment .13
40 Requirements and tests for category AP equipment, parts and components thereof .13
41 Requirements and tests for category APG equipment, parts and components thereof .13
42 Excessive temperatures .13
43* Fire prevention.13
43.101 RGM used in conjunction with oxidants.13
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility.14
44.3 Spillage.14
44.7 Cleaning, sterilization and disinfection .14
44.8 Compatibility with substances used with the equipment .14
45 Pressure vessels and parts subject to pressure .15
46 Human errors .15
47 Electrostatic charges .15
48 Biocompatibility.15
49 Interruption of the power supply .15
49.101 Power failure alarm conditions.15
49.102 Settings and data storage following short interruptions or automatic switchover .15
49.103 Reserve electrical power source .16
49.104 Reserve electrical power source for use outside the healthcare facility .16
50 Accuracy of operating data .16
51 Protection against hazardous output.16
51.101* Measurement accuracy.16
51.102 Total system response time .19
51.103 Indication of gas readings units of measure.20
51.104 Indication of operating mode.20
52 Abnormal operation and fault conditions.20
53 Environmental tests .20
54 General .20
55 Enclosures and covers .20
56 Components and general assembly.20
56.7 Batteries .20
iv © ISO 2004 – All rights reserved

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SIST EN ISO 21647:2009
ISO 21647:2004(E)
57 Mains parts, components and layout. 20
57.3 Power supply cords . 21
58 Protective earthing — terminals and connections . 21
59 Construction and layout. 21
101 Additional requirements specifically related to respiratory gas monitors . 21
101.1 Interfering gas and vapour effects . 21
101.2 Gas leakage . 22
101.3* Exhaust port connector for diverting respiratory gas monitor. 22
101.4 Minimum sampling flowrate. 22
101.5 Contamination of breathing systems. 23
102 Alarm systems. 23
201.1.2* Alarm condition priority. 23
201.2 Disclosures for intelligent alarm system. 25
201.5 Alarm presets . 25
201.5.1 General requirements . 25
201.6.2 Adjustable alarm limit. 25
201.8 Alarm signal inactivation states . 25
201.8.3 Indication and access. 25
103 Appendices of IEC 60601-1:1988. 25
Annex A A (informative) Rationale. 26
Annex B B (informative) Reference to the Essential Principles . 33
Annex C C (informative) Environmental aspects . 36
Annex D D (informative) Vocabulary — Index of defined terms . 38
Bibliography . 40

© ISO 2004 – All rights reserved v

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SIST EN ISO 21647:2009
ISO 21647:2004(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 21647 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 1, Breathing attachments and anaesthetic machines.
This first edition of ISO 21647 cancels and replaces ISO 7767:1997, ISO 9918:1993 and ISO 11196:1995,
which have been technically revised.
vi © ISO 2004 – All rights reserved

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SIST EN ISO 21647:2009
ISO 21647:2004(E)
Introduction
This International Standard is a Particular Standard based on IEC 60601-1:1988, including Amendments 1
(1991) and 2 (1995), hereafter referred to as the General Standard. The General Standard is the basic
standard for the safety of all medical electrical equipment used by or under the supervision of qualified
personnel in the general medical and patient environment; it also contains certain requirements for reliable
operation to ensure safety.
The General Standard has associated Collateral Standards and Particular Standards. The Collateral
Standards include requirements for specific technologies and/or hazards and apply to all applicable equipment,
such as medical systems, EMC, radiation protection in diagnostic X-ray equipment, software, etc. T
...