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)

ISO 21647:2004 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. It supplements the requirements of IEC 60601-1:1988.
ISO 21647:2004 specifies requirements for anaesthetic gas monitoring, carbon dioxide monitoring and oxygen monitoring.
ISO 21647:2004 is not applicable to monitors intended for use with flammable anaesthetic agents.
The requirements of ISO 21647:2004 which replace or modify the requirements of IEC 60601-1:1988 and its Amendments 1 (1991) and 2 (1995) are intended to take precedence over the corresponding general requirements.
Environmental aspects are addressed in Annex CC. Additional aspects of environmental impact are addressed in ISO 14971.

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: 14-Apr-2009
• Withdrawal Date: 14-Dec-2011
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 15-Dec-2011
• Completion Date: 15-Dec-2011
• 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: 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)

Relations

• Replaces: EN ISO 21647:2004 - Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004)
• Effective Date: 08-Jun-2022
• Replaces: EN ISO 21647:2004/AC:2006 - Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004)
• Effective Date: 22-Apr-2009
• Replaced By: EN ISO 80601-2-55:2011 - 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-Feb-2012

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
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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
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,
...