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CEN

EN ISO 21647:2004

(Main)

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

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

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

Diese Norm legt besondere Anforderungen für die grundlegende Sicherheit und grundlegende Leistungsmerkmale von ÜBERWACHUNGSGERÄTEN FÜR ATEMGASE (respiratory gas monitor, RGM) (wie in 3.17 definiert) fest, die für die ununterbrochene Anwendung am Menschen bestimmt sind.
Gegenwärtig legt diese Norm 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 Norm.

Appareils électromédicaux - Prescriptions particulières relatives à la sécurité et aux performances de base des moniteurs de gaz respiratoires (ISO 21647:2004)

Elektromedicinska oprema – Posebne zahteve za osnovno varnost in bistvene lastnosti monitorjev dihalnih plinov (ISO 21647:2004)

General Information

Status
Withdrawn
Publication Date
14-Nov-2004
Withdrawal Date
14-Apr-2009
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-Apr-2009
Completion Date
15-Apr-2009
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 21647:2005 - Medical electrical equipment - Particular requirements for the basic safety and essential performance of respiratory gas monitors (ISO 21647:2004)

Relations

Replaces
EN 12598:1999 - Oxygen monitors for patient breathing mixtures - Particular requirements
Effective Date
22-Dec-2008
Replaces
EN ISO 11196:1997 - Anaesthetic gas monitors (ISO 11196:1995 including Technical Corrigendum 1:1997)
Effective Date
22-Dec-2008
Replaces
EN 864:1996 - Medical electrical equipment - Capnometers for use with humans - Particular requirements
Effective Date
22-Dec-2008
Replaced By
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)
Effective Date
08-Jun-2022
Corrected By
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
08-Jun-2022

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 21647:2005
01-marec-2005
1DGRPHãþD
SIST EN 12598:2000
SIST EN 864:2000
SIST EN ISO 11196:2000
Elektromedicinska oprema – Posebne zahteve za osnovno varnost in bistvene
lastnosti monitorjev dihalnih plinov (ISO 21647:2004)
Medical electrical equipment - Particular requirements for the basic safety and essential
performance of respiratory gas monitors (ISO 21647:2004)
Medizinische elektrische Geräte - Besondere Festlegungen für die grundlegende
Sicherheit und grundlegenden Leistungsmerkmale von Überwachungsgeräten für
Atemgase (ISO 21647:2004)
Appareils électromédicaux - Prescriptions particulieres relatives a la sécurité et aux
performances de base des moniteurs de gaz respiratoires (ISO 21647:2004)
Ta slovenski standard je istoveten z: EN ISO 21647:2004
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 21647:2005 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 21647:2005

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SIST EN ISO 21647:2005



EUROPEAN STANDARD
EN ISO 21647

NORME EUROPÉENNE

EUROPÄISCHE NORM
November 2004
ICS 11.040.10 Supersedes EN 12598:1999, EN 865:1997,
EN ISO 11196:1997
English version
Medical electrical equipment - Particular requirements for the
basic safety and essential performance of respiratory gas
monitors (ISO 21647:2004)
Appareils électromédicaux - Prescriptions particulières Medizinische elektrische Geräte - Besondere Festlegungen
relatives à la sécurité et aux performances de base des für die grundlegende Sicherheit und grundlegenden
moniteurs de gaz respiratoires (ISO 21647:2004) Leistungsmerkmale von Überwachungsgeräten für
Atemgase (ISO 21647:2004)
This European Standard was approved by CEN on 8 August 2004.

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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.

CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.




EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21647:2004: E
worldwide for CEN national Members.

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SIST EN ISO 21647:2005

EN ISO 21647:2004 (E)





Foreword


This document (EN ISO 21647:2004) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with 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 May 2005, and conflicting national standards shall
be withdrawn at the latest by May 2005.

This document supersedes EN 12598:1999, EN 865:1997 and EN ISO 11196:1997.

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, Cyprus,
Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland,
Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.


Endorsement notice

The text of ISO 21647:2004 has been approved by CEN as EN ISO 21647:2004 without any
modifications.
2

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SIST EN ISO 21647:2005

EN ISO 21647:2004 (E)




ANNEX ZA
(informati
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

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