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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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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.
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.
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.
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 normative 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.
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC
Clause/Subclause of Corresponding Essential Principal Comments
this Standard
6.1 d) 13.2, 13.3 a)
6.1 aa) to 6.1 hh) 13.2
6.1 dd) 13.3 f)
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) iv) 13.6 a), 13.6 h)
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.
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. 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 21647:2004(E)
27 Pneumatic and hydraulic power .12
28 Suspended masses.12
29 X-Radiation.
...
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