EN ISO 8835-4:2009
(Main)Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)
Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)
For the purposes of ISO 8835-4:2004, the requirements in IEC 60601-1:1988, Clause 1 apply except as follows.
Addition:
ISO 8835-4:2004 specifies particular requirements for the essential performance of anaesthetic vapour delivery devices (AVDDs), as defined in 3.1. ISO 8835-4:2004 is applicable to AVDDs which are a component of an anaesthetic system and are intended to be continuously operator-attended. ISO 8835-4:2004 gives specific requirements for AVDDs which are supplementary to the applicable general requirements in IEC 60601-2-13.
ISO 8835-4:2004 is not applicable to AVDDs intended for use with flammable anaesthetics, as determined by Annex CC, and AVDDs intended for use within anaesthetic breathing systems (e.g. draw-over vaporizers).
The requirements of ISO 8835-4:2004 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.
Systeme für die Inhalationsanästhesie - Teil 4: Anästhesiemittelverdampfer (ISO 8835-4:2004)
Es gilt IEC 60601-1:1988, Abschnitt 1, mit folgenden Ausnahmen:
Ergänzung:
Dieser Teil von ISO 8835 legt besondere Anforderungen für die grundlegende Leistung von Anästhesie-mittelverdampfern (AVDD von engl. Anaesthetic Vapour Delivery Devices) (wie in 3.1 definiert) fest. Dieser Teil von ISO 8835 gilt für AVDDs, die ein Bestandteil eines Anästhesiesystems sind und ununterbrochen durch einen Anwender bedient werden. Dieser Teil von ISO 8835 enthält spezielle Anforderungen für AVDDs, die zusätzlich zu den anwendbaren allgemeinen Anforderungen in IEC 60601-2-13 gelten.
Dieser Teil von ISO 8835 gilt nicht für AVDDs, die für die Verwendung mit brennbaren Anästhesiemitteln bestimmt sind, wie in Anhang CC festgelegt, und nicht für AVDDs zur Verwendung in Anästhesie-atemsystemen (z. B. Überströmverdampfer).
Die Anforderungen von diesem Teil von ISO 8835, die die Anforderungen von IEC 60601-1:1988 und ihrer Änderungen 1 (1991) und 2 (1995) ersetzen oder verändern, haben Vorrang vor den entsprechenden allgemeinen Anforderungen.
Systèmes d'anesthésie par inhalation - Partie 4: Dispositifs d'administration de vapeur anesthésique (ISO 8835-4:2004)
Pour les besoins de l'ISO 8835-4:2004, la CEI 60601-1:1988, Article 1 s'applique, à l'exception de ce qui suit.
Ajout:
L'ISO 8835-4:2004 spécifie des exigences particulières qui s'appliquent aux performances essentielles des dispositifs d'administration de vapeur anesthésique (DAVA), comme définis en 3.1. La présente partie de l'ISO 8835 couvre les DAVA qui font partie d'un système d'anesthésie et sont conçus pour être sous la surveillance continue d'un opérateur. Les exigences particulières aux DAVA de la présente partie de l'ISO 8835 s'ajoutent aux exigences générales applicables de la CEI 60601-2-13.
L'ISO 8835-4:2004ne couvre pas les DAVA conçus pour être utilisés avec des anesthésiques inflammables, tels que déterminés selon l'Annexe CC, ni ceux conçus pour être utilisés dans des systèmes respiratoires d'anesthésie (par exemple les systèmes à alimentation en vapeur).
Les exigences de la présente partie de l'ISO 8835-4:2004 qui remplacent ou modifient les exigences de la CEI 60601-1:1988, ainsi que ses Amendements 1 (1991) et 2 (1995), sont prévues pour avoir la priorité sur les exigences générales correspondantes.
Sistemi za inhalacijsko anestezijo - 4. del: Naprave za dovajanje anestezijskih hlapov (hlapilniki) (ISO 8835-4:2004)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2009
1DGRPHãþD
SIST EN ISO 8835-4:2005
SIST EN ISO 8835-4:2005/AC:2005
SIST EN ISO 8835-4:2005/AC:2006
Sistemi za inhalacijsko anestezijo - 4. del: Naprave za dovajanje anestezijskih
hlapov (hlapilniki) (ISO 8835-4:2004)
Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO
8835-4:2004)
Systeme für die Inhalationsanästhesie - Teil 4: Anästhesiemittelverdampfer (ISO 8835-
4:2004)
Systèmes d'anesthésie par inhalation - Partie 4: Dispositifs d'administration de vapeur
anesthésique (ISO 8835-4:2004)
Ta slovenski standard je istoveten z: EN ISO 8835-4:2009
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 8835-4
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 8835-4:2004
English Version
Inhalational anaesthesia systems - Part 4: Anaesthetic vapour
delivery devices (ISO 8835-4:2004)
Systèmes d'anesthésie par inhalation - Partie 4: Dispositifs Systeme für die Inhalationsanästhesie - Teil 4:
d'administration de vapeur anesthésique (ISO 8835-4:2004) Anästhesiemittelverdampfer (ISO 8835-4:2004)
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 8835-4:2009: 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 8835-4:2004 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
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 8835-4:2004.
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 8835-4:2004 has been approved by CEN as a EN ISO 8835-4:2009 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- Where located Essential Requirements Qualifying remarks/Notes
clause(s) of this EN (ERs) of Directive
93/42/EEC
IEC 60601-1: 1988 & this Not applicable
Standard
2 IEC 60601-1: 1988 & this Not applicable
Standard
3 IEC 60601-1: 1988 , IEC Not applicable
60601-2-13:1998/ISO
8835-1, ISO 4135 & this
Standard
4 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable
4.101 This Standard only 1 (first paragraph) to 6 as
applicable
5 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable
6 IEC 60601-1: 1988 and IEC 1 (first paragraph) to 6 as The relevant Essential
60601-2-13:1998/ISO applicable , 13.1, to 13.5 as requirement 13.3 a) is partly
8835-1, applicable addressed
6.1 aa) This Standard only 1 (first paragraph) to 6 as The relevant Essential
applicable , 13.1, to 13.5 as requirement 13.3 a) is partly
applicable addressed
6.101 This Standard only 1 (first paragraph) to 6 as
applicable
6.3 IEC 60601-1: 1988 and IEC 1 (first paragraph) to 6 as The relevant Essential
60601-2-13:1998/ISO applicable, 10.2, 10.3, 12.9, requirement 13.3 a) is partly
8835-1, 13.1, to 13.5 as applicable addressed
6.3 aa) This Standard only 1 (first paragraph) to 6 as
applicable, 10.2, 10.3, and
12.9,
This Standard only 1 (first paragraph) to 6 as
6.3 bb)
applicable, 10.2, 10.3, and
12.9,
This Standard only 1 (first paragraph) to 6 as
6.3 cc)
applicable, 10.2, 10.3, and
12.9,
This Standard only 1 (first paragraph) to 6 as
6.3 dd)
applicable, 10.2, 10.3, and
12.9,
This Standard only 1 (first paragraph) to 6 as
6.3 ee)
applicable, 10.2, 10.3, and
12.9,
IEC 60601-1: 1988 and IEC 1 (first paragraph) to 6 as
6.8.2 The relevant Essential
60601-2-13:1998/ISO applicable, 13.1, to 13.5 as
requirement 13.3 a) is partly
8835-1, applicable, applicable parts
addressed
of 13.6
6.8.2 aa) This Standard only 1 (first paragraph) to 6 as The relevant Essential
applicable, 13.1, to 13.5 as requirement 13.3 a) is partly
applicable, applicable parts addressed
of 13.6
6.8.2 bb) This Standard only 1 (first paragraph) to 6 as The relevant Essential
applicable, 13.1, to 13.5 as requirement 13.3 a) is partly
applicable, applicable parts addressed
of 13.6
7 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable
8 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable
9 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable
10 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable
11 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable
12 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable
13 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.2. 2nd dash,
12.6
14 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.2. 2nd dash,
12.6
15 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.2. 2nd dash,
12.6
16 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.2. 2nd dash, 12.6
17 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.2. 2nd dash, 12.6
18 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.2. 2nd dash, 12.6
19 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.2. 2nd dash, 12.6
20 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.2. 2nd dash, 12.6
21 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.2. 1st dash, 12.7.1
22 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.2. 1st dash, 12.7.1
23 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.2. 1st dash, 12.7.1
24 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.2. 1st dash, 12.7.1
25 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.2. 1st dash, 12.7.1
28 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.2. 1st dash, 12.7.1
29 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.2 2nd dash, 11 as
applicable
30 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.2 2nd dash, 11 as
applicable
31 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.2 2nd dash, 11 as
applicable
32 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.2 2nd dash, 11 as
applicable
33 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.2 2nd dash, 11 as
applicable
34 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.2 2nd dash, 11 as
applicable
35 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.2 2nd dash, 11 as
applicable
36 IEC 60601-1: 1988 and this 1 (first paragraph) to 6 as
rd
Standard applicable, 9.2 2nd and 3 dash, 11
as applicable, 12.5
37 This Standard only
38 This Standard only
39 This Standard only
40 This Standard only
41 This Standard only
42 IEC 60601-1: 1988 1 (first paragraph) to 6 as
rd
applicable, 7.1 (except, 3 dash),
9.3, 12.7.5
43 IEC 60601-1: 1988 1 (first paragraph) to 6 as
rd
applicable, 7.1 (except, 3 dash),
9.3, 12.7.5
43.101 This Standard only 1 (first paragraph) to 6 as
rd
applicable, 7.1 (except, 3 dash),
9.3, 12.7.5
1 (first paragraph) to 6 as
44 IEC 60601-1: 1988
applicable , 7.2 , 7.5 (first
sentence), 7.6, 8.1 (first paragraph)
to 8.7 as applicable
44.3 This Standard only 1 (first paragraph) to 6 as
applicable, 12.6, 12.7.1
44.8 This Standard only 1 (first paragraph) to 6 as
applicable, 8.1 (first paragraph) to
8.7 as applicable
45 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.2, 12.7.1
46 IEC 60601-1: 1988 and this 1 to 6 as applicable
standard
47 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable
48 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable
49 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 12.6
50 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable
51 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable,
51.101 This Standard only 1 (first paragraph) to 6 as
applicable, 9.1, 12.4
51.102 This Standard only 1 (first paragraph) to 6 as
applicable, 12.8.1
51.103 This Standard only 1 (first paragraph) to 6 as
applicable, 12.8.1
51.104 This Standard only 1 (first paragraph) to 6 as
applicable, 12.8.1
52 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 12.6
53 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 12.6
54 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.1 (first paragraph) to
9.3 as applicable, 12.7.4
55 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable
56 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.1 (first paragraph) to
9.3 as applicable, 12.6, 12.7.4
57 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.1 (first paragraph) to
9.3 as applicable, 12.6, 12.7.4
58 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.1 (first paragraph) to
9.3 as applicable, 12.6, 12.7.4
59 IEC 60601-1: 1988 1 (first paragraph) to 6 as
applicable, 9.1 (first paragraph) to
9.3 as applicable, 12.6, 12.7.4
101.1 This Standard only 1 (first paragraph) to 6 as
applicable,
101.2 This Standard only 1 (first paragraph) to 6 as
applicable, 12.7.4
101.3 This Standard only 1 (first paragraph) to 6 as
applicable, 12.9
101.4 This Standard only 1 (first paragraph) to 6 as
applicable, 12.9
101.5 This Standard only 1 (first paragraph) to 6 as
applicable, 8.1
101.6 This Standard only 1 (first paragraph) to 6 as
applicable, 9.2
- 6a This relevant Essential
Requirement is not
addressed in this
European Standard
- 7.5 (1st paragraph, 2nd sentence These relevant
and 2nd and 3rd paragraphs) Essential Requirements
are not addressed in
this European Standard
12.1a) This relevant Essential
Requirement is not
addressed in this
European Standard
- 13.6 (q) This relevant Essential
Requirement is not
addressed in this
European Standard
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
...
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