EN ISO 8835-5:2009

Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)

ISO 8835-5:2004 specifies particular requirements for the essential performance of anaesthetic ventilators (as defined in 3.1). ISO 8835-5:2004 is applicable to anaesthetic ventilators which are always a component of an anaesthetic system and are intended to be continuously attended by an operator.
ISO 8835-5:2004 is not applicable to anaesthetic ventilators intended for use with flammable anaesthetics, as determined by Annex BB.
The requirements of ISO 8835-5:2004 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.
This Scope is additional to the Scope given in IEC 60601-1:1988, Clause 1, except as noted above.

Systeme für die Inhalationsanästhesie - Teil 5: Anästhesie-Beatmungsgeräte (ISO 8835-5:2004)

Es gilt IEC 60601-1:1988, Abschnitt 1 mit folgenden Ausnahmen:
Dieser Teil von ISO 8835-5 legt besondere Anforderungen für die wesentliche Leistung von Anästhesie-
Beatmungsgeräten (wie in 3.1 definiert) fest. In diesem Teil von ISO 8835 behandelte Anästhesie-
Beatmungsgeräte sind immer ein Bestandteil eines Anästhesiesystems und dazu vorgesehen, ununterbrochen
durch einen Anwender überwacht zu werden.
Dieser Teil von ISO 8835 gilt nicht für Anästhesie-Beatmungsgeräte, die für die Verwendung mit brennbaren
Anästhesiemitteln bestimmt sind, wie in Anhang BB festgelegt.
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 5: Ventilateurs d'anesthésie (ISO 8835-5:2004)

L'ISO 8835-5:2004 spécifie des exigences particulières qui s'appliquent aux performances essentielles des ventilateurs d'anesthésie (définis en 3.1). L'ISO 8835-5:2004 couvre les ventilateurs d'anesthésie qui font toujours partie d'un système d'anesthésie et sont conçus pour être sous la surveillance continue d'un opérateur.
L'ISO 8835-5:2004 ne couvre pas les ventilateurs d'anesthésie qui sont conçus pour être utilisés avec des anesthésiques inflammables, déterminés selon l'Annexe BB.
Les exigences de l'ISO 8835-5:2004 qui remplacent ou modifient les exigences de la CEI 60601-1:1998, ainsi que ses Amendements 1 (1991) et 2 (1995), sont prévues pour être prioritaires par rapport aux exigences générales correspondantes.
Ce domaine d'application est additionnel au domaine d'application indiqué dans la CEI 60601-1:1988, Article 1, excepté ce qui précède.

Inhalacijski anestezijski sistemi - 5. del: Anestezijski ventilatorji (ISO 8835-5:2004)

General Information

• Status: Withdrawn
• Publication Date: 17-Mar-2009
• Withdrawal Date: 11-Dec-2012
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: CEN/TC 215 - Respiratory and anaesthetic equipment
• Drafting Committee: CEN/TC 215/WG 1 - Anaesthetic machines, medical breathing systems and anaesthetic gas scavenging systems
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 12-Dec-2012
• Completion Date: 12-Dec-2012
• 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 8835-5:2009 - Inhalational anaesthesia systems - Part 5: Anaesthesia ventilators (ISO 8835-5:2004)

Relations

• Replaces: EN ISO 8835-5:2004/AC:2006 - Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)
• Effective Date: 23-Mar-2009
• Replaces: EN ISO 8835-5:2004 - Inhalational anaesthesia systems - Part 5: Anaesthesia ventilators (ISO 8835-5:2004)
• Effective Date: 23-Mar-2009
• Replaces: EN ISO 8835-5:2004/AC:2004 - Inhalational anaesthesia systems - Part 5: Anaesthesia ventilators (ISO 8835-5:2004)
• Effective Date: 23-Mar-2009
• Replaced By: EN ISO 80601-2-13:2012 - Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation (ISO 80601-2-13:2011)
• Effective Date: 26-Dec-2012

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2009
1DGRPHãþD
SIST EN ISO 8835-5:2004
SIST EN ISO 8835-5:2004/AC:2005
SIST EN ISO 8835-5:2004/AC:2006
Inhalacijski anestezijski sistemi - 5. del: Anestezijski ventilatorji (ISO 8835-5:2004)
Inhalational anaesthesia systems - Part 5: Anaesthesia ventilators (ISO 8835-5:2004)
Systeme für die Inhalationsanästhesie - Teil 5: Anästhesie-Beatmungsgeräte (ISO 8835-
5:2004)
Systèmes d'anesthésie par inhalation - Partie 5: Ventilateurs d'anesthésie (ISO 8835-
5:2004)
Ta slovenski standard je istoveten z: EN ISO 8835-5:2009
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 8835-5
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2009
ICS 11.040.10 Supersedes EN ISO 8835-5:2004
English Version
Inhalational anaesthesia systems - Part 5: Anaesthetic
ventilators (ISO 8835-5:2004)
Systèmes d'anesthésie par inhalation - Partie 5: Systeme für die Inhalationsanästhesie - Teil 5: Anästhesie-
Ventilateurs d'anesthésie (ISO 8835-5:2004) Beatmungsgeräte (ISO 8835-5:2004)
This European Standard was approved by CEN on 1 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 8835-5:2009: 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 8835-5:2004 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 September 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 8835-5:2004.
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 8835-5:2004 has been approved by CEN as a EN ISO 8835-5:2009 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 - Relationship between this European Standard and the Essential Requirements of EU
Directive 93/42/EEC
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 & Not applicable
this Standard
2 IEC 60601-1: 1988 & Not applicable
this Standard
3 IEC 60601-1: 1988 , Not applicable
IEC 60601-2-
13:1998/ISO 8835-1,
ISO 4135 & this
Standard
- 6a) This relevant Essential
Requirement is not
addressed in this European
Standard
- 7.5 (1st paragraph, 2nd These relevant Essential
sentence and 2nd and 3rd Requirements are not
paragraphs) 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
4 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable
4.101 This Standard only 1 (first paragraph) to 6 (except
6 a)) as applicable
Clause(s)/sub- Where located Essential Requirements Qualifying remarks/Notes
clause(s) of this EN (ERs) of Directive 93/42/EEC
5 IEC 60601-1: 1988 1 to 6 as applicable
6 IEC 60601-1: 1988 1 (first paragraph) to 6 (except The relevant Essential
and IEC 60601-2- 6 a)) as applicable , 13.1, to requirement 13.3 a) is partly
13:1998/ISO 8835-1, 13.5 as applicable addressed
6.1 aa) This Standard only 1 (first paragraph) to 6 (except The relevant Essential
6 a)) as applicable , 13.1, to requirement 13.3 a) is partly
13.5 as applicable addressed
6.101 This Standard only 1 (first paragraph) to 6 (except
6 a)) as applicable
6.3 IEC 60601-1: 1988 1 (first paragraph) to 6 (except The relevant Essential
and IEC 60601-2- 6 a)) as applicable, 10.2, 10.3, requirement 13.3 a) is partly
13:1998/ISO 8835-1, 12.9, 13.1, to 13.5 as applicable addressed
6.3 aa) This Standard only 1 (first paragraph) to 6 (except
6 a)) as applicable, 10.2, 10.3,
and 12.9,
This Standard only 1 (first paragraph) to 6 (except
6.3 bb)
6 a)) as applicable, 10.2, 10.3,
and 12.9,
This Standard only 1 (first paragraph) to 6 (except
6.3 cc)
6 a)) as applicable, 10.2, 10.3,
and 12.9,
This Standard only 1 (first paragraph) to 6 (except
6.3 dd)
6 a)) as applicable, 10.2, 10.3,
and 12.9,
This Standard only 1 (first paragraph) to 6 (except
6.3 ee)
6 a)) as applicable, 10.2, 10.3,
and 12.9,
IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6.8.2 The relevant Essential
and IEC 60601-2- 6 a)) as applicable, 13.1, to
requirement 13.3 a) is partly
13:1998/ISO 8835-1, 13.5 as applicable, applicable
addressed
parts of 13.6 (except 13.6 q)
6.8.2 aa) This Standard only 1 (first paragraph) to 6 (except The relevant Essential
6 a)) as applicable, 13.1, to requirement 13.3 a) is partly
13.5 as applicable, applicable addressed
parts of 13.6 (except 13.6 q)
6.8.2 bb) This Standard only 1 (first paragraph) to 6 (except The relevant Essential
6 a)) as applicable, 13.1, to requirement 13.3 a) is partly
13.5 as applicable, applicable addressed
parts of 13.6 (except 13.6 q)
7 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable
8 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable
9 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable
10 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable
Clause(s)/sub- Where located Essential Requirements Qualifying remarks/Notes
clause(s) of this EN (ERs) of Directive 93/42/EEC
11 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable
12 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable
13 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable, 9.2. 2nd
dash, 12.6
14 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable, 9.2. 2nd
dash, 12.6
15 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable, 9.2. 2nd
dash, 12.6
16 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable, 9.2. 2nd
dash, 12.6
17 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable, 9.2. 2nd
dash, 12.6
18 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable, 9.2. 2nd
dash, 12.6
19 IEC 60601-1: 1988
1 (first paragraph) to 6 (except
6 a)) as applicable, 9.2. 2nd
dash, 12.6
20 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable, 9.2. 2nd
dash, 12.6
21 IEC 60601-1: 1988
1 (first paragraph) to 6 (except
6 a)) as applicable, 9.2. 1st
dash, 12.7.1
22 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable, 9.2. 1st
dash, 12.7.1
23 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable, 9.2. 1st
dash, 12.7.1
24 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) 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 (except
6 a)) as applicable, 9.2. 1st
dash, 12.7.1
Clause(s)/sub- Where located Essential Requirements Qualifying remarks/Notes
clause(s) of this EN (ERs) of Directive 93/42/EEC
29 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable, 9.2 2nd
dash, 11 as applicable
30 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable, 9.2 2nd
dash, 11 as applicable
31 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable, 9.2 2nd
dash, 11 as applicable
32 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable, 9.2 2nd
dash, 11 as applicable
33 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable, 9.2 2nd
dash, 11 as applicable
34 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable, 9.2 2nd
dash, 11 as applicable
35 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable, 9.2 2nd
dash, 11 as applicable
36 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
and this Standard 6 a)) as applicable, 9.2 2nd and
rd
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 (except
6 a)) as applicable, 7.1 (except,
rd
3 dash), 9.3, 12.7.5
43 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable, 7.1 (except,
rd
3 dash), 9.3, 12.7.5
43.101 This Standard only 1 (first paragraph) to 6 (except
6 a)) as applicable, 7.1 (except,
rd
3 dash), 9.3, 12.7.5
1 (first paragraph) to 6 (except
44 IEC 60601-1: 1988
6 a)) as applicable , 7.2 , 7.5
(first sentence), 7.6, 8.1 to 8.7
as applicable
44.3 This Standard only 1 (first paragraph) to 6 (except
6 a)) as applicable, 12.6, 12.7.1
Clause(s)/sub- Where located Essential Requirements Qualifying remarks/Notes
clause(s) of this EN (ERs) of Directive 93/42/EEC
44.8 This Standard only 1 (first paragraph) to 6 (except
6 a)) as applicable, 8.1 to 8.7
as applicable
45 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable, 9.2, 12.7.1
46 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
and this standard 6 a)) as applicable
47 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable
48 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable
49 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable, 12.6
50 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable
51 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable,
51.101 This Standard only 1 (first paragraph) to 6 (except
6 a)) as applicable, 9.1, 12.4
51.102 This Standard only 1 (first paragraph) to 6 (except
6 a)) as applicable, 12.8.1
51.103 This Standard only 1 (first paragraph) to 6 (except
6 a)) as applicable, 12.8.1
51.104 This Standard only 1 (first paragraph) to 6 (except
6 a)) as applicable, 12.8.1
52 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable, 12.6
53 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable, 12.6
54 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable, 9.1 to 9.3
as applicable, 12.7.4
55 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable
56 IEC 60601-1: 1988 1 (first paragraph) to 6 (except
6 a)) as applicable,
...