SIST EN ISO 8835-5:2004/AC:2006

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

TC - Modification to title, foreword and addition of Table ZA.1

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

Systemes d'anesthésie par inhalation - Partie 5: Ventilateurs d'anesthésie (ISO 8835-5:2004)

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

General Information

• Status: Withdrawn
• Publication Date: 31-Mar-2006
• Withdrawal Date: 10-May-2009
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 11-May-2009
• Due Date: 03-Jun-2009
• Completion Date: 11-May-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: EN ISO 8835-5:2004/AC:2006 - Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)

Relations

• Replaced By: SIST EN ISO 8835-5:2009 - Inhalational anaesthesia systems - Part 5: Anaesthesia ventilators (ISO 8835-5:2004)
• Effective Date: 01-Jun-2009
• Corrects: SIST EN ISO 8835-5:2004 - Inhalational anaesthesia systems - Part 5: Anaesthesia ventilators (ISO 8835-5:2004)
• Effective Date: 22-Dec-2008
• Replaces: SIST EN ISO 8835-5:2004/AC:2005 - Inhalational anaesthesia systems - Part 5: Anaesthesia ventilators (ISO 8835-5:2004)
• Effective Date: 22-Dec-2008
• Corrects: SIST EN ISO 8835-5:2004 - Inhalational anaesthesia systems - Part 5: Anaesthesia ventilators (ISO 8835-5:2004)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8835-5:2004/AC:2006
01-april-2006
1DGRPHãþD
SIST EN ISO 8835-5:2004/AC:2005
Inhalacijski anestezijski sistemi – 5. del: Anestezijski ventilatorji (ISO 8835-5:2004)
Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)
Systeme für die Inhalationsanästhesie - Teil 5: Anästhesie-Beatmungsgeräte (ISO 8835-
5:2004)
Systemes d'anesthésie par inhalation - Partie 5: Ventilateurs d'anesthésie (ISO 8835-
5:2004)
Ta slovenski standard je istoveten z: EN ISO 8835-5:2004/AC:2006
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 8835-5:2004/AC:2006 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8835-5:2004/AC:2006

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SIST EN ISO 8835-5:2004/AC:2006
EUROPEAN STANDARD
EN ISO 8835-5:2004/AC
NORME EUROPÉENNE
January 2006
Janvier 2006
EUROPÄISCHE NORM
Januar 2006
ICS 11.040.10
English version
Version Française
Deutsche Fassung
Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO
8835-5:2004)
Systèmes d'anesthésie par inhalation - Systeme für die Inhalationsanästhesie - Teil
Partie 5: Ventilateurs d'anesthésie (ISO 5: Anästhesie-Beatmungsgeräte (ISO
8835-5:2004) 8835-5:2004)
This corrigendum becomes effective on 25 January 2006 for incorporation in the three official
language versions of the EN.
Ce corrigendum prendra effet le 25 janvier 2006 pour incorporation dans les trois versions
linguistiques officielles de la EN.
Die Berichtigung tritt am 25.Januar 2006 zur Einarbeitung in die drei offiziellen Sprachfassungen der
EN in Kraft.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members.
Tous droits d'exploitation sous quelque forme et de quelque manière que ce soit réservés dans le monde entier aux
membres nationaux du CEN.
Alle Rechte der Verwertung, gleich in welcher Form und in welchem Verfahren, sind weltweit den nationalen Mitgliedern
von CEN vorbehalten.
Ref. No.:EN ISO 8835-5:2004/AC:2006 D/E/F

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SIST EN ISO 8835-5:2004/AC:2006
EN ISO 8835-5:2004/AC:2006 (E/F/D)
English version

Title page
Title
Modification to the title:
Inhalational anaesthesia systems - Part 5: ventilators (ISO 8835-5:2004)
Anaesthetic

The note is to be modified as follows: “Partially supersedes EN 740:1998”

Foreword
The third sentence is to be modified as follows: “This document partially supersedes EN
740:1998.”

Annex ZA
The following Table is to be added:
Table ZA.1 — Correspondence between this Standard and the Essential Requirements
Corresponding paragraph of EEC
Clauses Where located Comment
Directive 93/42/EEC
of this
Standard
1 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
4 IEC 60601-1: 1988 1 to 6 as applicable
4.101 This Standard only 1 to 6 as applicable
5 IEC 60601-1: 1988 1 to 6 as applicable
6 IEC 60601-1: 1988 1 to 6 as applicable , 13.1, to 13.5 as
and IEC 60601-2- applicable
13:1998/ISO 8835-
1,
6.1 aa) This Standard only 1 to 6 as applicable , 13.1, to 13.5 as
applicable
6.101 This Standard only 1 to 6 as applicable
6.3 IEC 60601-1: 1988 1 to 6 as applicable, 10.2, 10.3, 12.9,
and IEC 60601-2- 13.1, to 13.5 as applicable
13:1998/ISO 8835-
1,
6.3 aa) This Standard only 1 to 6 as applicable, 10.2, 10.3, and
12.9,
This Standard only 1 to 6 as applicable, 10.2, 10.3, and
6.3 bb)
12.9,
This Standard only 1 to 6 as applicable, 10.2, 10.3, and
6.3 cc)
12.9,
2

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SIST EN ISO 8835-5:2004/AC:2006
EN ISO 8835-5:2004/AC:2006 (E/F/D)
Corresponding paragraph of EEC
Clauses Where located Comment
Directive 93/42/EEC
of this
Standard
This Standard only 1 to 6 as applicable, 10.2, 10.3, and
6.3 dd)
12.9,
This Standard only 1 to 6 as applicable, 10.2, 10.3, and
6.3 ee)
12.9,
IEC 60601-1: 1988 1 to 6 as applicable, 13.1, to 13.5 as
6.8.2
and IEC 60601-2- applicable, applicable parts of 13.6
13:1998/ISO 8835-
1,
6.8.2 aa) This Standard only 1 to 6 as applicable, 13.1, to 13.5 as
applicable, applicable parts of 13.6
6.8.2 bb) This Standard only 1 to 6 as applicable, 13.1, to 13.5 as
applicable, applicable parts of 13.6
7 IEC 60601-1: 1988 1 to 6 as applicable
8 IEC 60601-1: 1988 1 to 6 as applicable
9 IEC 60601-1: 1988 1 to 6 as applicable
10 IEC 60601-1: 1988 1 to 6 as applicable
11 IEC 60601-1: 1988 1 to 6 as applicable
12 IEC 60601-1: 1988 1 to 6 as applicable
13 IEC 60601-1: 1988 1 to 6 as applicable, 9.2. 2nd dash,
12.6
14 IEC 60601-1: 1988 1 to 6 as applicable, 9.2. 2nd dash,
12.6
15 IEC 60601-1: 1988 1 to 6 as applicable, 9.2. 2nd dash,
12.6
16 IEC 60601-1: 1988 1 to 6 as applicable, 9.2. 2nd dash,
12.6
17 IEC 60601-1: 1988 1 to 6 as applicable, 9.2. 2nd dash,
12.6
18 IEC 60601-1: 1988 1 to 6 as applicable, 9.2. 2nd dash,
12.6
19 IEC 60601-1: 1988 1 to 6 as applicable, 9.2. 2nd dash,
12.6
20 IEC 60601-1: 1988 1 to 6 as applicable, 9.2. 2nd dash,
12.6
21 IEC 60601-1: 1988 1 to 6 as applicable, 9.2. 1st dash,
12.7.1
22 IEC 60601-1: 1988 1 to 6 as applicable, 9.2. 1st dash,
12.7.1
23 IEC 60601-1: 1988 1 to 6 as applicable, 9.2. 1st dash,
12.7.1
24 IEC 60601-1: 1988 1 to 6 as applicable, 9.2. 1st dash,
12.7.1
3

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SIST EN ISO 8835-5:2004/AC:2006
EN ISO 8835-5:2004/AC:2006 (E/F/D)
Corresponding paragraph of EEC
Clauses Where located Comment
Directive 93/42/EEC
of this
Standard
25 IEC 60601-1: 1988 1 to 6 as applicable, 9.2. 1st dash,
12.7.1
28 IEC 60601-1: 1988 1 to 6 as applicable, 9.2. 1st dash,
12.7.1
29 IEC 60601-1: 1988 1 to 6 as applicable, 9.2 2nd dash, 11
as applicable
30 IEC 60601-1: 1988 1 to 6 as applicable, 9.2 2nd dash, 11
as applicable
31 IEC 60601-1: 1988 1 to 6 as applicable, 9.2 2nd dash, 11
as applicable
32 IEC 60601-1: 1988 1 to 6 as applicable, 9.2 2nd dash, 11
as applicable
33 IEC 60601-1: 1988 1 to 6 as applicable, 9.2 2nd dash, 11
as applicable
34 IEC 60601-1: 1988 1 to 6 as applicable, 9.2 2nd dash, 11
as applicable
35 IEC 60601-1: 1988 1 to 6 as applicable, 9.2 2nd dash, 11
as applicable
rd
36 IEC 60601-1: 1988 1 to 6 as applicable, 9.2 2nd and 3
and this Standard 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 to 6 as applicable, 7.1, 9.3, 12.7.5
43 IEC 60601-1: 1988 1 to 6 as applicable, 7.1, 9.3, 12.7.5
43.101 This Standard only 1 to 6 as applicable, 7.1, 9.3, 12.7.5
1 to 6 as applicable , 7.2 , 7.5, 7.6, 8.1
44 IEC 60601-1: 1988
to 8.7 as applicable
44.3 This Standard only 1 to 6 as applicable, 12.6, 12.7.1
44.8 This Standard only 1 to 6 as applicable, 8.1 to 8.7 as
applicable
45 IEC 60601-1: 1988 1 to 6 as applicable, 9.2, 12.7.1
46 IEC 60601-1: 1988 1 to 6 as applicable
and this standard
47 IEC 60601-1: 1988 1 to 6 as applicable
48 IEC 60601-1: 1988 1 to 6 as applicable
49 IEC 60601-1: 1988 1 to 6 as applicable, 12.6
4

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SIST EN ISO 8835-5:2004/AC:2006
EN ISO 8835-5:2004/AC:2006 (E/F/D)
Corresponding paragraph of EEC
Clauses Where located Comment
Directive 93/42/EEC
of this
Standard
50 IEC 60601-1: 1988 1 to 6 as applicable
51 IEC 60601-1: 1988 1 to 6 as applicable,
51.101 This Standard only 1 to 6 as applicable, 9.1, 12.4
51.102 This Standard only 1 to 6 as applicable, 12.8.1
51.103 This Standard only 1 to 6 as applicable, 12.8.1
51.104 This Standard only 1 to 6 as applicable, 12.8.1
52 IEC 60601-1: 1988 1 to 6 as applicable, 12.6
53 IEC 60601-1: 1988 1 to 6 as applicable, 12.6
54 IEC 60601-1: 1988 1 to 6 as applicable, 9.1 to 9.3 as
applicable, 12.7.4
55 IEC 60601-1: 1988 1 to 6 as applicable
56 IEC 60601-1: 1988 1 to 6 as applicable, 9.1 to 9.3 as
applicable, 12.6, 12.7.4
57 IEC 60601-1: 1988 1 to 6 as applicable, 9.1 to 9.3 as
applicable, 12.6, 12.7.4
58 IEC 60601-1: 1988 1 to 6 as applicable, 9.1 to 9.3 as
applicable, 12.6, 12.7.4
59 IEC 60601-1: 1988 1 to 6 as applicable, 9.1 to 9.3 as
applicable, 12.6, 12.7.4
101.1 This Standard only 1 to 6 as applicable,
101.2 This Standard only 1 to 6 as applicable, 12.7.4
101.3 This Standard only 1 to 6 as applicable, 12.9
101.4 This Standard only 1 to 6 as applicable, 12.9
101.5 This Standard only 1 to 6 as applicable, 8.1
101.6 This Standard only 1 to 6 as applicable, 9.2

5

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SIST EN ISO 8835-5:2004/AC:2006
EN ISO 8835-5:2004/AC:2006 (E/F/D)
Version française
Page de titre
La note suivante doit être ajoutée : “Remplace partiellement l’EN 740:1998”
Avant-propos
La phrase suivante doit être ajoutée : “Ce document remplace partiellement
l’EN 740:1998.”
Annexe ZA
Le Tableau suivant doit être ajouté :
Tableau ZA.1 — Correspondance entre la présente norme et les exigences essentielles
Articles de Localisation Paragraphe correspondant de la Remarques
la présente Directive CEE 93/42
norme
1 CEI 60601-1:1988 & la présente Sans objet
norme
2 CEI 60601-1:1988 & la présente Sans objet
norme
3 CEI 60601-1:1988, CEI 60601-2- Sans objet
13:1998/ISO 8835-1, ISO 4135 &
la présente norme
4 CEI 60601-1:1988 1 à 6 s’il y a lieu
4.101 La présente norme uniquement 1 à 6 s’il y a lieu
5 CEI 60601-1:1988 1 à 6 s’il y a lieu
6 CEI 60601-1:1988 et 1 à 6 s’il y a lieu, 13.1, à 13.5 s’il y a
CEI 60601-2-13:1998/ISO 8835-1, lieu
6.1 aa) La présente norme uniquement 1 à 6 s’il y a lieu, 13.1, à 13.5 s’il y a
lieu
6.101 La présente norme uniquement 1 à 6 s’il y a lieu
6.3 CEI 60601-1:1988 et 1 à 6 s’il y a lieu, 10.2, 10.3, 12.9,
CEI 60601-2-13:1998/ISO 8835-1, 13.1, à 13.5 s’il y a lieu
6.3 aa) La présente norme uniquement 1 à 6 s’il y a lieu, 10.2, 10.3, et 12.9,
6.3 bb) La présente norme uniquement 1 à 6 s’il y a lieu, 10.2, 10.3, et 12.9,
6.3 cc) La présente norme uniquement 1 à 6 s’il y a lieu, 10.2, 10.3, et 12.9,
6.3 dd) La présente norme uniquement 1 à 6 s’il y a lieu, 10.2, 10.3, et 12.9,
6.3 ee) La présente norme uniquement 1 à 6 s’il y a lieu, 10.2, 10.3, et 12.9,
6.8.2 CEI 60601-1:1988 et 1 à 6 s’il y a lieu, 13.1, à 13.5 s’il y a
CEI 60601-2-13:1998/ISO 8835-1, lieu, parties concernées du 13.6
6.8.2 aa) La présente norme uniquement 1 à 6 s’il y a lieu, 13.1, à 13.5 s’il y a
lieu, parties concernées du 13.6
6.8.2 bb) La présente norme uniquement 1 à 6 s’il y a lieu, 13.1, à 13.5 s’il y a
lieu, parties concernées du 13.6
7 CEI 60601-1:1988 1 à 6 s’il y a lieu
8 CEI 60601-1:1988 1 à 6 s’il y a lieu
9 CEI 60601-1:1988 1 à 6 s’il y a lieu
«à s
...