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CEN

EN ISO 8835-4:2004/AC:2006

(Corrigendum)

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)

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

Systeme für die Inhalationsanästhesie - Teil 4: Anästhesiemittelverdampfer (ISO 8835-4:2004)

Systèmes d'anesthésie par inhalation - Partie 4: Dispositifs d'alimentation en vapeur anesthésique (ISO 8835-4:2004)

Sistemi za inhalacijsko anestezijo – 4. del: Naprave za dovajanje anestezijskih hlapov (hlapilniki) (ISO 8835-4:2004)

General Information

Status
Withdrawn
Publication Date
24-Jan-2006
Withdrawal Date
07-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/WG 1 - Anaesthetic machines, medical breathing systems and anaesthetic gas scavenging systems
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
08-Apr-2009
Completion Date
08-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 8835-4:2005/AC:2006 - Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)

Relations

Replaces
EN ISO 8835-4:2004/AC:2004 - Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)
Effective Date
22-Dec-2008
Replaced By
EN ISO 8835-4:2009 - Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)
Effective Date
01-Apr-2009
Corrects
EN ISO 8835-4:2004 - Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)
Effective Date
08-Jun-2022

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EN ISO 8835-4:2005/AC:2006EN ISO 8835-4:2005/AC:2006
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Corrigendum
EN ISO 8835-4:2005/AC:2006
English and German language
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Standards Content (Sample)


SLOVENSKI STANDARD
01-april-2006
1DGRPHãþD
SIST EN ISO 8835-4:2005/AC:2005
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)
Systemes d'anesthésie par inhalation - Partie 4: Dispositifs d'alimentation en vapeur
anesthésique (ISO 8835-4:2004)
Ta slovenski standard je istoveten z: EN ISO 8835-4:2004/AC:2006
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 8835-4:2004/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 4: Anaesthetic vapour delivery
devices (ISO 8835-4:2004)
Systèmes d'anesthésie par inhalation - Systeme für die Inhalationsanästhesie - Teil
Partie 4: Dispositifs d'alimentation en 4: Anästhesiemittelverdampfer (ISO 8835-
vapeur anesthésique (ISO 8835-4:2004) 4:2004)
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 8835-4:2004/AC:2006 D/E/F

English version
Title page
The following note is to be added: “Partially supersedes EN 740:1998”

Foreword
The following sentence is to be added: “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,
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,
Corresponding paragraph of EEC
Clauses Where located Comment
Directive 93/42/EEC
of this
Standard
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
25 IEC 60601-1: 1988 1 to 6 as applicable, 9.2. 1st dash,
12.7.1
Corresponding paragraph of EEC
Clauses Where located Comment
Directive 93/42/EEC
of this
Standard
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
50 IEC 60601-1: 1988 1 to 6 as applicable
Corresponding paragraph of EEC
Clauses Where located Comment
Directive 93/42/EEC
of this
Standard
51 IEC 60601-1: 1988 1 to 6 as applicable,
51.101 This Standard only 1 to 6 a
...

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This document specifies requirements for anaesthetic reservoir bags for use with anaesthetic and ventilator breathing systems. It includes requirements for the design of the neck, size designation and elasticity.
This document is not applicable to special-purpose bags, for example bellows, self-inflating bags and bags for use with anaesthetic gas scavenging systems.
The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190). All the common requirements that appear in the general standard for airway devices have been removed from this document.

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CEN
EN ISO 16571:2024(Main)
Systems for evacuation of plume generated by medical devices (ISO 16571:2024)
SIST EN ISO 16571:2024

This document specifies requirements and guidelines for systems and equipment used to evacuate plume generated by medical devices.
 This document applies to all types of plume evacuation systems (PESs), including
a)       portable;
b)       mobile;
c)        stationary, including dedicated central pipelines;
d)       PESs integrated into other equipment;
e)       PESs for endoscopic procedures (e.g., minimally invasive, laparoscopic)
This document applies to all healthcare facilities where PESs are used, including, but not limited to
a)       surgical facilities;
b)       medical offices;
c)        cosmetic treatment facilities;
d)       medical teaching facilities;
e)       dental clinics;
f)         veterinary facilities.
This document provides guidance on the following aspects of PESs:
a)       importance;
b)       purchasing;
c)        design;
d)       manufacture;
e)       documentation;
f)         function;
g)       performance;
h)       installation;
i)         commissioning;
j)         testing;
k)       training;
l)         use;
m)     risk assessment;
n)       servicing;
o)       maintenance.
This document does not apply to the following:
a)       anaesthetic gas scavenging systems (AGSSs) which are covered in ISO 7396-2;
b)       medical vacuum systems which are covered in ISO 7396-1;
c)        heating, ventilation, and air-conditioning (HVAC) systems;
d)       aspects of laser safety other than airborne contamination; and
e)       aspects of electrosurgery, electrocautery, and mechanical surgical tools other than airborne contamination produced by such equipment resulting from interaction with tissue or materials.

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EN ISO 15002:2024(Main)
Flow control devices for connection to a medical gas supply system (ISO 15002:2023)
SIST EN ISO 15002:2024

This document specifies requirements for flow control devices that can be connected by the user either directly, by means of a probe or a gas-specific connector, or indirectly by means of a low-pressure hose assembly conforming with ISO 5359 to:
a)    a terminal unit conforming with ISO 9170-1 of a medical gas pipeline system conforming with ISO 7396-1:2016;
b)    the pressure outlet of a regulator conforming with ISO 10524-1:2018; or
c)    to the pressure outlet of a valve integrated pressure regulator (VIPR) conforming with ISO 10524-3 (see 5.2 gas inlets).
This document applies to the following types of flow control devices (FCDs):
a)    flowmeters;
b)    flowgauge FCDs; and
c)    fixed orifice FCDs.
NOTE       Flow control devices that are classed as medical electrical equipment can be subject to additional requirements of IEC 60601-1.
This document applies to flow control devices for the following gases:
—    oxygen;
—    oxygen 93 %;
—    nitrous oxide;
—    medical air;
—    carbon dioxide;
—    oxygen/nitrous oxide mixture 50/50 (% volume fraction);
—    oxygen-enriched air;
—    helium;
—    xenon; and
—    specified mixtures of the gases listed above.
NOTE Flow control devices can be available for other gases.
This document does not apply to flow control devices that are:
a)    for use with gases for driving surgical tools;
b)    an integral part of a regulator (see ISO 10524-1:2018); or
c)           an integral part of a valve with integrated pressure regulator (VIPR) (see ISO 10524-3).

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CEN
EN ISO 80601-2-55:2018/A1:2023(Amendment)
Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors - Amendment 1 (ISO 80601-2-55:2018/Amd 1:2023)
SIST EN ISO 80601-2-55:2018/A1:2024
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