EN ISO 8835-4:2004
(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)
WIs 107-110 are the result of the splitting of WI 092 - Revision, in parts of EN 740:1998 (CC/000724)
Extension of the DOW for WI 00215108 to DAV + 66 months - Res 440/2002 (NT/030117)
PARTIALLY supersedes EN 740:1998
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 Anästhesiemittelverdampfern (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 Anästhesieatemsystemen (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'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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-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
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
June 2004
ICS 11.040.10
English version
Inhalational anaesthesia systems - Part 4: Anaesthetic vapour
delivery devices (ISO 8835-4:2004)
Systèmes d'anesthésie par inhalation - Partie 4: Dispositifs
d'alimentation en vapeur anesthésique (ISO 8835-4:2004)
This European Standard was approved by CEN on 21 May 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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
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 8835-4:2004: E
worldwide for CEN national Members.
Foreword
This document (EN ISO 8835-4:2004) 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 December 2004, and conflicting
national standards shall be withdrawn at the latest by January 2010.
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 8835-4:2004 has been approved by CEN as EN ISO 8835-4:2004 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.
INTERNATIONAL ISO
STANDARD 8835-4
First edition
2004-06-01
Inhalational anaesthesia systems —
Part 4:
Anaesthetic vapour delivery devices
Systèmes d'anesthésie par inhalation —
Partie 4: Dispositifs d'alimentation en vapeur anesthésique
Reference number
ISO 8835-4:2004(E)
©
ISO 2004
ISO 8835-4:2004(E)
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ISO 8835-4:2004(E)
Contents Page
Foreword. v
Introduction . vi
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 General requirements and general requirements for tests . 2
5 Classification. 2
6 Identification, marking and documents. 2
7 Power input. 4
8 Basic safety categories . 4
9 Removable protective means . 4
10 Environmental conditions. 4
11 Not used. 4
12 Not used. 4
13 General. 4
14 Requirements related to classification . 4
15 Limitation of voltage and/or energy . 5
16 Enclosures and protective covers . 5
17 Separation. 5
18 Protective earthing, functional earthing and potential equalization . 5
19 Continuous leakage currents and patient auxiliary currents . 5
20 Dielectric strength. 5
21 Mechanical strength . 5
22 Moving parts. 5
23 Surfaces, corners and edges. 5
24 Stability in normal use. 5
25 Expelled parts. 5
26 Vibration and noise. 6
27 Pneumatic and hydraulic power. 6
28 Suspended masses. 6
29 X-radiation. 6
30 Alpha, beta, gamma, neutron radiation and other particle radiation. 6
31 Microwave radiation. 6
32 Light radiation (including lasers) . 6
33 Infra-red radiation . 6
ISO 8835-4:2004(E)
34 Ultraviolet radiation.6
35 Acoustical energy (including ultrasonics).6
36 Electromagnetic compatibility .6
37 Locations and basic requirements.7
38 Marking and accompanying documents.7
39 Common requirements for category AP and category APG equipment .7
40 Requirements and tests for category AP equipment, parts and components thereof .7
41 Requirements and tests for category APG equipment, parts and components thereof .7
42 Excessive temperatures .7
43 Fire prevention.7
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility.8
45 Pressure vessels and parts subject to pressure .8
46 Human errors .8
47 Electrostatic charges .8
48 Biocompatibility.8
49 Interruption of the power supply .8
50 Accuracy of operating data .9
51 Protection against hazardous output.9
52 Abnormal o
...
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