SIST EN ISO 8835-4:2009

SLOVENSKI STANDARD
SIST EN ISO 8835-4:2009
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
SIST EN ISO 8835-4:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8835-4:2009

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SIST EN ISO 8835-4:2009
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.

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SIST EN ISO 8835-4:2009
EN ISO 8835-4:2009 (E)
Contents Page
Foreword .3
Annex ZA (Informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

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SIST EN ISO 8835-4:2009
EN ISO 8835-4:2009 (E)
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
EN ISO 8835-4:2009 by 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 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.
3

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SIST EN ISO 8835-4:2009
EN ISO 8835-4:2009 (E)
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
1
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
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SIST EN ISO 8835-4:2009
EN ISO 8835-4:2009 (E)

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
5

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SIST EN ISO 8835-4:2009
EN ISO 8835-4:2009 (E)

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
6

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SIST EN ISO 8835-4:2009
EN ISO 8835-4:2009 (E)

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
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SIST EN ISO 8835-4:2009
EN ISO 8835-4:2009 (E)

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.
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SIST EN ISO 8835-4:2009
EN ISO 8835-4:2009 (E)
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
requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific than those
of Directive 93/42/EEC along with the corresponding clauses of this European Standard. Table ZA.2,
however, does not imply any citation in the OJEU under the machinery directive and thus does not provide
presumption of conformity for the machinery directive.
Table ZA.2 – Relevant Essential Requirements from Directive 2006/42/EC on
machinery that are addressed by this European Standard
(according to article 3 of amended Directive 93/42/EEC)

Clause(s)/sub-clause(s) of this Essential Health and Safety Qualifying remarks/Notes
EN Requirements (EHSRs) of
Directive 2006/42/EC
- 1.1.4 This relevant Essential
Requirement is not addressed
in this EN
51.102, 101 1.2.2 This relevant Essential
Requirement is not fully
addressed in this EN
6.3, 101.1 1.5.4 This relevant Essential
Requirement is not fully
addressed in this EN
- 1.6.1 This relevant Essential
Requirement is not completely
addressed in this EN; see also
reference to IEC 60601-1
- 1.6.2 This relevant Essential
Requirement is not addressed
in this EN
- 1.6.3 This relevant Essential
Requirement is not completely
addressed in this EN; see
reference to IEC 60601-1
- 3.6.2 This relevant Essential
Requirement is not completely
addressed in this EN; see
reference to IEC 60601-1




9

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SIST EN ISO 8835-4:2009

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SIST EN ISO 8835-4:2009


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

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SIST EN ISO 8835-4:2009
ISO 8835-4:2004(E)
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ii © ISO 2004 – All rights reserved

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SIST EN ISO 8835-4:2009
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 2004 – All rights reserved iii

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SIST EN ISO 8835-4:2009
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 operation and fault conditions.10
53 Environmental tests .11
54 General .11
55 Enclosures and covers .11
56 Components and general assembly.11
57 Mains parts, components and layout.11
58 Protective earthing — Terminals and connections .11
59 Construction and layout .11
101 Additional requirements for AVDDs.11
102 Appendices of IEC 60601-1:1988 .12
Annex AA (informative) Rationale .13
Annex BB (informative) Recommended colours for colour coding of anaesthetic vapour delivery
devices .16
Annex CC (normative) Test for flammability of anaesthetic agents.17
Bibliography.18

iv © ISO 2004 – All rights reserved

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SIST EN ISO 8835-4:2009
ISO 8835-4:2004(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
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Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifyin
...