EN ISO 8835-4:2009

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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 8835-4:2004 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
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.
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
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
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
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
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
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.
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
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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ii © ISO 2004 – All rights reserved

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 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

ISO 8835-4:2004(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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 identifying any or all such patent rights.
ISO 8835-4 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 1, Breathing attachments and anaesthetic machines.
ISO 8835 consists of the following parts, under the general title Inhalational anaesthesia systems:
— Part 2: Anaesthetic breathing systems for adults
— Part 3: Anaesthetic gas scavenging systems — Transfer and receiving systems
— Part 4: Anaesthetic vapour delivery devices
— Part 5: Anaesthetic ventilators
NOTE ISO 8835-1 was withdrawn and has been revised as IEC 60601-2-13:2003, Medical electrical equipment —
Part 2-13, Particular requirements for the safety and essential performance of anaesthetic systems.
ISO 8835-4:2004(E)
Introduction
This part of ISO 8835 is a Particular Standard based on IEC 60601-1:1988, including Amendments 1 (1991)
and 2 (1995), hereafter referred to as the General Standard. The General Standard is the basic standard for
the safety of all medical electrical equipment used by or under the supervision of qualified personnel in the
general medical and patient environment; it also contains certain requirements for reliable operation to ensure
safety.
The General Standard has associated Collateral Standards and Particular Standards. The Collateral
Standards include requirements for specific technologies and/or hazards and apply to all applicable equipment,
such as medical systems, EMC, radiation protection in diagnostic X-ray equipment, software, etc. The
Particular Standards apply to specific equipment types, such as medical electron accelerators, high frequency
surgical equipment, hospital beds, etc.
NOTE 1 Definitions of Collateral Standards and Particular Standards can be found in IEC 60601-1:1988, 1.5 and A.2,
respectively.
To facilitate the use of this part of ISO 8835, the following drafting conventions have been applied.
This part of ISO 8835 uses the same main clause titles and numbering as the General Standard, for ease of
cross-referencing of the requirements. The changes to the text of the General Standard [ as supplemented by
the Collateral Standards], are specified by the use of the following words.
 “Replacement” means that the indicated clause or subclause of the General Standard is replaced
completely by the text of this Particular Standard.
 “Addition” means that the relevant text of this Particular Standard is a new element (e.g. subclause, list
item, note, table, figure) additional to the General Standard.
 “Amendment” means that existing text of the General Standard is partially modified by deletion and/or
addition as indicated by the text of this Particular Standard.
To avoid confusion with any amendments to the General Standard itself, a particular numbering has been
employed for elements added by this part of ISO 8835: clauses, subclauses, tables and figures are numbered
starting from 101; additional list items are lettered aa), bb), etc. and additional annexes are lettered AA, BB,
etc.
In this part of ISO 8835, the following print types are used:
 requirements, compliance with which can be verified, and definitions: roman type;
 notes and examples: smaller roman type;
 test methods: italic type;
 terms defined in the General Standard IEC 60601-1:1988, Clause 2, or in this Particular Standard: bold
type.
Throughout this International Standard, text for which a rationale is provided in Annex AA is indicated by an
asterisk (*).
NOTE 2 Attention is drawn to ISO/TS 18835 concerning draw-over vaporizers.

vi © ISO 2004 – All rights reserved

INTERNATIONAL STANDARD ISO 8835-4:2004(E)

Inhalational anaesthesia systems —
Part 4:
Anaesthetic vapour delivery devices
1 Scope
IEC 60601-1:1988, Clause 1 applies except as follows.
Addition:
This part of ISO 8835 specifies particular requirements for the essential performance of anaesthetic vapour
delivery devices (AVDDs), as defined in 3.1. This part of ISO 8835 is applicable to AVDDs which are a
component of an anaesthetic system and are intended to be continuously operator-attended. This part of
ISO 8835 gives specific requirements for AVDDs which are supplementary to the applicable general
requirements in IEC 60601-2-13.
This part of ISO 8835 is not applicable to AVDDs intended for use with flammable anaesthetics, as
determined by Annex CC, and AVDDs intended for use within anaesthetic breathing systems (e.g. draw-over
vaporizers).
The requirements of this part of ISO 8835 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.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 4135, Anaesthetic and respiratory equipment — Vocabulary
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 5360, Anaesthetic vaporizers — Agent-specific filling systems
ISO 8835-3, Inhalational anaesthesia systems — Part 3: Anaesthetic gas scavenging systems — Transfer
and receiving systems
ISO 11196, Anaesthetic gas monitors
IEC 60079-4, Electrical apparatus for explosive gas atmospheres. Part 4: Method of test for ignition
temperature
IEC 60079-11, Electrical apparatus for explosive gas atmospheres — Part 11: Intrinsic safety “i”
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety
ISO 8835-4:2004(E)
IEC 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for safety — Collateral
standard: Electromagnetic compatibility — Requirements and tests
IEC 60601-1-6, Medical electrical equipment — Part 1-6: General requirements for safety — Collateral
standard: Usability
IEC 60601-2-13:2003, Medical electrical equipment — Part 2-13: Particular requirements for the safety and
essential performance of anaesthetic systems
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 4135, IEC 60601-2-13 and the
following apply.
3.1
anaesthetic vapour delivery device
AVDD
device which provides the vapour of an anaesthetic agent in a controllable concentration
3.2
legible
property of displayed qualitative or quantitative information, values, functions and markings that can be
discriminated and identified under a specific set of environmental conditions
NOTE See 6.101 for testing for legibility.
4 General requirements and general requirements for tests
IEC 60601-1:1998, Clauses 3 and 4 apply, except as follows
Addition:
4.101 Other test methods
Test methods other than those specified in this part of ISO 8835, but of equal or greater accuracy, may be
used to verify compliance with requirements.
5 Classification
IEC 60601-1:1988, Clause 5 applies.
6 Identification, marking and documents
IEC 60601-2-13:2003, Clause 6 applies, except as follows.
Additions:
6.1 aa) The AVDD shall be labelled with the words “before use read instructions for use”, or Symbol #14 from
IEC 60601-1:1988, Table D.1.
2 © ISO 2004 – All rights reserved

ISO 8835-4:2004(E)
6.3 Marking of controls and instruments
Additions:
aa) Controls for anaesthetic vapour output shall be marked with an indication how to increase vapour output.
(See 101.3 for rotary controls)
bb) Either the maximum and minimum filling levels shall be marked on the liquid level indicator, or the actual
usable volume shall be displayed.
cc) The filling port shall be marked with the generic name of the anaesthetic agent. The control activating the
delivery of a specific anaesthetic agent shall be marked with the generic name in full spelling or in
abbreviated form as given in the following list:
 Desflurane: “DES”
 Enflurane: “ENF”
 Halothane: “HAL”
 Isoflurane: “ISO”
 Sevoflurane: “SEV”
If colour coding is used, it shall be in accordance with Annex BB.
dd) The units in which the control of the AVDD is graduated shall be indicated.
ee) Graduated controls shall be marked with “0” or “Off”, or with both if the “0” position is not also the “Off”
position, or with “Standby” if the “Off” position is not provided.
NOTE If the AVDD is set at “Off” or “Standby”, no anaesthetic vapour is intentionally being added to the output flow.
“Standby” set on an electrically operated AVDD indicates that the AVDD is enabled. “0” setting indicates that no more than
the manufacturer's prescribed tolerance of anaesthetic vapour is being added to the output flow.
6.8.2 Instructions for use
Additions:
aa) The instructions for use of the AVDD shall contain a statement to the effect that the AVDD is intended to
be used with
 an anaesthetic agent monitor complying with ISO 11196, and
 an anaesthetic gas scavenging transfer and receiving system in accordance with ISO 8835-3.
bb) The instructions for use of the AVDD shall contain
1) instructions for fitting the AVDD, if appropriate,
2) the performance of the AVDD, if applicable, including the effects of variation in ambient temperature,
ambient pressure, resistance to flow, tilting, back-pressure, sub-atmospheric pressure, input flow and
gas mixture over the range of operating conditions specified by the manufacturer,
3) instructions for filling the AVDD,
4) the volume of anaesthetic agent required to fill the reservoir of the AVDD from the minimum to the
maximum filling level, and the total capacity,
NOTE The anaesthetic agent bottle can be used as the anaesthetic agent reservoir.
ISO 8835-4:2004(E)
5) if the AVDD should not be used at a setting between “Off” and the first graduation above zero, a
statement to this effect,
6) the carrier gas, gas flowrate(s) and analytical technique(s) recommended for measuring the output of
the AVDD,
7) advice on handling, transportation and storage.
6.101 Test method for legibility
Legible indications shall be correctly perceived by an operator with a visual acuity of 0 on the log MAR scale
or 66 (20/20) vision (corrected if necessary) from a distance of 1 m ± 10 % at a light level of 215 lux ± 65 lux,
when viewing the information, markings, etc. perpendicular to and including 15° above, below, left and right of
the normal line of sight of the operator.
7 Power input
IEC 60601-1:1988, Clause 7 applies.
8 Basic safety categories
IEC 60601-1:1988, Clause 8 applies.
9 Removable protective means
IEC 60601-1:1988, Clause 9 applies.
10 Environmental conditions
IEC 60601-1:1988, Clause 10 applies.
11 Not used
IEC 60601-1:1988, Clause 11 applies.
12 Not used
IEC 60601-1:1988, Clause 12 applies.
13 General
IEC 60601-1:1988, Clause 13 applies.
14 Requirements related to classification
IEC 60601-1:1988, Clause 14 applies.
4 © ISO 2004 – All rights reserved

ISO 8835-4:2004(E)
15 Limitation of voltage and/or energy
IEC 60601-1:1988, Clause 15 applies.
16 Enclosures and protective covers
IEC 60601-1:1988, Clause 16 applies.
17 Separation
IEC 60601-1:1988, Clause 17 applies.
18 Protective earthing, functional earthing and potential equalization
IEC 60601-1:1988, Clause 18 applies.
19 Continuous leakage currents and patient auxiliary currents
IEC 60601-1:1988, Clause 19 applies.
20 Dielectric strength
IEC 60601-1:1988, Clause 20 applies.
21 Mechanical strength
IEC 60601-1:1988, Clause 21 applies.
22 Moving parts
IEC 60601-1:1988, Clause 22 applies.
23 Surfaces, corners and edges
IEC 60601-1:1988, Clause 23 applies.
24 Stability in normal use
IEC 60601-1:1988, Clause 24 applies.
25 Expelled parts
IEC 60601-1:1988, Clause 25 applies.
ISO 8835-4:2004(E)
26 Vibration and noise
IEC 60601-1:1988, Clause 26 applies.
27 Pneumatic and hydraulic power
IEC 60601-1:1988, Clause 27 applies.
28 Suspended masses
IEC 60601-1:1988, Clause 28 applies.
29 X-radiation
IEC 60601-1:1988, Clause 29 applies.
30 Alpha, beta, gamma, neutron radiation and other particle radiation
IEC 60601-1:1988, Clause 30 applies.
31 Microwave radiation
IEC 60601-1:1988, Clause 31 applies.
32 Light radiation (including lasers)
IEC 60601-1:1988, Clause 32 applies.
33 Infra-red radiation
IEC 60601-1:1988, Clause 33 applies.
34 Ultraviolet radiation
IEC 60601-1:1988, Clause 34 applies.
35 Acoustical energy (including ultrasonics)
IEC 60601-1:1988, Clause 35 applies.
36 Electromagnetic compatibility
IEC 60601-1:1988, Clause 36 applies, except as follows:
Addition:
IEC 60601-1-2:2001 applies.
6 © ISO 2004 – All rights reserved

ISO 8835-4:2004(E)
37 Locations and basic requirements
IEC 60601-1:1988, Clause 37 does not apply.
38 Marking and accompanying documents
IEC 60601-1:1988, Clause 38 does not apply.
39 Common requirements for category AP and category APG equipment
IEC 60601-1:1988, Clause 39 does not apply.
NOTE AP = anaesthetic proof, APG = anaesthetic proof gas.
40 Requirements and tests for category AP equipment, parts and components
thereof
IEC 60601-1:1988, Clause 40 does not apply.
41 Requirements and tests for category APG equipment, parts and components
thereof
IEC 60601-1:1988, Clause 41 does not apply.
42 Excessive temperatures
IEC 60601-1:1988, Clause 42 applies.
43 Fire prevention
IEC 60601-1:1988, Clause 43 applies, except as follows.
Addition:
* In order to reduce the risk to patients, other persons or the surroundings due to fire, ignitable material in an
oxygen-rich environment, under normal and single fault conditions, shall not at the same time be
subjected to conditions in which
 the temperature of the material is raised to its minimum ignition temperature, and
 an oxidant is present.
The minimum ignition temperature shall be determined in accordance with IEC 60079-4 using the oxidizing
conditions present under normal and single fault conditions.
Compliance is checked by determining the temperature to which the material is raised under normal and
single fault conditions.
If sparking can occur under normal or single fault condition(s), the material subjected to the
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