SIST EN ISO 8835-4:2005

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.

Systemes 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• Status: Withdrawn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: 31-Dec-2004
• Withdrawal Date: 16-Apr-2009
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 17-Apr-2009
• Due Date: 10-May-2009
• Completion Date: 17-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: EN ISO 8835-4:2004 - Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)

Relations

• Corrected By: SIST EN ISO 8835-4:2005/AC:2006 - Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)
• Effective Date: 22-Dec-2008
• Replaced By: SIST EN ISO 8835-4:2009 - Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)
• Effective Date: 01-Jun-2009
• Corrected By: SIST EN ISO 8835-4:2005/AC:2005 - Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)
• Effective Date: 22-Dec-2008
• Corrected By: SIST EN ISO 8835-4:2005/AC:2005 - Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)
• Effective Date: 08-Jun-2022
• Corrected By: SIST EN ISO 8835-4:2005/AC:2006 - Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)
• Effective Date: 08-Jun-2022
• Replaced By: SIST EN ISO 8835-4:2009 - Inhalational anaesthesia systems - Part 4: Anaesthetic vapour delivery devices (ISO 8835-4:2004)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8835-4:2005
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
SIST EN ISO 8835-4:2005 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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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.

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EN ISO 8835-4:2004 (E)



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.

2

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EN ISO 8835-4:2004 (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.

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.


3

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

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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
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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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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.
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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

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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
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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.
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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.
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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.
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ISO 8835-4:2004(E)
15 Limitation of voltage and/or energy
IEC 60601-1:1988, Clause 15 applies.
16 Enclosures and p
...