SIST EN ISO 8835-5:2004

Inhalational anaesthesia systems - Part 5: Anaesthesia ventilators (ISO 8835-5:2004)

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 00215109 to DAV + 66 months - Res 440/2002 (NT/030117)
PARTIALLY supersedes EN 740:1998

Systeme für die Inhalationsanästhesie - Teil 5: Anästhesie-Beatmungsgeräte (ISO 8835-5:2004)

Es gilt IEC 60601-1:1988, Abschnitt 1 mit folgenden Aunahmen:
Dieser Teil von ISO 8835-5 legt besondere Anforderungen für die wesentliche Leistung von Anästhesie-Beatmungsgeräten (wie in 3.1 definiert) fest. In diesem Teil von ISO 8835 behandelte Anästhesie-Beatmungsgeräte sind immer ein Bestandteil eines Anästhesiesystems und dazu vorgesehen, ununterbrochen durch einen Anwender überwacht zu werden.
Dieser Teil von ISO 8835 gilt nicht für Anästhesie-Beatmungsgeräte, die für die Verwendung mit brennbaren Anästhesiemitteln bestimmt sind, wie in Anhang BB festgelegt.
Es ist davon auszugehen, dass 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, Vorrang vor den entsprechenden allgemeinen Anforderungen haben.

Systemes d'anesthésie par inhalation - Partie 5: Ventilateurs d'anesthésie (ISO 8835-5:2004)

Inhalacijski anestezijski sistemi – 5. del: Anestezijski ventilatorji (ISO 8835-5:2004)

General Information

• Status: Withdrawn
• Publication Date: 31-Oct-2004
• Withdrawal Date: 10-May-2009
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 11-May-2009
• Due Date: 03-Jun-2009
• Completion Date: 11-May-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 8835-5:2004 - Inhalational anaesthesia systems - Part 5: Anaesthesia ventilators (ISO 8835-5:2004)

Relations

• Corrected By: SIST EN ISO 8835-5:2004/AC:2005 - Inhalational anaesthesia systems - Part 5: Anaesthesia ventilators (ISO 8835-5:2004)
• Effective Date: 22-Dec-2008
• Replaced By: SIST EN ISO 8835-5:2009 - Inhalational anaesthesia systems - Part 5: Anaesthesia ventilators (ISO 8835-5:2004)
• Effective Date: 01-Jun-2009
• Corrected By: SIST EN ISO 8835-5:2004/AC:2006 - Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)
• Effective Date: 22-Dec-2008
• Corrected By: SIST EN ISO 8835-5:2004/AC:2006 - Inhalational anaesthesia systems - Part 5: Anaesthetic ventilators (ISO 8835-5:2004)
• Effective Date: 08-Jun-2022
• Corrected By: SIST EN ISO 8835-5:2004/AC:2005 - Inhalational anaesthesia systems - Part 5: Anaesthesia ventilators (ISO 8835-5:2004)
• Effective Date: 08-Jun-2022
• Replaces: SIST EN 740:2000/AC:2000 - Anaesthetic workstations and their modules - Particular requirements
• Effective Date: 01-Nov-2004
• Replaces: SIST EN 740:2000 - Anaesthetic workstations and their modules - Particular requirements
• Effective Date: 01-Nov-2004

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 8835-5:2004
01-november-2004
1DGRPHãþD
SIST EN 740:2000
SIST EN 740:2000/AC:2000
Inhalacijski anestezijski sistemi – 5. del: Anestezijski ventilatorji (ISO 8835-5:2004)
Inhalational anaesthesia systems - Part 5: Anaesthesia ventilators (ISO 8835-5:2004)
Systeme für die Inhalationsanästhesie - Teil 5: Anästhesie-Beatmungsgeräte (ISO 8835-
5:2004)
Systemes d'anesthésie par inhalation - Partie 5: Ventilateurs d'anesthésie (ISO 8835-
5:2004)
Ta slovenski standard je istoveten z: EN ISO 8835-5:2004
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 8835-5:2004 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 8835-5:2004

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SIST EN ISO 8835-5:2004



EUROPEAN STANDARD
EN ISO 8835-5

NORME EUROPÉENNE

EUROPÄISCHE NORM
May 2004
ICS 11.040.10 Supersedes EN 740:1998
English version
Inhalational anaesthesia systems - Part 5: Anaesthesia
ventilators (ISO 8835-5:2004)
Systèmes d'anesthésie par inhalation - Partie 5: Systeme für die Inhalationsanästhesie - Teil 5: Anästhesie-
Ventilateurs d'anesthésie (ISO 8835-5:2004) Beatmungsgeräte (ISO 8835-5:2004)
This European Standard was approved by CEN on 6 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 8835-5:2004: E
worldwide for CEN national Members.

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SIST EN ISO 8835-5:2004

EN ISO 8835-5:2004 (E)





Foreword


This document (EN ISO 8835-5:2004) 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 November 2004, and conflicting national
standards shall be withdrawn at the latest by November 2009.

This document supersedes EN 740:1998.

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 8835-5:2004 has been approved by CEN as EN ISO 8835-5:2004 without any
modifications.

2

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SIST EN ISO 8835-5:2004

EN ISO 8835-5:2004 (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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SIST EN ISO 8835-5:2004

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SIST EN ISO 8835-5:2004


INTERNATIONAL ISO
STANDARD 8835-5
First edition
2004-05-15


Inhalational anaesthesia systems —
Part 5:
Anaesthetic ventilators
Systèmes d'anesthésie par inhalation —
Partie 5: Ventilateurs d'anesthésie




Reference number
ISO 8835-5:2004(E)
©
ISO 2004

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SIST EN ISO 8835-5:2004
ISO 8835-5:2004(E)
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ii © ISO 2004 – All rights reserved

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SIST EN ISO 8835-5:2004
ISO 8835-5:2004(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 . 3
5 Classification. 3
6 Identification, marking and documents. 3
7 Power input. 5
8 Basic safety categories . 6
9 Removable protective means . 6
10 Environmental conditions. 6
11 Not used. 6
12 Not used. 6
13 General. 6
14 Requirements related to classification . 6
15 Limitation of voltage and/or energy . 6
16 Enclosures and protective covers . 6
17 Separation. 6
18 Protective earthing, functional earthing and potential equalization . 6
19 Continuous leakage currents and patient auxiliary currents . 7
20 Dielectric strength. 7
21 Mechanical strength . 7
22 Moving parts. 7
23 Surfaces, corners and edges. 7
24 Stability in normal use. 7
25 Expelled parts. 7
26 Vibration and noise. 7
27 Pneumatic and hydraulic power. 7
28 Suspended masses. 7
29 X-Radiation . 7
30 Alpha, beta, gamma, neutron radiation and other particle radiation. 8
31 Microwave radiation. 8
32 Light radiation (including lasers) . 8
33 Infra-red radiation . 8
© ISO 2004 – All rights reserved iii

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SIST EN ISO 8835-5:2004
ISO 8835-5:2004(E)
34 Ultraviolet radiation.8
35 Acoustical energy (including ultrasonics).8
36 Electromagnetic compatibility .8
37 Locations and basic requirements.8
38 Marking and accompanying documents.8
39 Common requirements for category AP and category APG equipment .8
40 Requirements and tests for category AP equipment, parts and components thereof .9
41 Requirements and tests for category APG equipment, parts and components thereof .9
42 Excessive temperatures .9
43 Fire prevention.9
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization,
disinfection and compatibility.9
45 Pressure vessels and parts subject to pressure .10
46 Human errors .10
47 Electrostatic charges .10
48 Biocompatibility.10
49 Interruption of the power supply .10
50 Accuracy of operating data .10
51 Protection against hazardous output.10
52 Abnormal operation and fault conditions.11
53 Environmental tests .11
54 General .11
55 Enclosures and covers .11
56 Components and general assembly.11
57 Mains parts, components and layout.12
58 Protective earthing — Terminals and connections .12
59 Construction and layout .12
101 Additional requirements for anaesthetic ventilators.12
102 Appendices of IEC 60601-1:1988 .13
Annex AA (informative) Rationale .14
Annex BB (normative) Test for flammability of anaesthetic agents.15
Bibliography.16

iv © ISO 2004 – All rights reserved

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SIST EN ISO 8835-5:2004
ISO 8835-5:2004(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 8835-5 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, Medical electrical equipment — Part 1: Particular requirements for the safety of anaesthetic
workstations, was withdrawn in 1998 and replaced by the second edition of IEC 60601-2-13, Medical electrical
equipment — Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems.
© ISO 2004 – All rights reserved v

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SIST EN ISO 8835-5:2004
ISO 8835-5:2004(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 Definitions of Collateral Standard and Particular Standard 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 an existing element 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: 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;
 description of type of document change, and test methods: italic type;
 terms defined in the General Standard IEC 60601-1:1988, Clause 2 and terms defined in this part of
ISO 8835: bold type.
Throughout this part of ISO 8835, text for which a rationale is provided in Annex AA is indicated by an asterisk
∗
( ).

vi © ISO 2004 – All rights reserved

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SIST EN ISO 8835-5:2004
INTERNATIONAL STANDARD ISO 8835-5:2004(E)

Inhalational anaesthesia systems —
Part 5:
Anaesthetic ventilators
1 Scope
IEC 60601-1:1988, Clause 1 applies except as follows:
This part of ISO 8835 specifies particular requirements for the essential performance of anaesthetic
ventilators (as defined in 3.1). This part of ISO 8835 is applicable to anaesthetic ventilators which are
always a component of an anaesthetic system and are intended to be continuously attended by an operator.
This part of ISO 8835 is not applicable to anaesthetic ventilators intended for use with flammable
anaesthetics, as determined by Annex BB.
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 407, Small medical gas cylinders — Pin-index yoke-type valve connections
ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary
ISO 5145, Cylinder valve outlets for gases and gas mixtures — Selection and dimensioning
ISO 5356-1, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets
ISO 5356-2, Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded
weight-bearing connectors
ISO 5359, Low-pressure hose assemblies for use with medical gases
ISO 7396-1, Medical gas pipeline systems — Part 1: Pipelines for compressed medical gases and vacuum
ISO 8835-2:1999, Inhalational anaesthesia systems — Part 2: Anaesthetic breathing systems for adults
ISO 8835-3:1997, Inhalational anaesthesia systems — Part 3: Anaesthetic gas scavenging systems —
Transfer and receiving systems
ISO 10524, Pressure regulators and pressure regulators with flow-metering devices for medical gas systems
© ISO 2004 – All rights reserved 1

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SIST EN ISO 8835-5:2004
ISO 8835-5:2004(E)
IEC 60079-4:1975, Electrical apparatus for explosive gas atmospheres — Part 4: Method of test for ignition
temperature
EC 60079-11:1999, Electrical apparatus for explosive gas atmospheres — Part 11: Intrinsic safety “i”
IEC 60601-1:1988, Medical electrical equipment — Part 1: General requirements for safety
IEC 60601-1-2:2001, Medical electrical equipment — Part 1-2: General requirements for safety — Collateral
standard: Electromagnetic compatibility — Requirements and tests
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 part of ISO 8835, the terms and definitions given in IEC 60601-1, ISO 4135 and
IEC 60601-2-13 and the following apply.
3.1
anaesthetic ventilator
lung ventilator designed for use during anaesthesia with an anaesthetic breathing system
3.2
breathing system connection port
port which connects the ventilator to the breathing system
3.3
legible
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.
3.4
driving gas
gas which powers the ventilator but is not delivered to the patient
3.5
driving gas inlet port
port to which the driving gas is supplied
3.6
inflating gas
gas delivered to the patient's airway which is controlled by the anaesthetic ventilator
NOTE The inflating gas may also power the anaesthetic ventilator.
3.7
inflating gas inlet port
port to which the inflating gas is supplied
3.8
maximum limited pressure
p
LIM max
highest pressure at the patient connection port during normal use and under a single fault condition
NOTE Adapted from IEC 60601-2-12.
2 © ISO 2004 – All rights reserved

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SIST EN ISO 8835-5:2004
ISO 8835-5:2004(E)
3.9
minimum limited pressure
p
LIM min
lowest pressure at the patient connection port during normal use and under a single fault condition
NOTE 1 Adapted from IEC 60601-2-12.
NOTE 2 This pressure may be sub-atmospheric.
3.10
maximum working pressure
p
W max
highest pressure which can be attained at the patient connection port during the inspiratory phase, with the
ventilator operating normally
[ISO 4135]
3.11
minimum working pressure
p
W min
lowest (most negative) pressure which can be attained at the patient connection port during the expiratory
phase, with the ventilator operating normally
[ISO 4135]
3.12
oxygen-rich environment
environment in which the partial pressure of oxygen is greater than 275 hPa
4 General requirements and general requirements for tests
IEC 60601-1:1988, 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 Clause 6 applies, except as follows.
6.1 Marking on the outside of equipment or equipment parts
Additions:
aa) If provided and operator-accessible, the following ports shall be legibly and durably marked:
 driving gas inlet port;
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SIST EN ISO 8835-5:2004
ISO 8835-5:2004(E)
 driving gas exhaust port;
 inflating gas inlet port;
 fresh gas inlet;
 anaesthetic breathing system connection port;
 inspiratory port;
 expiratory port;
 exhaust port;
 bag port.
6.3 Marking of controls and instruments
Addition:
aa) The operator-adjustable means for pressure limitation shall be graduated in units or multiples of pascals
and/or centimetres water.
6.8.2 Instructions for use
Additions:
aa) The instructions for use of the anaesthetic ventilator, shall contain a statement to the effect that the
anaesthetic ventilator is intended to be used with
1) an anaesthetic breathing system in accordance with ISO 8835-2, and
2) an anaesthetic gas scavenging transfer and receiving system in accordance with ISO 8835-3.
Unless the anaesthetic ventilator is an integral part of an anaesthetic system, the manufacturer/supplier of
the anaesthetic ventilator shall provide information on how to connect the anaesthetic breathing system
and the anaesthetic gas scavenging transfer and receiving system.
bb) The manufacturer/supplier of an anaesthetic ventilator shall provide the following information:
1) an instruction on how to perform a leak test of the anaesthetic ventilator;
2) the supply pressure range required for the driving gas(es) of the anaesthetic ventilator;
3) set-up, gas flow(s) and technique recommended for testing the anaesthetic ventilator before use;
4) a warning that the anaesthetic ventilator is not intended to be used with flammable anaesthetic
agents;
5) inspiratory flow and pressure characteristics.
cc) The instructions for use shall contain a statement to the e
...