SIST EN 60601-2-13:2006

SLOVENSKI SIST EN 60601-2-13:2006

STANDARD
oktober 2006
Medicinska električna oprema – 2-13. del: Posebne varnostne zahteve in
bistvene lastnosti sistemov za anestezijo (IEC 60601-2-13:2003)
Medical electrical equipment – Part 2-13: Particular requirements for the safety and
essential performance of anaesthetic systems (IEC 60601-2-13:2003)
ICS 11.040.10 Referenčna številka
SIST EN 60601-2-13:2006(en)
©  Standard je založil in izdal Slovenski inštitut za standardizacijo. Razmnoževanje ali kopiranje celote ali delov tega dokumenta ni dovoljeno

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EUROPEAN STANDARD
EN 60601-2-13

NORME EUROPÉENNE
June 2006
EUROPÄISCHE NORM

ICS 11.040.10


English version


Medical electrical equipment
Part 2-13: Particular requirements
for the safety and essential performance
of anaesthetic systems
(IEC 60601-2-13:2003)


Appareils électromédicaux  Medizinische elektrische Geräte
Partie 2-13: Règles particulières de Teil 2-13: Besondere Festlegungen
sécurité et performance essentielle für die Sicherheit von
pour les systèmes d'anesthésie Anästhesiesystemen
(CEI 60601-2-13:2003) (IEC 60601-2-13:2003)




This European Standard was approved by CENELEC on 2006-05-01. CENELEC 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 CENELEC 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 CENELEC member into its own language and notified
to the Central Secretariat has the same status as the official versions.

CENELEC members are the national electrotechnical committees of Austria, Belgium, Cyprus, the Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.

CENELEC
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung

Central Secretariat: rue de Stassart 35, B - 1050 Brussels


© 2006 CENELEC - All rights of exploitation in any form and by any means reserved worldwide for CENELEC members.
Ref. No. EN 60601-2-13:2006 E

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EN 60601-2-13:2006 - 2 -
Foreword
The text of the International Standard IEC 60601-2-13:2003, prepared by SC 62D, Electromedical
equipment, of IEC TC 62, Electrical equipment in medical practice, and ISO TC 121/SC 1, Breathing
attachments and anaesthetic machines, was submitted to the Unique Acceptance Procedure and was
approved by CENELEC as EN 60601-2-13 on 2006-05-01.
The following dates were fixed:
- latest date by which the EN has to be implemented
at national level by publication of an identical
national standard or by endorsement (dop) 2007-05-01
- latest date by which the national standards conflicting
with the EN have to be withdrawn (dow) 2009-05-01
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and covers essential requirements of
EC Directive 93/42/EEC. See Annex ZZ.
This European Standard partly replaces EN 740:1998, Anaesthetic workstations and their modules -
Particular requirements.
Other European Standards relating to anaesthetic workstations and their components prepared or in
preparation by CEN/TC215 which, when all published will together with EN 60601-2-13:2006 replace
EN 740:1998 in total, are:
– prEN ISO/DIS 8835-2:2005, Inhalational anaesthesia systems – Part 2: Anaesthetic breathing
systems for adults
– prEN ISO/DIS 8835-3.2:2005, Inhalational anaesthesia systems – Part 3: Transfer and receiving
systems of active anaesthetic gas scavenging systems
– EN ISO 8835-4:2004, Inhalational anaesthesia systems – Part 4: Anaesthetic vapour delivery devices
– EN ISO 8835-5:2004, Inhalational anaesthesia systems – Part 5: Anaesthetic ventilators
Attention is also drawn to ISO/TS 18835:2004, Inhalational anaesthesia systems — Draw-over vaporizers
and associated equipment.
In this standard, the following print types are used:
– requirements, compliance with which can be tested, and definitions: roman type;
– explanations, advice, notes, general statements, exceptions and references: small roman type;
– test specifications: italic type;
– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR OF THIS PARTICULAR STANDARD: SMALL
CAPITALS.
Annexes ZA and ZZ have been added by CENELEC.
__________
Endorsement notice
The text of the International Standard IEC 60601-2-13:2003 was approved by CENELEC as a European
Standard without any modification.
__________

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- 3 - EN 60601-2-13:2006
Annex ZA
(normative)

Normative references to international publications
with their corresponding European publications

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.

NOTE  When an international publication has been modified by common modifications, indicated by (mod), the relevant EN/HD
applies.


Publication Year Title EN/HD Year

IEC 60079-4 1975 Electrical apparatus for explosive gas - -
atmospheres
Part 4: Method of test for ignition temperature


IEC 60079-11 1999 Electrical apparatus for explosive gas -
-
atmospheres
Part 11: Intrinsic safety "i"


ISO 32 1977 Gas cylinders for medical use - Marking for - -
identification of content


ISO 407 1991 Small medical gas cylinders - Pin-index yoke-- -
type valve connections


ISO 3746 1995 Acoustics - Determination of sound power - -
levels of noise sources using sound pressure
Survey method using an enveloping
measurement surface over a reflecting plane


ISO 4135 2001 Anaesthetic and respiratory equipment - - -
Vocabulary


ISO 5145 1990 Cylinder valve outlets for gases and gas - -
mixtures - Selection and dimensioning


ISO 5356-1 1996 Anaesthetic and respiratory equipment - - -
Conical connectors
Part 1: Cones and sockets


ISO 5356-2 1987 Anaesthetic and respiratory equipment - - -
Conical connectors
Part 2: Screw-threaded weight-bearing
connectors


ISO 5359 2000 Low-pressure hose assemblies for use with - -
medical gas systems


ISO 5362 2000 Anaesthetic reservoir bags - -


ISO 7396-1 2002 Medical gas pipeline systems - -
Part 1: Pipelines for compressed medical
gases and vacuum

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EN 60601-2-13:2006 - 4 -
Publication Year Title EN/HD Year
1)
ISO 7767 1997 Oxygen monitors for monitoring patient - -
breathing mixtures - Safety requirements


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 8835-4 2004 Inhalational anaesthesia systems - -
Part 4: Anaesthetic vapour delivery devices


ISO 8835-5 2004 Inhalational anaesthesia systems - -
Part 5: Anaesthetic ventilators


ISO 9170-1 1999 Terminal units for medical gas pipeline - -
systems
Part 1: Terminal units for use with
compressed medical gases and vacuum


2)
ISO 9703-1 1992 Anaesthesia and respiratory care alarm - -
signals
Part 1: Visual alarm signals


2)
ISO 9703-2 1994 Anaesthesia and respiratory care alarm - -
signals
Part 2: Auditory alarm signals


2)
ISO 9703-3 1998 Anaesthesia and respiratory care alarm - -
signals
Part 3: Guidance on application of alarms


1)
ISO 9918 1993 Capnometers for use with humans - - -
Requirements


3)
ISO 10524 1995 Pressure regulators and pressure regulators - -
with flow-metering devices for medical gas
systems


1)
ISO 11196 1995 Anaesthetic gas monitors - -


ISO 15223 2000 Medical devices - Symbols to be used with - -
medical device labels, labelling and
information to be supplied



1)
ISO 7767:1997, ISO 9918:1993 and ISO 11196:1995 are superseded by ISO 21647:2004, which is harmonized as
EN ISO 21647:2004, Medical electrical equipment -- Particular requirements for the basic safety and essential performance of
respiratory gas monitors.
2)
The ISO 9703 series is superseded by IEC 60601-1-8:2003, which is harmonized as EN 60601-1-8:2004.
3)
ISO 10524:1995 is superseded by ISO 10524-1:2006, which is harmonized as EN ISO 10524-1:2006, Pressure regulators for use
with medical gases -- Part 1: Pressure regulators and pressure regulators with flow-metering devices.

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- 5 - EN 60601-2-13:2006
Annex ZZ
(informative)

Coverage of Essential Requirements of EC Directives
This European Standard has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all
relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential
requirements of the Directive concerned.
WARNING: Other requirements and other EC Directives may be applicable to the products falling within
the scope of this standard.
___________

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INTERNATIONAL IEC
STANDARD
60601-2-13
Third edition
2003-05
Medical electrical equipment –
Part 2-13:
Particular requirements for the safety and
essential performance of anaesthetic systems
Appareils électromédicaux –
Partie 2-13:
Règles particulières de sécurité et
performance essentielle pour les systèmes d’anesthésie
 IEC 2003
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any
means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher.
IEC Copyright Office Case postale 56 CH-1211 Genève 20 Switzerland
• • •
PRICE CODE
X
For price, see current catalogue

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– 2 – 60601-2-13  IEC:2003(E)
CONTENTS
FOREWORD . 4
INTRODUCTION . 6
SECTION ONE – GENERAL
1 Scope and object . 7
2 Terminology and definitions .10
3 General requirements .12
4 General requirements for tests.12
6 Identification, marking and documents .12
SECTION TWO – ENVIRONMENTAL CONDITIONS
10 Environmental conditions .16
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE
ANAESTHETIC MIXTURES
SECTION SEVEN – PROTECTION AGAINST EXCESSIVE TEMPERATURES AND
OTHER SAFETY HAZARDS
*43 Fire prevention .18
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization
and disinfection .18
49 Interruption of the POWER SUPPLY .19
SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
51 Protection against hazardous output .19
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS
ENVIRONMENTAL TESTS
52 Abnormal opertion and fault conditions .23
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
54 General .24
56 Components and general assembly .24
57 MAINS PARTS, components and layout.24

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60601-2-13  IEC:2003(E) – 3 –
SECTION 101 – ADDITIONAL CLAUSES SPECIFIC TO ANAESTHETIC GAS
DELIVERY SYSTEMS
101 Medical gas supply.25
102 Medical gas pipeline inlet connections .25
103 Medical gas supply pressure monitoring.26
104 Medical gas supply PRESSURE REGULATORs.26
105 Anaesthetic gas delivery system piping .26
106 Gas flow metering .27
107 Gas mixer .28
108 Oxygen flush.29
109 Fresh gas outlet .29
110 Checklist.29
Annex AA (informative) Guidance and rationale for particular clauses and subclauses
in this particular standard .30
Annex BB (informative) MONITORING DEVICES, ALARM SYSTEM(S) and PROTECTION DEVICES.34
Annex CC (informative) Separate devices of an ANAESTHETIC SYSTEM .35
Annex DD (normative) Test for flammability of anaesthetic agent .37
Annex EE (informative) Clauses of this International Standard addressing
the essential requirements or other provisions of EU directives .38
Bibliography .43
Index of defined terms .44
Figure 101 – Profile of oxygen flow control knob for applications other than anaesthetic
vapour delivery device flow control (See 106.3) .28
Table 101 – Test conditions for expiratory volume tests .21
Table 102 – Force of axial pulls .25
Table BB.1 – Summary of the relationship of MONITORING DEVICES, ALARM SYSTEM(S)
and PROTECTION DEVICES with regard to delivery devices.34
Table CC.1 – Applicable requirement clauses for separate devices of
an ANAESTHETIC SYSTEM .35
Table EE.1 – Correspondence between this International Standard and EEC Directive
93/42/EEC . 38

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– 4 – 60601-2-13  IEC:2003(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-13: Particular requirements for the safety
and essential performance of anaesthetic systems
FOREWORD
1) The IEC (International Electrotechnical Commission) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of the IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, the IEC publishes International Standards. Their preparation is
entrusted to technical committees; any IEC National Committee interested in the subject dealt with may
participate in this preparatory work. International, governmental and non-governmental organizations liaising
with the IEC also participate in this preparation. The IEC collaborates closely with the International
Organization for Standardization (ISO) in accordance with conditions determined by agreement between the
two organizations.
2) The formal decisions or agreements of the IEC on technical matters express, as nearly as possible, an
international consensus of opinion on the relevant subjects since each technical committee has representation
from all interested National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, technical specifications, technical reports or guides and they are accepted by the National
Committees in that sense.
4) In order to promote international unification, IEC National Committees undertake to apply IEC International
Standards transparently to the maximum extent possible in their national and regional standards. Any
divergence between the IEC Standard and the corresponding national or regional standard shall be clearly
indicated in the latter.
5) The IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with one of its standards.
6) Attention is drawn to the possibility that some of the elements of this International Standard may be the subject
of patent rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-13 has been developed by a Joint Working Group
consisting of IEC/SC 62D, Electromedical equipment, of IEC technical committee 62:
Electrical equipment in medical practice, and ISO TC 121/SC 1, Breathing attachments and
anaesthetic machines.
It is published as double logo standard.
This third edition cancels and replaces the second edition published in 1998. This edition
constitutes a technical revision.
The text of this Particular Standard is based on the following documents:
FDIS Report on voting
62D/475/FDIS 62D/476/RVD
Full information on the voting for the approval of this Particular Standard can be found in the
report on voting indicated in the above table. In ISO, the standard has been approved by 13
P-members out of 13 having cast a vote.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this Particular Standard, the following print types are used:
− requirements, compliance with which can be tested and definitions: roman type;
− explanations, advice, notes, general statements, exceptions and references: smaller type;

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60601-2-13  IEC:2003(E) – 5 –
− test specifications: italic type;
− TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD OR OF THIS PARTICULAR STANDARD:
SMALL CAPITALS.
The committee has decided that the contents of this publication will remain unchanged until
2007. At this date, the publication will be
• reconfirmed;
• withdrawn;
• replaced by a revised edition, or
• amended.

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– 6 – 60601-2-13  IEC:2003(E)
INTRODUCTION
In response to requests for harmonization between the current European and International
standards for anaesthetic workstations this standard has been developed by the
IEC/ISO Joint Working Group to specify requirements for ANAESTHETIC SYSTEMS supplied
complete, as well as requirements for individual devices which are intended to be part of an
ANAESTHETIC SYSTEM. It applies in conjunction with IEC 60601-1:1988 (Including all
amendments) hereafter referred to as the General Standard. As stated in 1.3 of
IEC 60601-1-1988, the requirements in this standard take priority over those of the General
Standard.
This standard has been structured to allow USERS to configure an ANAESTHETIC SYSTEM in
conformance with professional guidelines and to meet the needs of their clinical practice.
In order to achieve this aim, the standard identifies particular requirements pertinent to
specific devices, and to their associated MONITORING DEVICE(S), ALARM SYSTEM(s) and
PROTECTION DEVICE(S), and defines the interfaces. This standard also specifies requirements
for optional devices, together with their respective MONITORING DEVICE(S), ALARM SYSTEM(S)
and PROTECTION DEVICE(S).
The indicated requirements are followed by specifications for the relevant tests. An asterisk
(*) denotes clauses for which there is a rationale comment in Annex AA. It is considered that
knowledge of the reasons for these requirements will facilitate the proper application of the
standard and be of use in any revision that may be necessitated by changes in clinical
practice or as a result of developments in technology.
NOTE The decimal separator for all numeric values is "," (comma).
The following graphic representation of the structure of this standard is being provided for
informational purposes only.
General requirements
IEC 60601-2-13
Monitoring, alarm
Mandatory
ANAESTHETIC gas
and protection
delivery device
devices *)
ISO 8835-2
ANAESTHETIC
breathing system
Monitoring, alarm
ISO/DIS 8835-3
AGSS and protection
Anaesthetic
devices *)
system
Monitoring, alarm
Anaesthetic vapour
ISO/DIS 8835-4
and protection
delivery device
devices *)
Optional
devices
Monitoring, alarm
Anaesthetic
and protection
ISO/DIS 8835-5
ventilator
devices *)
Monitoring, alarm
Other devices(s) ISO/DIS 8835-X
and protection
devices *)

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60601-2-13  IEC:2003(E) – 7 –
MEDICAL ELECTRICAL EQUIPMENT–
Part 2-13: Particular requirements for the safety
and essential performance of anaesthetic systems
SECTION ONE – GENERAL
The clauses and subclauses of this section of the General Standard apply except as follows:
1 Scope and object
This clause of the General Standard applies except as follows:
1.1 Scope
Addition
This Particular Standard specifies safety and essential performance requirements for an
ANAESTHETIC SYSTEM (as defined in 2.101.7) as well as individual devices designed for use in
an ANAESTHETIC SYSTEM.
This Particular Standard does not apply to:
– ANAESTHETIC SYSTEM(S) intended for use with flammable anaesthetic agents, as
determined by Annex DD,
– portable ANAESTHETIC SYSTEM(S) for use in remote sites, open fields for rescue operations
or in disaster areas,
– dental analgesia apparatus.
1.2 Object
Replacement:
The object of this Particular Standard is to specify particular safety and essential performance
requirements for individual devices designed for use in an ANAESTHETIC SYSTEM as well as
specific requirements for the ANAESTHETIC GAS DELIVERY SYSTEM. This standard specifies
requirements and defines interfaces for:
– individual devices designed for use in an ANAESTHETIC SYSTEM(S), and
– integrated ANAESTHETIC SYSTEMS.
1.3 Particular Standards
This Particular Standard amends and supplements a set of IEC publications consisting of
IEC 60601-1:1988, Medical electrical equipment – Part 1: General requirements for safety,
its amendment 1 (1991) and amendment 2 (1995), hereinafter referred to as the “General
Standard”.
The General Standard takes into account IEC 60601-1-1:2000, Medical electrical equipment –
Part 1-1: General requirements for safety – Collateral standard: Safety requirements for
medical electrical systems and IEC 60601-1-2 2001, Medical electrical equipment – Part 1-2:
General requirements for safety – Collateral standard: Electromagnetic compatibility –
Requirements and tests.

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– 8 – 60601-2-13  IEC:2003(E)
The numbering of sections, clauses and subclauses of this Particular Standard corresponds
with that of the General Standard. The changes to the text of the General Standard are
specified by the use of the following words:
“Replacement” means that the clause or subclause of the General Standard is replaced
completely by the text of this Particular Standard.
“Addition” means that the text of this Particular Standard is additional to the requirements of
the General Standard.
“Amendment” means that the clause or subclause of the General Standard is amended as
indicated by the text of this Particular Standard.
Subclauses or figures which are additional to those of the General Standard are numbered
starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb),
etc.
The term "this standard" covers this Particular Standard, used together with the General
Standard and the Collateral Standards.
Where there is no corresponding section, clause or subclause in this Particular Standard, the
section, clause or subclause of the General Standard, although possibly not relevant, applies
without modification.
Where it is intended that any part of the General Standard, although possibly relevant, is not
to be applied, a statement to that effect is given in this Particular Standard.
The requirements of this Particular Standard replacing or modifying requirements of the
General Standard or a Collateral Standard take precedence over the corresponding general
requirement(s).
1.3.101 Related International Standards
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.
IEC 60079-4:1975, Electrical apparatus for explosive gas atmospheres – Part 4: Method of
test for ignition temperature
IEC 60079-11:1999, Electrical apparatus for explosive gas atmospheres – Part 11: Intrinsic
safety"
ISO 32:1977, Gas cylinders for medical use – Marking for identification of content
ISO 407:1991, Small medical gas cylinders – Pin-index yoke-type valve connections
ISO 3746:1995, Acoustics – Determination of sound power levels of noise sources using
sound pressure – Survey method using an enveloping measurement surface over a reflecting
plane
ISO 4135:2001, Anaesthetic and respiratory equipment – Vocabulary
ISO 5145:1990, Cylinder valve outlets for gases and gas mixtures – Selection and
dimensioning

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60601-2-13  IEC:2003(E) – 9 –
ISO 5356-1:1996, Anaesthetic and respiratory equipment – Conical connectors – Part 1:
Cones and sockets
ISO 5356-2:1987, Anaesthetic and respiratory equipment – Conical connectors – Part 2:
Screw-threaded, weight-bearing connectors
ISO 5359:2000, Low-pressure hose assemblies for use with medical gases
ISO 5362:2000, Anaesthetic reservoir bags
ISO 7396-1:2002, Medical gas pipeline systems – Part 1: Pipelines for compressed medical
gases and vacuum
ISO 7767:1997, Oxygen monitors for monitoring patient breathing mixtures – Safety
requirements
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 8835-4, Inhalational anaesthesia systems – Part 4: Anaesthetic vapour delivery
)
1
devices
ISO 8835-5, Inhalational anaesthesia systems – Part 5: Requirements for anaesthetic
)
2
ventilators
ISO 9170-1:1999, Terminal units for medical gas pipeline systems – Part 1: Terminal units for
use with compressed medical gases and vacuum
ISO 9703-1:1992, Anaesthesia and respiratory care alarm signals – Part 1: Visual alarm
signals
ISO 9703-2:1994, Anaesthesia and respiratory care alarm signals – Part 2: Auditory alarm
signals
ISO 9703-3, Anaesthesia and respiratory care alarm signals – Part 3: Guidance on application
of alarms
ISO 9918:1993, Capnometers for use with humans – Requirements
ISO 10524:1995, Pressure regulators and pressure regulators with flow-metering devices for
medical gas systems
ISO 11196:1996, Anaesthetic gas monitors
ISO 15223:2000, Medical devices – Symbols to be used with medical device labels, labelling
and information to be supplied
___________
1)
To be pub
...