IEC 60601-2-13:2003
(Main)Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
Specifies 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 systems(s), and - integrated anaesthetic systems.
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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
Reference number
Publication numbering
As from 1 January 1997 all IEC publications are issued with a designation in the
60000 series. For example, IEC 34-1 is now referred to as IEC 60034-1.
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edition numbers 1.0, 1.1 and 1.2 refer, respectively, to the base publication, the
base publication incorporating amendment 1 and the base publication incorporating
amendments 1 and 2.
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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
– 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
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
– 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;
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.
– 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 o
...
IEC 60601-2-13
Edition 3.1 2009-08
INTERNATIONAL
STANDARD
Medical electrical equipment –
Part 2-13: Particular requirements for the safety and essential performance of
anaesthetic systems
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
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International Standards for all electrical, electronic and related technologies.
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IEC 60601-2-13
Edition 3.1 2009-08
INTERNATIONAL
STANDARD
Medical electrical equipment –
Part 2-13: Particular requirements for the safety and essential performance of
anaesthetic systems
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
PRICE CODE
CN
ICS 11.040.10 ISBN 978-2-88910-215-0
– 2 – 60601-2-13 © IEC:2003+A1:2006(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 .17
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 .19
49 Interruption of the POWER SUPPLY.19
SECTION EIGHT – ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDOUS OUTPUT
51 Protection against hazardous output.
SECTION NINE – ABNORMAL OPERATION AND FAULT CONDITIONS
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions .24
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS
54 General.24
56 Components and general assembly .24
57 MAINS PARTS, components and layout .25
60601-2-13 © IEC:2003+A1:2006(E) – 3 –
SECTION 101 – ADDITIONAL CLAUSES SPECIFIC TO ANAESTHETIC GAS
DELIVERY SYSTEMS
101 Medical gas supply .26
102 Medical gas pipeline inlet connections .26
103 Medical gas supply pressure monitoring .26
104 Medical gas supply PRESSURE REGULATORs .27
105 Anaesthetic gas delivery system piping .27
106 Gas flow metering .27
107 Gas mixer .29
108 Oxygen flush .29
109 Fresh gas outlet.30
110 Checklist.30
Annex AA (informative) Guidance and rationale for particular clauses and subclauses
in this particular standard .31
Annex BB (informative) MONITORING DEVICES, ALARM SYSTEM(S) and PROTECTION DEVICES .35
Annex CC (informative) Separate devices of an ANAESTHETIC SYSTEM .36
Annex DD (normative) Test for flammability of anaesthetic agent.38
Annex EE (informative) Clauses of this International Standard addressing
the essential requirements or other provisions of EU directives .39
Bibliography .44
Index of defined terms .45
Figure 101 – Profile of oxygen flow control knob for applications other than anaesthetic
vapour delivery device flow control (See 106.3) .29
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 .35
Table CC.1 – Applicable requirement clauses for separate devices of
an ANAESTHETIC SYSTEM .36
Table EE.1 – Correspondence between this International Standard and EEC Directive
93/42/EEC.39
– 4 – 60601-2-13 © IEC:2003+A1:2006(E)
INTERNATIONAL ELECTROTECHNICAL COMMISSION
___________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-13: Particular requirements for the safety
and essential performance of anaesthetic systems
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of 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, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). 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. 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 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 IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC provides no marking procedure to indicate its approval and cannot be rendered responsible for any
equipment declared to be in conformity with an IEC Publication.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. 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 consolidated version of IEC 60601-2-13 consists of the third edition (2003) [documents
62D/475/FDIS and 62D/476/RVD] and its amendment 1 (2006) [documents 62D/516/CDV and
62D/537A/RVC].
The technical content is therefore identical to the base edition and its amendment and has
been prepared for user convenience.
It bears the edition number 3.1.
60601-2-13 © IEC:2003+A1:2006(E) – 5 –
A vertical line in the margin shows where the base publication has been modified by
amendment 1.
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;
− 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 the base publication and its amendments will
remain unchanged until the maintenance result date indicated on the IEC web site under
"http://webstore.iec.ch" in the data related to the specific publication. At this date,
the publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
– 6 – 60601-2-13 © IEC:2003+A1:2006(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
...
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