IEC 60601-2-13:1998

Medical electrical equipment - Part 2-13: Particular requirements for the safety of anaesthetic workstations

Specifies particular requirements for the safety of anaesthetic workstations for inhalational anaesthesia intended for human use supplied complete, as well as particular requirements for individual devices which are intended to be part of an anaesthetic workstation.

General Information

• Status: Published
• Publication Date: 28-May-1998
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 27-May-2003

Relations

• Revised: IEC 60601-2-13:2003 - Medical electrical equipment - Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL
IEC
STANDARD
60601-2-13
[ISO 8835-1]
Second edition
1998-05
Medical electrical equipment –
Part 2-13:
Particular requirements for the safety
of anaesthetic workstations
Appareils électromédicaux –
Partie 2-13:
Règles particulières de sécurité
pour les appareils d’anesthésie

Reference number
Numbering
As from 1 January 1997 all IEC publications are issued with a designation in the

60000 series.
Consolidated publications
Consolidated versions of some IEC publications including amendments are
available. For example, 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.

Validity of this publication
The technical content of IEC publications is kept under constant review by the IEC,
thus ensuring that the content reflects current technology.
Information relating to the date of the reconfirmation of the publication is available
in the IEC catalogue.
Information on the subjects under consideration and work in progress undertaken by
the technical committee which has prepared this publication, as well as the list of
publications issued, is to be found at the following IEC sources:
• IEC web site*
• Catalogue of IEC publications
Published yearly with regular updates
(On-line catalogue)*
• IEC Bulletin
Available both at the IEC web site* and as a printed periodical
Terminology, graphical and letter symbols
For general terminology, readers are referred to IEC 60050: International
Electrotechnical Vocabulary (IEV).
For graphical symbols, and letter symbols and signs approved by the IEC for
general use, readers are referred to publications IEC 60027: Letter symbols to be
used in electrical technology, IEC 60417: Graphical symbols for use on equipment.
Index, survey and compilation of the single sheets and IEC 60617: Graphical symbols
for diagrams.
* See web site address on title page.

INTERNATIONAL
IEC
STANDARD
60601-2-13
[ISO 8835-1]
Second edition
1998-05
Medical electrical equipment –
Part 2-13:
Particular requirements for the safety
of anaesthetic workstations
Appareils électromédicaux –
Partie 2-13:
Règles particulières de sécurité
pour les appareils d’anesthésie

 IEC 1998  Copyright - all rights reserved
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.
International Electrotechnical Commission 3, rue de Varembé Geneva, Switzerland
Telefax: [phone] e-mail: [e-mail] IEC web site http: //www.iec.ch
PRICE CODE
XA
For price, see current catalogue

– 2 – 60601-2-13 © IEC:1998(E)

CONTENTS
Page
FOREWORD . 4

INTRODUCTION . 6

SECTION ONE – GENERAL
Clause
1 Scope and object. 7
2 Terminology and definitions . 8
3 General requirements . 10
6 Identification, marking and documents . 11
SECTION TWO – ENVIRONMENTAL CONDITIONS
10 Environmental conditions . 16
SECTION THREE – PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
19 Continuous leakage currents and patient auxiliary currents. 16
SECTION FOUR – PROTECTION AGAINST MECHANICAL HAZARDS
SECTION FIVE – PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION
36 Electromagnetic compatibility. 17
SECTION SIX – PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES
37 Locations and basic requirements . 17
38 Marking, accompanying documents. 17
39 Common requirements for category AP and category APG equipment . 18
40 Requirements and tests for category AP equipment, parts and components thereof. 18
41 Requirements and tests for category APG equipment, parts and components thereof 18

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

60601-2-13 © IEC:1998(E) – 3 –

Page
SECTION TEN – CONSTRUCTIONAL REQUIREMENTS

Clause
54 General . 25
56 Components and general assembly . 25

57 Mains parts, components and layout . 25

101 Medical gas supply systems. 26

102 Medical gas pipeline inlet connections . 27

103 Medical gas supply pressure monitoring. 27
104 Medical gas supply PRESSURE REGULATORs . 27
105 MACHINE GAS PIPING . 28
106 Gas flow metering . 28
107 GAS MIXER . 29
108 ANAESTHETIC VAPOUR DELIVERY DEVICE . 30
109 Oxygen flush . 36
110 FRESH GAS OUTLET . 36
111 Checklist . 37
SECTION ELEVEN – ANAESTHETIC VENTILATOR, ANAESTHESIA BREATHING
SYSTEM AND ANAESTHETIC GAS SCAVENGING SYSTEM
112 Anaesthetic ventilator . 37
113 Anaesthesia breathing systems. 37
114 Anaesthetic gas scavenging systems . 37
115 Suction equipment. 37
Tables
101 Test conditions for expiratory volume tests . 22
102 Force of axial pulls . 26
103 Settings to be used for testing accuracy of delivered concentration . 32
CC.1 Recommended colours for colour coding of anaesthetic vapour delivery devices . 46
EE.1 Summary of alarm monitoring and PROTECTION DEVICEs. 48
Figures
101 Profile of oxygen flow control knob for applications other than ANAESTHETIC VAPOUR
DELIVERY DEVICE flow control. 29
102 ANAESTHETIC WORKSTATION – COMMON GAS OUTLET according to

Swedish standard SS 87 524 30 . 38
Annexes
L References – Publications mentioned in this standard. 39
AA Bibliography . 41
BB Rationale. 42
CC Recommended colours for ANAESTHETIC VAPOUR DELIVERY DEVICEs. 46
DD Test for flammability of anaesthetic agents . 47
EE Summary of ALARM, MONITORING, and PROTECTION DEVICES. 48
FF Requirements pertaining to delivered vapour concentration accuracy
under stated conditions. 49
GG Applicable requirement clauses for separate devices of an anaesthetic workstation. 50

– 4 – 60601-2-13 © IEC:1998(E)

INTERNATIONAL ELECTROTECHNICAL COMMISSION

___________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-13: Particular requirements for the safety of

ANAESTHETIC WORKSTATIONS
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 cooperation 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 the 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 the interested National Committees.
3) The documents produced have the form of recommendations for international use and are published in the form
of standards, 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 elements of this International Standard may be subject to patent
rights. The IEC shall not be held responsible for identifying any or all such patent rights.
International Standard IEC 60601-2-13/Ed. 2 was developed by the Joint Working Group of
ISO/TC 121/SC 1, Breathing attachments and anaesthetic machines, and IEC/SC 62D,
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition of IEC 60601-2-13 cancels and replaces the first edition published in 1989.
This second edition constitutes a technical revision.

The text of this Particular Standard is based on the following documents:
FDIS Report on voting
62D/249/FDIS 62D/282/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.
Annex DD forms an integral part of this standard.
Annexes AA, BB, CC, EE, FF and GG are for information only.
A bilingual version of this standard may be issued at a later date.

60601-2-13 © IEC:1998(E) – 5 –

In this Particular Standard, the following print types are used:

– requirements, compliance with which can be tested, and definitions: roman type;

– notes, explanations, advice, introductions, general statements and references: smaller roman type;

– test specifications: italic type;

– TERMS DEFINED IN CLAUSE 2 OF THE GENERAL STANDARD IEC 60601-1 OR IN THIS PARTICULAR
STANDARD: SMALL CAPITALS
– 6 – 60601-2-13 © IEC:1998(E)

INTRODUCTION
This Particular Standard specifies particular requirements for ANAESTHETIC WORKSTATIONs for

inhalational anaesthesia intended for human use. It applies in conjunction with IEC 60601-1

(including the amendments). The relationship of this Particular Standard with IEC 60601-1 is
explained in 1.3.
All pressures are expressed as differences from ambient atmospheric pressure.

60601-2-13 © IEC:1998(E) – 7 –

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-13: Particular requirements for the safety of

ANAESTHETIC WORKSTATIONS
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:
Addition
1.2 This Particular Standard presents particular requirements for ANAESTHETIC WORKSTATIONs
for inhalational anaesthesia intended for human use supplied complete, as well as particular
requirements for individual devices which are intended to be part of an ANAESTHETIC
WORKSTATION
.
It is the intent of this Particular Standard that both complete ANAES
...