IEC 60601-2-13:1998
(Main)Medical electrical equipment — Part 2-13: Particular requirements for the safety of anaesthetic workstations
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
General Information
Relations
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
IEC 60601-2-13:1998(E)
---------------------- Page: 1 ----------------------
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.
---------------------- Page: 2 ----------------------
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: +41 22 919 0300 e-mail: inmail@iec.ch IEC web site http: //www.iec.ch
PRICE CODE
U
For price, see current catalogue
---------------------- Page: 3 ----------------------
– 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
---------------------- Page: 4 ----------------------
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
---------------------- Page: 5 ----------------------
– 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.
---------------------- Page: 6 ----------------------
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
---------------------- Page: 7 ----------------------
– 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.
---------------------- Page: 8 ----------------------
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 ANAESTHETIC WORKSTATIONs and
individual devices be commercially available to allow users to configure an ANAESTHETIC
WORKSTATION to meet the needs of their clinical practice in conformance with their national
regulations. To this end the standard has been structured in such a way as to clearly define
interfaces and to identify particular requirements pertinent to specific devices currently available.
Attention is drawn to recommendations for patient monitoring during anaesthesia made by
many national clinical and regulatory bodies. These recommendations include, but are not
limited to, monitoring of the patient's electrocardiogram, blood pressure, body temperature and
pulse oximetry.
NOTE – Although this Particular Standard does not mandate the use of the MONITORING DEVICEs referred to in the
paragraph above, manufacturers of ANAESTHETIC WORKSTATIONs are encouraged to make provision for such
monitors so that the user can more easily assimilate their data output and so that the alarm function of the various
monitors can be integrated.
To facilitate data transfer capability between different MONITORING DEVICEs, a “bus” or data
transfer system may be used.
ANAESTHETIC WORKSTATIONs and/or their components intended for use with flammable
anaesthetic agents are not covered by this standard, nor are dental analgesia apparatus.
1.3 Particular Standards
Addition:
This Particular Standard amends and supplements a set of IEC publications, hereinafter
referred to as “General Standard”, consisting of
IEC 60601-1: 1988, Medical electrical equipment – Part 1: General requirements for safety
Amendment 1, amendment 2,
IEC 60601-1-1: 1992, Medical electrical equipment – Part 1: General requirements for safety,
1. Collateral Standard: Safety requirements for medical electrical systems
Amendment 1
IEC 60601-1-2: 1993, Medical electrical equipment – Part 1: General requirements for safety,
2. Collateral Standard: Electromagnetic compatibility – Requirements and tests
---------------------- Page: 9 ----------------------
– 8 – 60601-2-13 © IEC:1998(E)
For brevity, IEC 60601-1 is referred to in this Particular Standard either as the “General
Standard” or as the “General Requirement(s)”, and IEC 60601-1-1 and IEC 60601-1-2 as the
“Collateral Standards”.
The term “this standard” covers this Particular Standard, used together with the General
Standard and Collateral Standards.
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.
Clauses, subclauses, figures and tables 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.
Clauses and subclauses to which there is a rationale are marked with an asterisk*. These
rationales can be found in an informative annex BB. Annex BB is not part of this Particular
Standard and only gives additional information; it can never be the subject of testing.
Where there is no corresponding section, clause or subclause in this Particular Standard, the
section, clause or subclause of the General Standard applies without modification.
Where it is intended that any part of the General Standard or Collateral Standards, although
possibly relevant, is not to be applied, a statement to that effect is given in this Particular Standard.
A requirement of this Particular Standard replacing or modifying requirements of the General
Standard or Collateral Standards takes precedence over the corresponding General
Requirement(s).
2 Terminology and definitions
This clause of the General Standard applies together with the definitions given in ISO 4135,
ISO 9703-1, ISO 9703-2 and the following additional definitions:
2.101 ALARM DEVICE
Device which provides a visual and/or auditory signal when an alarm condition is present.
2.102 ANAESTHETIC VAPOUR DELIVERY DEVICE (concentration calibrated vaporizer)
Device which provides the vapour of an anaesthetic agent in a controllable concentration.
2.103 ANAESTHETIC WORKSTATION
PROTECTION DEVICE
Assembly of devices and their associated monitoring, alarm, and s which
control the flow and composition of the fresh gas delivered during anaesthesia.
ANAESTHETIC WORKSTATION ANAESTHETIC VAPOUR DELIVERY DEVICE
NOTE – The may include an (s), an anaesthesia
ventilator, an anaesthesia breathing system, and an anaesthetic gas scavenging system in whole or in part.
---------------------- Page: 10 ----------------------
60601-2-13 © IEC:1998(E) – 9 –
2.104 APPLIED PART
FRESH GAS OUTLET, if provided, and all the other parts of the ANAESTHETIC WORKSTATION
intended to be connected with the patient or with the anaesthesia breathing system.
2.105 BIAS
Constant or systematic error which manifests itself as a persistent deviation of the method
average from the accepted reference value.
2.106 CONTINUOUS DISPLAY
Display where the value is updated continuously or at a clinically appropriate frequency.
2.107 DEFAULT CONDITIONS; DEFAULT SETTINGS
Those operating parameters within the equipment, which are pre-set at the factory or by the
operator and which, without further intervention, are restored when the equipment is turned on.
2.108 DISABLE
To prevent the response of a functioning device.
2.109 FRESH GAS OUTLET; COMMON GAS OUTLET
That port through which the dispensed mixture of anaesthetic gases and vapour is delivered.
2.110 GAS FLOWMETER
Device which indicates the volume of a specific gas or gas mixture passing in a unit of time.
2.111 GAS FLOW CONTROL SYSTEM
Device or assembly that controls the flow of gas(es) or gas mixtures.
2.112 GAS MIXER
Device which receives separate supplies of oxygen and other medical gas(es) and which
delivers the mixed gases in concentrations adjustable by the operator.
2.113 INTERCHANGEABLE ANAESTHETIC VAPOUR DELIVERY DEVICE
Operator-detachable ANAESTHETIC VAPOUR DELIVERY DEVICE designed to be used with specified
equipment from different manufacturers.
2.114 MACHINE GAS PIPING
All pipework, including unions, from unidirectional valves in the pipeline inlets and from the
outlets of the PRESSURE REGULATORs to the flow control system, as well as the piping
connecting the flow control system and the piping connecting the ANAESTHETIC VAPOUR
DELIVERY DEVICE to the FRESH GAS OUTLET. It includes piping leading to and from pneumatic
alarm systems, gauges, oxygen flush and gas power outlets.
---------------------- Page: 11 ----------------------
– 10 – 60601-2-13 © IEC:1998(E)
2.115 MONITORING DEVICE
Device which continuously or repeatedly measures and indicates the value of a variable to the
operator.
2.116 NON-INTERCHANGEABLE ANAESTHETIC VAPOUR DELIVERY DEVICE
ANAESTHETIC VAPOUR DELIVERY DEVICE designed to be used only with equipment specified by
the manufacturer.
NOTE – These devices may or may not be operator-detachable.
2.117 POWER SUPPLY
Any source of energy, other than that generated directly by the human body or by gravity, that
makes the device function.
2.118 PRECISION
That quality which characterizes the ability of a device to give for the same value of the quantity
measured, indications which agree amongst themselves, not taking into consideration the
systematic errors associated with variations of the indications.
2.119 PRESSURE REGULATOR
Gas pressure reducing and controlling device designed to provide a constant outlet pressure
over a specified range of inlet pressures.
2.120 PROTECTION DEVICE
Device which, without intervention of the operator, protects the patient from hazardous output
due to incorrect delivery of energy or substances.
2.121 SMART ALARM SYSTEM
Alarm system which, based on monitored information from clinical or technical variables, is
designed to make logic decisions and, therefore, without operator intervention, to have the
ability, for example, to allocate more than one priority for the same alarm condition, or to
suppress, temporarily, the activation of an alarm.
2.122 SILENCING
To suppress, temporarily, the auditory component of an alarm.
3 General requirements
This clause of the General Standard applies except as follows:
3.6
Additional items:
aa) Short and open circuits of components or wiring which can increase temperatures (see
section seven).
*bb) An oxidant leak which is not detected by, for example, alarm or periodic inspection, shall
be considered a normal condition and not a single-fault condition.
---------------------- Page: 12 ----------------------
60601-2-13 © IEC:1998(E) – 11 –
6 Identification, marking and documents
This clause of the General Standard applies except as follows:
6.1 Marking on the outside of equipment or equipment parts:
*j) Power input
Addition:
The input marking required in 6.1 j) of the General Standard shall be given in amperes for the
ANAESTHETIC WORKSTATION, and for the sum of the current ratings for the ANAESTHETIC
WORKSTATION and the auxiliary mains socket outlets.
*k) Mains power output
Addition:
The requirement on marking of auxiliary mains socket outlets of 6.1 k) in the General Standard
shall apply to each auxiliary mains socket outlet and shall be given in amperes.
If auxiliary mains socket outlets can accept a mains plug, the auxiliary mains socket outlet shall
be marked with symbol 14 of table D.1 of the General Standard.
Additional items:
aa) Each operator – accessible gas inlet and outlet shall be durably marked with either the gas
name or chemical symbol in accordance with ISO 5359. This marking shall be clearly
legible, and if colour coding is used, it shall be in accordance with ISO 32.
bb) The FRESH GAS OUTLET, if operator accessible, shall be durably marked. This marking shall
be clearly legible.
cc) The ANAESTHETIC WORKSTATION and/or its components and/or packaging shall include the
following information as applicable:
– the symbol "STERILE" together with the method of sterilization;
– the batch code, preceded by the symbol "LOT", or the serial number;
– an indication of the date, expressed as the year and month, by which the device can be
used safely;
– an indication that the device is for single use;
NOTE – Symbol No. 1051 given in ISO 7000 may be used.
– any special storage and/or handling conditions;
– any warning or precautions to be taken;
– for active medical devices, the year of manufacture except for single use devices and
those covered by the date of expiry;
– the recommended method(s) of cleaning, disinfection, and sterilization;
– the device packaging and/or labelling shall differentiate between the same or similar
products placed on the market both sterile and non-sterile by the same manufacturer;
– the name or trade name and address of the manufacturer and, if applicable, the
distributor/supplier;
– if the intended purpose of the device is not obvious to the operator, the component or its
packaging shall be provided with details necessary to identify the device and the
contents of the packaging;
– any special operating instructions.
---------------------- Page: 13 ----------------------
– 12 – 60601-2-13 © IEC:1998(E)
dd) The ANAESTHETIC WORKSTATION and/or its components shall be marked with the rated
supply pressure(s) to which the equipment may be connected.
ee) All operator-detachable components or devices, which can be misconnected, and which
are flow direction-sensitive shall be durably marked with a clearly legible arrow indicating
the correct direction of gas flow.
ff) Where appropriate, detachable components shall be identified in terms of batches.
gg) Controls for gas flows or anaesthetic vapour output shall be durably marked with a clearly
legible indication to inform the operator which action(s) is/are required to increase/
decrease the gas flow or vapour output.
6.3 Marking of controls and instruments
Additional items:
aa) All cylinder and pipeline pressure gauges or indicators shall be graduated and clearly
marked or displayed in units of kPa × 100 when the anaesthetic workstation is in use. The
markings and graduations shall be clearly identified with the gauges or indicators with
which they are associated.
NOTE – Additional marking for example bar may be used.
Each gas-specific pressure gauge or indicator shall be identified by clear and durable
marking using the gas name or the chemical symbol in accordance with ISO 5359. If
colour coding is used it shall be in accordance with ISO 32.
Pressure gauges or indicators for measuring pressure in the anaesthesia breathing system
shall be graduated in units of pascals and/or cm H O.
2
bb) Each flow adjustment control of a single gas supply and/or its surroundings, shall be
identified and durably marked with the gas name or the chemical symbol in accordance
with ISO 5359. This marking shall be clearly legible, and if colour coding is used, it shall
be in accordance with ISO 32.
The concentration adjustment control of a GAS MIXER and/or its surroundings shall be
identified and durably marked with the gas name(s) or the chemical symbol(s) in
accordance with ISO 5359. This marking shall be clearly legible, and if color coding is
used, it shall be in accordance with ISO 32. The scale including the minimum and
maximum concentration marks of the gas mixture control of a GAS MIXER shall be marked
to indicate the concentration of oxygen (% V/V) in the delivered gas.
If applicable the point of reference for reading the flow indication shall be identified.
cc) For ANAESTHETIC VAPOUR DELIVERY DEVICE(s)
Either the maximum and minimum filling levels shall be marked on the liquid level
indicator, or the actual usable volume shall be clearly displayed.
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" or "D"
– Enflurane – "ENF" or "E"
– Halothane – "HAL" or "H"
– Isoflurane – "ISO" or "I"
– Methoxyflurane – "MET" or "M"
– Sevoflurane – "SEV" or "S"
---------------------- Page: 14 ----------------------
60601-2-13 © IEC:1998(E) – 13 –
If colour coding is used, it shall be in accordance with column 2 (colour) of table CC.1.
The units in which the control of the ANAESTHETIC VAPOUR DELIVERY DEVICE is graduated
shall be indicated.
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" is not provided.
dd) The oxygen flush control shall be durably marked with one of the following:
– “OXYGEN FLUSH”
–“O FLUSH”
2
–“O +”
2
This marking shall be clearly legible, and if colour coding is used, it shall be in accordance with
ISO 32.
6.8
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.