ISO 11197:2004

INTERNATIONAL ISO
STANDARD 11197
Second edition
2004-12-15

Medical supply units
Gaines techniques à usage médical




Reference number
ISO 11197:2004(E)
©
ISO 2004

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ISO 11197:2004(E)
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ISO 11197:2004(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 11197 was prepared by the European Committee for Standardization (CEN) in collaboration with
Technical Committee ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 6, Medical gas
systems, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna
Agreement).
Throughout the text of this document, read “.this European Standard.” to mean “.this International
Standard.”.
This second edition cancels and replaces the first edition (ISO 11197:1996), which has been technically
revised.
Annex ZB provides a list of corresponding International and European Standards for which equivalents are not
given in the text.
For the purposes of this International Standard, the CEN annex regarding fulfilment of European Council
Directives has been removed.
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ISO 11197:2004(E)

Contents
 page
Foreword.vii
Introduction .viii
SECTION ONE - GENERAL .1
1 Scope .1
2 Normative references .1
3 Terms and definitions .2
4 General requirements and requirements for tests.2
5 Classification.3
6 Identification, marking and documents.3
7 Power input .7
SECTION TWO - ENVIRONMENTAL CONDITIONS .8
8 Basic safety categories.8
9 Removable protection means.8
10 Environmental conditions.8
11 Not Used .8
12 Not Used .8
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS.9
13 General.9
14 Requirements related to classification.9
15 Limitation of voltage and/or energy.9
16 Enclosures and protective covers .9
17 Separation .9
18 Protective earthing, functional earthing and potential equalization .9
19 Continuous leakage current and patient auxiliary currents.9
20 Dielectric strength .10
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS .11
21 Mechanical strength .11
22 Moving parts.11
23 Surfaces, corners and edges.11
24 Stability in normal use .11
25 Expelled parts .12
26 Vibration and noise.12
27 Pneumatic and hydraulic power.12
28 Suspended masses .12

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ISO 11197:2004(E)
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION.13
29 X-Radiation.13
30 Alpha, beta, gamma, neutron radiation and other particle radiation .13
31 Microwave radiation .13
32 Light radiation (including lasers).13
33 Infra-red radiation .13
34 Ultraviolet radiation.13
35 Acoustical energy (including ultrasonics).13
36 Electromagnetic compatibility .13
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC
MIXTURES .15
37 Locations and basic requirements .15
38 Marking and accompanying documents.15
39 Common requirements for Category AP and Category APG Equipment.15
40 Requirements and tests for Category AP Equipment, parts and components thereof .15
41 Requirements and tests for Category APG Equipment, parts and components thereof.15
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY
HAZARDS .16
42 Excessive temperatures.16
43 R Fire prevention .16
44 Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and
disinfection.16
45 Pressure vessels and parts subject to pressure.16
46 Human errors .17
47 Electrostatic charges .17
48 Material in applied parts in contact with the body of the patient .17
49 Interruption of the power supply .17
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS
OUTPUT .18
50 Accuracy of operating data .18
51 Protection against hazardous output.18
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS, ENVIRONMENTAL TESTS.19
52 Abnormal operation and fault conditions .19
53 Environmental tests .19
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS .19
54 General.19
55 Enclosures and covers .19
56 Components and general assembly.19
57 Mains parts, components and layout .19
58 Protective earthing - terminals and connections .20
59 Construction and layout .21
Annexes.33
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ISO 11197:2004(E)
Annex A A (normative) Special National Conditions .34

Annex B B (informative) Rationale.35
Annex ZB (Informative) Normative references to international publications with their relevant
European publications .37
Bibliography .38

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ISO 11197:2004(E)

Foreword

This document (EN ISO 11197:2004) has been prepared by CEN /TC 215, "Respiratory and anaesthetic
equipment", the secretariat of which is held by BSI, in collaboration with ISO/TC121/SC6 "Medical gas
systems".
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 June 2005, and conflicting national standards shall be withdrawn at
the latest by June 2005.
This document supersedes EN 793: 1997.
This European Standard 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 special national conditions for Clauses 6.1 k), 6.1 bb), 6.2 aa) and 57.1, see Annex AA.
For a list of International Standards identical to the European Standards referred to in this European Standard,
see informative Annex ZB.
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.
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ISO 11197:2004(E)

Introduction

This particular standard applies in conjunction with EN 60601-1 "Medical electrical equipment — Part 1:
General requirements for safety".
As stated in EN 60601-1 the requirements of this Particular Standard take priority over those of EN 60601-1.
As in EN 60601-1 the requirements are followed by the relevant tests. The structure of this particular standard
corresponds to that of EN 60601-1 and the sections, clauses and sub-clauses refer to those of EN 60601-1.
Clauses, subclauses, Tables and Figures additional to those in EN 60601-1 are numbered beginning at "101".
Additional annexes are lettered beginning at "AA" except for annexes "ZA" and "ZB".
Additional items in lettered lists are lettered beginning "aa)".
Annex BB contains rationale statements for some of the requirements of EN ISO 11197. It is included to
provide additional insight into the reasoning that led to the requirements and recommendations that have been
incorporated into EN ISO 11197. The clauses and subclauses marked with R after their number have
corresponding rationale contained in Annex BB. It is considered that knowledge of the reasons for the
requirements will not only facilitate the proper application of this standard, but will expedite any subsequent
revision.
In any health care facility it is strongly recommended that terminal units of only one type (i.e. with the same set
of specific dimensions) are used for each medical gas system, anaesthetic gas scavenging system and liquid
system.
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ISO 11197:2004(E)
SECTION ONE - GENERAL
1 Scope
Clause 1 of EN 60601-1:1990 applies with the following addition:
This document applies to medical supply units as defined in 3.5.
This particular document applies in conjunction with EN 60601-1.
The requirements of this particular document take priority over those of EN 60601-1.
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.
EN 737-1, Medical gas pipeline systems — Part 1: Terminal units for compressed medical gases and vacuum.
EN 737-2, Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems – Basic
requirements.
EN 737-3, Medical gas pipeline systems — Part 3: Pipelines for compressed medical gases and vacuum.
EN 737-4, Medical gas pipeline systems — Part 4: Terminal units for anaesthetic gas scavenging systems.
EN 739:1998, Low-pressure hose assemblies for use with medical gases.
EN ISO 3744, Acoustics — Determination of sound power levels of noise sources using sound pressure -
Engineering method in an essentially free field over a reflecting plane (ISO 3744:1994).
EN ISO 14971, Medical devices - Application of risk management to medical devices (ISO 14971:2000).
IEC 60079-4, Electrical apparatus for explosive gas atmospheres — Part 4: Method of test for ignition
temperature.
EN 60529, Degrees of protection provided by enclosures (IP code) (IEC 60529:1989).
EN 60598-1, Luminaires — Part 1: General requirements and tests (IEC 60598-1:1999, modified).
EN 60601-1:1990, Medical electrical equipment — Part 1: General requirements for safety (IEC 60601-
1:1988).
EN 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for safety; Collateral standard:
Electromagnetic compatibility; Requirements and tests (IEC 60601-1-2:2001).
EN 60669-1, Switches for household and similar fixed electrical installations — Part 1: General requirements
(IEC 60669-1:1998, modified).
EN 61386-1, Conduit systems for electrical installations – Part 1: General requirements (IEC 61386-
1:1996+A1:2000).

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ISO 11197:2004(E)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in EN 60601-1:1990 and the following
apply.
3.1
compartment
part of an enclosure with openings necessary for interconnection, control or ventilation
3.2
enclosure
surrounding case constructed to provide a degree of protection to personnel against accidental contact with
live parts and also the equipment enclosed against specified environmental conditions (IEC 61950:1997)
NOTE An enclosure can be subdivided into compartments.
3.3
junction point
connection point(s) between the medical supply unit and the system(s) already installed
3.4
medical gas
any gas or mixture of gases intended to be administered to patients for therapeutic, diagnostic or prophylactic
purposes, or for driving surgical tools
NOTE In some applications this term includes medical vacuum.
3.5
medical supply unit
fixed equipment intended to supply electric power and/or medical gases and/or liquids and anaesthetic gas
scavenging systems to medical areas of a health-care facility
NOTE Medical supply units can include medical electrical equipment or medical electrical systems or parts thereof.
Medical supply units can also consist of modular sections for electrical supply, lighting for therapy or illumination,
communication, supply of medical gases and liquids, anaesthetic gas scavenging systems. Some typical
examples of medical supply units are bed head services modules, ceiling pendants, beams, booms, columns
and pillars. Examples of configurations are given in Figures 101, 102 and 103.
4 General requirements and requirements for tests
4.1 Modifications to clause 3 of EN 60601-1:1990
Clause 3 of EN 60601-1:1990 applies with the following addition:
3.6 Add the following items:
3.6 aa) R An oxidant leak which is not detected by e.g. an alarm or periodic inspection shall be considered a
normal condition and not a single fault condition.
3.6 bb) Medical supply units shall, when transported, stored, installed, operated in normal use and maintained
according to the instructions of the manufacturer, cause no safety hazard which could be foreseen using risk
analysis procedures in accordance with EN ISO 14971 and which is connected with its intended application, in
normal condition and in single fault condition.
3.101 Equipment and components incorporated into the medical supply unit shall comply with the relevant
standard(s) for such equipment or components.
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ISO 11197:2004(E)
4.2 Clause 4 of EN 60601-1:1990
Clause 4 of EN 60601-1:1990 applies.
5 Classification
Clause 5 of EN 60601-1:1990 applies.
6 Identification, marking and documents
Clause 6 of EN 60601-1:1990 applies with the following amendments:
6.1 Marking on the outside of equipment or equipment parts
a) Mains-operated equipment
Replace with the following:
Mains-operated equipment, including separable components thereof which have a mains part, shall be
provided with permanent and legible marking on the outside of the major part of the equipment indicating the
origin and model or type reference.
g) Connection to the supply
Replace with the following:
Due to the possible complexity of external marking, diagrams indicating all electrical and electronic
connections to the medical supply unit shall be located at the junction point inside the equipment.
For electrical connections the diagram shall indicate voltages, number of phases and number of circuits. For
electronic connections, the diagram shall indicate connector numbers and wire identification.
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ISO 11197:2004(E)
k) Mains power output
Replace with the following:
Mains socket-outlets for special purposes (e.g. for x-ray equipment) shall be marked with: type of mains, rated
voltage, rated current and with a label (e.g."x-ray").
See Annex AA for Special National Conditions
NOTE 1 Mains socket-outlets for special purpose areas which are fused in a single circuit can be marked with identical
numbers.
Add the following:
When a medical supply unit is provided with socket-outlets for connection to an essential electrical supply
circuit [e.g. uninterruptable power supply (UPS)], these socket-outlets shall comply with the national
installation rules or be individually identified if not covered by those rules.
See Annex AA for Special National Conditions.
NOTE 2 If socket-outlets in the same location are supplied from different power sources, each source should be readily
identifiable.
l) Classification
Replace dash three with the following:
Medical supply units shall be designed and constructed as CLASS I, Type B equipment according to degree
of protection against electric shock. Built-in units of Type BF or CF and outlets forming part of them, contained
in medical supply units, shall be clearly marked with the relevant symbols according to appendix D, Table D II
of EN 60601-1:1990.
NOTE The term “Type B (BF, CF) equipment (unit)” used in this standard is equivalent to the term “Type B (BF, CF)
applied part” used in EN 60601-1.
y) Earth terminals
Add the following:
Facilities for the connection of supplementary equipotential earth bonding (if provided) shall be marked with
symbol 9 of appendix D, Table D I of EN 60601-1:1990.
NOTE The term "equipotential earth bonding" used in this standard is equivalent to the term "potential equalisation
conductor" used in EN 60601-1.
Add the following:
aa) Particular applications
If the medical supply unit is intended to be used in conjunction with patient monitors for electromyograph
and/or electroencephalograph and/or electrocardiograph, the medical supply unit shall be marked with the
particular application as follows:
 for electromyograph EMG
 for electroencephalograph EEG
 for electrocardiograph ECG or EKG
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ISO 11197:2004(E)
bb) Terminal units
 Terminal units for medical gases and vacuum shall be marked in accordance with EN 737-1 or national
regulations. Colour coding, if used, shall be in accordance with EN 737-1 or national regulations.
See Annex AA for Special National Conditions.
 Terminal units for anaesthetic gas scavenging systems shall be marked in accordance with EN 737-4 or
national regulations. Colour coding, if used, shall be in accordance with EN 737-4 or national regulations.
 Terminal units for liquids shall be marked with the name of the liquid in accordance with Table 101 or the
equivalent national language.
Table 101 — Marking for liquids
Name of liquid
Potable water, cold
Potable water, warm
Cooling water
Cooling water, feed-back
De-mineralized water
Distilled water
Dialysing concentrate
Dialysing permeate
6.2 Marking on the inside of equipment and equipment parts
Add the following:
aa) Junction points and pipelines for medical gases shall be marked in accordance with EN 737-3 or national
regulations. Colour coding, if used, shall be in accordance with EN 737-3 or national regulations.
See Annex AA for Special National Conditions.
bb) Junction points and pipelines for anaesthetic gas scavenging systems shall be marked in accordance with
EN 737-2 or national regulations. Colour coding, if used, shall be in accordance with EN 737-2 or national
regulations.
cc) Junction points and pipelines for liquids shall be marked with the name of the liquid in accordance with
Table 101 or the equivalent in national language.
dd) The neutral connection point within the medical supply unit shall be clearly identified using the letter N
and/or colour coded blue (See appendix D, Table D I, symbol 8 of EN 60601-1:1990, IEC 60364-5-51 and IEC
60446).
6.8 Accompanying documents
Clause 6.8 of EN 60601-1:1990 applies with the following amendments:
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ISO 11197:2004(E)
6.8.2 Instructions for use
a) General information
Add the following:
 Instructions for use shall state which parts of the equipment are capable of bearing additional loads. The
maximum safe working load shall be stated.
 If flexible hoses and hose assemblies are used for supplying medical gases, anaesthetic gas scavenging
or liquids in an operator-adjustable system (e.g. a ceiling pendant), the instructions for use shall include a
procedure for, and the recommended frequency of, inspection and replacement.
 If flexible hoses are used for supplying medical gases in an operator-adjustable system (e.g. a ceiling
pendant), the instructions for use shall state that the following tests given in EN 737-3 shall be carried out
following modification or replacement of the flexible hose:
...