SIST EN ISO 11197:2009

Medical supply units (ISO 11197:2004)

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.

Medizinische Versorgungseinheiten (ISO 11197:2004)

Abschnitt 1 der EN 60601-1:1990 gilt mit folgenden Abweichungen:
Diese Norm gilt für MEDIZINISCHE VERSORGUNGSEINHEIT nach 3.5.
Diese Besonderen Festlegungen gelten zusammen mit denen der EN 60601-1.
Die Anforderungen dieser Besonderen Norm haben Vorrang vor denen der EN 60601-1.

Gaines techniques à usage médical (ISO 11197:2004)

Enote za oskrbo v medicini (ISO 11197:2004)

General Information

• Status: Withdrawn
• Publication Date: 11-May-2009
• Withdrawal Date: 19-Apr-2016
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 20-Apr-2016
• Due Date: 13-May-2016
• Completion Date: 20-Apr-2016
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 11197:2009 - Medical supply units (ISO 11197:2004)

Relations

• Replaces: SIST EN ISO 11197:2005 - Medical supply units (ISO 11197:2004)
• Effective Date: 01-Jun-2009
• Replaced By: SIST EN ISO 11197:2016 - Medical supply units (ISO 11197:2016)
• Effective Date: 01-May-2016
• Replaced By: SIST EN ISO 11197:2016 - Medical supply units (ISO 11197:2016)
• Effective Date: 08-Jun-2022
• Replaces: SIST EN ISO 11197:2005 - Medical supply units (ISO 11197:2004)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11197:2009
01-junij-2009
1DGRPHãþD
SIST EN ISO 11197:2005
Enote za oskrbo v medicini (ISO 11197:2004)
Medical supply units (ISO 11197:2004)
Medizinische Versorgungseinheiten (ISO 11197:2004)
Gaines techniques à usage médical (ISO 11197:2004)
Ta slovenski standard je istoveten z: EN ISO 11197:2009
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 11197:2009 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11197:2009

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SIST EN ISO 11197:2009
EUROPEAN STANDARD
EN ISO 11197
NORME EUROPÉENNE
EUROPÄISCHE NORM
April 2009
ICS 11.040.10 Supersedes EN ISO 11197:2004
English Version
Medical supply units (ISO 11197:2004)
Gaines techniques à usage médical (ISO 11197:2004) Medizinische Versorgungseinheiten (ISO 11197:2004)
This European Standard was approved by CEN on 21 March 2009.
CEN 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 CEN Management Centre or to any CEN 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 CEN member into its own language and notified to the CEN Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11197:2009: E
worldwide for CEN national Members.

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SIST EN ISO 11197:2009
EN ISO 11197:2009 (E)
Contents Page
Foreword .3
Annex ZA (Informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4

2

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SIST EN ISO 11197:2009
EN ISO 11197:2009 (E)
Foreword
The text of ISO 11197:2004 has been prepared by Technical Committee ISO/TC 121 “Anaesthetic and
respiratory equipment” of the International Organization for Standardization (ISO) and has been taken over as
EN ISO 11197:2009 by Technical Committee CEN/TC 215 “Respiratory and anaesthetic equipment” the
secretariat of which is held by BSI.
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 October 2009, and conflicting national standards shall be withdrawn at
the latest by March 2010.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11197:2004.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive.
For relationship with EC Directive, see informative Annex ZA, which is an integral part of this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 11197:2004 has been approved by CEN as a EN ISO 11197:2009 without any modification.
3

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SIST EN ISO 11197:2009
EN ISO 11197:2009 (E)
Annex ZA
(Informative)

Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Communities under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.

Table ZA.1 – Correspondence between this European Standard and EU Directives

Clause(s)/sub-clause(s) of this Essential Requirements (ERs) of Qualifying
EN Directive 93/42/EEC remarks/Notes

All 1 (1st paragraph), 1 (2nd paragraph 1st
dash), 1 (2nd paragraph 2nd dash)
All 2
All 3
4 6,9.3
6.1a) 13.3a)

6.1g) 13.3a), 13.3b)

6.1k) 13.2, 13.3a), 13.3b)
6.1l) 13.3b)
6.1y) 13.2, 13.3b)
6.1aa) 13.2, 13.3b)
6.2 7.6, 9.1
6.8 7.1, 13.1, 13.4, 13.6a), b), c), d)
6.8.2 13.1, 13.6a), b), c), d)
6.8.2a) 13.4
6.8.3 13.1
Section 3 12.6
Section 4 12.7.1
21.101 4, 9.2
21.101.2 9.2
21.101.3 9.2
26.101 12.7.2, 12.7.3
36.101 12.5
42 12.7.5
4

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SIST EN ISO 11197:2009
EN ISO 11197:2009 (E)
42.101 12.7.5
43 7.1, 9.3
43.2 7.1, 9.3
56.1 9.2, 12.6
57.1 9.2, 12.6
57.2 9.2, 12.6
57.6 9.2, 12.6
58.101 9.2, 12.6
59.101.1 12.7.4
59.101.1a) 7.1, 7.3
59.101.2 7.3, 12.7.4
59.101.2a) 7.3
59.101.2c) 7.5
59.102.2c) 7.5
59.103.1a) 7.1, 7.3
59.103.1b) 7.1, 7.3
59.103.1c) 7.1, 7.3
59.103.2b) 7.5
59.104.1 9.1, 12.7.4
59.104.2 9.1, 12.7.4
59.104.3a) 9.1
59.104.3e) 7.1, 7.3
59.104.3g) 9.1
- 13.6q) This relevant Essential
Requirement is not
addressed in this European
Standard : covered by EN
ISO 13485: 2003, subclause
4.2.3

WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
5

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SIST EN ISO 11197:2009
EN ISO 11197:2009 (E)
For devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC on Machinery,
in accordance with Article 3 of Directive 93/42/EEC the following table ZA.2 details the relevant essential
requirements of Directive 2006/42/EC on Machinery to the extent to which they are more specific than those
of Directive 93/42/EEC along with the corresponding clauses of this European Standard. Table ZA.2,
however, does not imply any citation in the OJEU under the machinery directive and thus does not provide
presumption of conformity for the machinery directive.
Table ZA.2 – Relevant Essential Health and Safety Requirements from Directive 2006/42/EC on
machinery that are addressed by this European Standard
(according to article 3 of amended Directive 93/42/EEC)

Clause(s)/sub-clause(s) of this Essential Health and Safety Qualifying remarks/Notes
EN Requirements (EHSRs) of
Directive 2006/42/EC
- 1.1.4 This relevant Essential Requirement is
not addressed in this European
Standard. To be addressed by
EN14971 and in some cases portions
of EN 60601-1;3rd ed.
- 1.2.2 This relevant EHSR is not specifically
addressed in this European standard;
only partially covered by EN 60601-1-
6 and EN 14971
- 1.5.4 This relevant EHSR is not specifically
addressed in this European standard;
only partially covered in EN 14971
and EN 62366
- 1.6.1 This relevant EHSR is only partly
addressed in subclause 6.8.2 of this
European standard; see EN 60601-1
and EN 14971
- 1.6.2 This relevant EHSR is not addressed
in this European standard; see EN
60601-1 and EN 14971
- 1.6.3 This relevant Essential Requirement is
not addressed in this European
Standard.
- 3.4.5 This relevant EHSR is not specifically
addressed in this European standard:
it is partially covered in EN 60601-1
and EN 14971
- 3.6.2 This relevant Essential Requirement is
not addressed in this European
Standard

6

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SIST EN ISO 11197:2009


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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SIST EN ISO 11197:2009
ISO 11197:2004(E)
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ii © ISO 2004 – All rights reserved

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SIST EN ISO 11197:2009
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.
© ISO 2004 – All rights reserved iii

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SIST EN ISO 11197:2009
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

iv © ISO 2004 – All rights reserved

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SIST EN ISO 11197:2009
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
© ISO 2004 – All rights reserved v

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SIST EN ISO 11197:2009
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

vi © ISO 2004 – All rights reserved

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SIST EN ISO 11197:2009
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.
© ISO 2004 – All rights reserved vii

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SIST EN ISO 11197:2009
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.
viii © ISO 2004 – All rights reserved

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SIST EN ISO 11197:2009
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
...