SIST EN ISO 11197:2016

SLOVENSKI STANDARD
SIST EN ISO 11197:2016
01-maj-2016
1DGRPHãþD
SIST EN ISO 11197:2009
Enote za oskrbo v medicini (ISO 11197:2016)
Medical supply units (ISO 11197:2016)
Medizinische Versorgungseinheiten (ISO 11197:2016)
Gaines techniques à usage médical (ISO 11197:2016)
Ta slovenski standard je istoveten z: EN ISO 11197:2016
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 11197:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11197:2016

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SIST EN ISO 11197:2016


EN ISO 11197
EUROPEAN STANDARD

NORME EUROPÉENNE

March 2016
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 11197:2009
English Version

Medical supply units (ISO 11197:2016)
Gaines techniques à usage médical (ISO 11197:2016) Medizinische Versorgungseinheiten (ISO 11197:2016)
This European Standard was approved by CEN on 25 December 2015.

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-CENELEC 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-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11197:2016 E
worldwide for CEN national Members.

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SIST EN ISO 11197:2016
EN ISO 11197:2016 (E)
Contents Page
European 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 11197:2016
EN ISO 11197:2016 (E)
European foreword
This document (EN ISO 11197:2016) has been prepared by Technical Committee
CEN/TC 215 “Respiratory and anaesthetic equipment”, the secretariat of which is held by BSI, in
collaboration with Technical Committee ISO/TC 121 “Anaesthetic and respiratory equipment”.
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 September 2016, and conflicting national standards
shall be withdrawn at the latest by March 2019.
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 11197:2009.
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 EU Directive(s).
For relationship with EU Directive(s), 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,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11197:2016 has been approved by CEN as EN ISO 11197:2016 without any modification.

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SIST EN ISO 11197:2016
EN ISO 11197:2016 (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 Directive 93/42/EEC.
Once this standard is cited in the Official Journal of the European Union under that Directive and has
been implemented as a national standard in at least one Member State, compliance with the normative
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 relevant Essential Requirements of that Directive.
NOTE When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Essential Qualifying remarks/Notes
Requirements
Clause(s)/subclause(s) of this EN
(ERs) of Directive
93/42/EEC
201.4 7.1 (first and
second indents)
201.5
201.6
201.8
201.9
201.11.7
201.12
201.13
201.15
201.13 7.3 (up to
semicolon)
201.15.4.101
201.15.4.102
201.15.4.103
201.11
201.7.2.1 9.1 (first sentence)
201.8
201.9.1
201.16
201.15
201.5.9.2.3 9.2 (first and Adds specific requirements
second indents)
201.6 Mandates 60601-2
201.8
201.9
201.10
201.17
202
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SIST EN ISO 11197:2016
EN ISO 11197:2016 (E)
201.8 9.3
201.11
201.11.2
201.12
201.13
201.15
201.16
201.15.101
201.10 11
201.14 12.1
201.14 12.1 a)
201.17 12.5
202
201.6.2 12.6
201.8
201.13
201.16
201.9 12.7.1
201.15
201.9.6 12.7.2
201.9.8
201.9.6 12.7.3
201.7 12.7.4 Only covered for gas connectors
201.7.2.8
201.15.4.101
201.4 12.7.5
201.11.1
201.7 12.9
201.7 13.1
201.7.2 13.3 a)
201.7.9.2 13.6 a) Covers item in 13.3 a) only
201.7.9.2 13.6 d)
201.7.9.2.16 13.6 i)
201.7.9.2.1 13.6 q)
NOTE Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with the Medical Devices Directive 93/42/EEC. This means that
RISKS have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’,
according to the wording of the corresponding essential requirement.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.

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SIST EN ISO 11197:2016

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SIST EN ISO 11197:2016
INTERNATIONAL ISO
STANDARD 11197
Third edition
2016-02-15
Medical supply units
Gaines techniques à usage médical
Reference number
ISO 11197:2016(E)
©
ISO 2016

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SIST EN ISO 11197:2016
ISO 11197:2016(E)

COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
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Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved

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SIST EN ISO 11197:2016

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SIST EN ISO 11197:2016
ISO 11197:2016(E)
Contents
Foreword . v
Introduction . viii
201.1 Scope,object and related standards . 1
201.1.1 Scope . 1
201.1.2 Object . 1
201.1.3 Related standards. 1
201.1.3.1 Collateral standards . 1
201.1.3.2 Particular standards . 2
201.2 Normative references . 2
201.3 Terms and definitions . 4
201.4 General requirements . 5
201.5 General requirements for testing ME EQUIPMENT . 5
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 5
201.7 ME EQUIPMENT identification, marking and documents . 5
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 9
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 15
201.10 Protection against unwanted and excessive radiation HAZARDS . 17
201.11 Protection against excessive temperatures and other HAZARDS . 17
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 17
201.13 HAZARDOUS SITUATIONS and fault conditions . 17
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 18
201.15 Construction of ME EQUIPMENT . 18
201.16 ME SYSTEMS . 23
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 23
202 MEDICAL ELECTRICAL EQUIPMENT - part 1-2 General requirements for BASIC SAFETY and ESSENTIAL
PERFORMANCE – Collateral standard: Electromagnetic disturbances – Requirements and tests . 23
206 MEDICAL ELECTRICAL EQUIPMENT - part 1-6 General requirements for BASIC SAFETY and ESSENTIAL
PERFORMANCE – Collateral standard: Usability . 23
Annex AA (informative) Rationale . 24
Bibliography . 25
iv © ISO 2016 – All rights reserved

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SIST EN ISO 11197:2016
ISO 11197:2016(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.
The procedures used to develop this document and those intended for its further maintenance are described in
the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO
documents should be Noted. This document was drafted in accordance with the editorial rules of the ISO/IEC
Directives, Part 2. www.iso.org/directives
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. Details of any patent rights
identified during the development of the document will be in the Introduction and/or on the ISO list of patent
declarations received. www.iso.org/patents
Any trade name used in this document is information given for the convenience of users and does not constitute
an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO's adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword ‐ Supplementary information
The committee responsible for this document is ISO/TC 121.
ISO 11197 was prepared by the European Committee for Standardization (CEN) Technical Committee
CEN/TC 215, Respiratory and anaesthetic equipment, in collaboration with ISO Technical Committee 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).
This third edition cancels and replaces the second edition (ISO 11197:2004), which has been technically revised.
© ISO 2016 – All rights reserved v

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SIST EN ISO 11197:2016
ISO 11197:2016(E)
Introduction
Many healthcare facilities use surface‐mounted or recessed containment systems and ENCLOSURES for
accommodating and displaying essential PATIENT care services. These are known as MEDICAL SUPPLY UNITS.
This International Standard specifies requirements for MEDICAL SUPPLY UNITS manufactured in factories or
assembled from components on site.
It is intended for use by those persons involved in the design, construction, inspection, testing, maintenance and
operation of healthcare facilities as well as those manufacturing, assembling and installing MEDICAL SUPPLY UNITS.
Persons involved in the design, manufacture, installation, maintenance and testing of equipment intended to be
connected to MEDICAL GAS, vacuum, ANAESTHETIC GAS SCAVENGING and/or PLUME EXTRACTION SYSTEMS should be aware of
the contents of this document.
This International Standard is a particular standard, based on IEC 60601‐1:2005+A1:2012. IEC 60601‐
1:2005+A1:2012 is the basic standard for the safety of all MEDICAL ELECTRICAL EQUIPMENT used by or
under the supervision of qualified personnel in the general medical and PATIENT environment; it also
contains certain requirements for reliable operation to ensure safety.
IEC 60601‐1:2005+A1:2012 has associated collateral standards and particular standards. The collateral standards
include requirements for specific technologies and/or HAZARDS and apply to all applicable equipment, such as
medical systems, EMC, radiation protection in diagnostic X‐ray equipment, software, etc. The particular standards
apply to specific equipment types, such as medical electron accelerators, high frequency surgical equipment,
hospital beds, etc.
NOTE Definitions of collateral standard and particular standard can be found in IEC 60601:2005+A1:2012.
For an explanation of the special numbering in this document and more on the terms “collateral”, “particular” and
“general” standards, see 201.1.3, 201.1.4, and 201.1.5.
Annex AA contains rationale statements for some of the requirements of this International Standard. It is included
to provide additional insight into the reasoning that led to the requirements and recommendations that have been
incorporated in this International Standard. The clauses and subclauses marked with (*) after their number have a
corresponding rationale contained in Annex AA.
vi © ISO 2016 – All rights reserved

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SIST EN ISO 11197:2016
INTERNATIONAL STANDARD ISO 11197:2016(E)

Medical supply units

201.1 Scope, object and related standards
IEC 60601-1:2005+A1:2012, Clause 1 applies except as follows:
201.1.1 Scope
IEC 60601-1:2005+A1:2012, 1.1 is replaced by:
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL SUPPLY UNITS,
hereafter also referred to as ME EQUIPMENT.
This International Standard applies to MEDICAL SUPPLY UNITS manufactured within a factory or assembled on site,
including cabinetry and other ENCLOSURES, which incorporate PATIENT care services.
NOTE 1 A party that assembles on site various components intended for PATIENT care services into an
ENCLOSURE is considered the MANUFACTURER of the MEDICAL SUPPLY UNIT.
HAZARDS inherent in the intended function of ME EQUIPMENT or ME SYSTEMS within the scope of this International
Standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of IEC 60601‐
1:2005+A1:2012 (see 201.1.4).
NOTE 2 See also IEC 60601‐1:2005+A1:2012, 4.2.
201.1.2 Object
IEC 60601-1:2005+A1:2012, 1.2 is replaced by:
The object of this International Standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for MEDICAL SUPPLY UNITS as defined in 201.3.103.
201.1.3 Related standards
201.1.3.1 Collateral standards
IEC 60601-1:2005+A1:2012, 1.3 applies with the following addition:
This particular standard refers to those applicable collateral standards that are listed in
IEC 606011:2005+A1:2012, Clause 2 as well as 201.2 of this particular standard.
© ISO 2016 – All rights reserved 1

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SIST EN ISO 11197:2016
ISO 11197:2016(E)
IEC 60601‐1‐3:2008, IEC 60601‐1‐8:2006+A1:2012, IEC 60601‐1‐9:2007, and IEC 60601‐1‐10:2007+A1:2013 do
not apply.
NOTE Collateral standards are referred to by their document numbers.
201.1.3.2 Particular standards
IEC 60601-1:2005+A1:2012, 1.4 applies with the following additions:
The numbering of sections, clauses and subclauses of this particular standard corresponds to that of IEC 60601‐
1:2005+A1:2012 with the prefix “201” (e.g. 201.1 in this standard addresses the content of IEC 60601‐
1:2005+A1:2012 Clause 1) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of
the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4
of the IEC 60601‐1‐2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the
IEC 60601‐1‐3 collateral standard, etc.). The changes to the text of IEC 60601‐1:2005+A1:2012 are specified by
the use of the following words:
 “Replacement” means that the clause or subclause of IEC 60601‐1:2005+A1:2012 or applicable
collateral 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
IEC 60601‐1:2005+A1:2012 or applicable collateral standard.
 “Amendment” means that the clause or subclause of IEC 60601‐1:2005+A1:2012 or applicable
collateral standard is amended as indicated by the text of this particular standard.
Subclauses or figures which are additional to those of IEC 60601‐1:2005+A1:2012 are numbered starting from
201.101. Additional Annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
Subclauses or figures which are additional to those of a collateral standard are numbered starting from 20x,
where “x” is the number of the collateral standard, e.g. 202 for IEC 60601‐1‐2, 203 for IEC 60601‐1‐3, etc.
The term “this standard” is used to make reference to IEC 60601‐1:2005+A1:2012, any applicable collateral
standards and this particular standard taken together.
Where there is no corresponding section, clause or subclause in this particular standard, the section, clause or
subclause of IEC 60601‐1:2005+A1:2012 or applicable collateral standard, although possibly not relevant, applies
without modification; where it is intended that any part of IEC 60601‐1:2005+A1:2012 or applicable collateral
standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular
standard.
201.2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable
for its application. For dated references, only the edition cited applies. For undated references, the latest edition of
the referenced document (including any amendments) applies.
NOTE Informative references are listed in the Bibliography on page 25.
IEC 60601-1:2005+A1:2012, Clause 2 applies and IEC 60601-1-2:2014, Clause 2 applies, with the following additions:
IEC 60364‐5‐54:2011, Electrical installations of buildings — Part 5-54: Selection and erection of electrical
equipment; Earthing arrangements, protective conductors and protective bonding conductors
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SIST EN ISO 11197:2016
ISO 11197:2016(E)
IEC 60364‐7‐710:2002, Electrical installations of buildings — Part 7-710: Requirements for special
installations or locations; Medical locations
IEC 60529:1989+AMD1:1999 +AMD2:2013 CSV/COR2:2015, Degrees of protection provided by
enclosures (IP Code)
IEC 60598‐1:2014, Luminaires — Part 1: General requirements and tests
IEC 60601‐1:2005+A1:2012, Medical electrical equipment — Part 1: General requirements for basic
safety and essential performance
IEC 60601‐1‐2:2014 Medical electrical equipment — Part 1-2: General requirements for basic safety and
essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
IEC 60601‐1‐3:2008, Medical electrical equipment — Part 1: General requirements for safety 3. Collateral
Standard: General Requirements for Radiation Protection in Diagnostic X-Ray Equipment
IEC 60601‐1‐6:2010, Medical electrical equipment — Part 1-6: General requirements for basic safety and
essential performance — Collateral standard: Usability
IEC 60601‐1‐8:2006+A1:2012, Medical electrical equipment — Part 1-8: General requirements for basic
safety and essential performance — Collateral Standard: General requirements, test and guidance for
alarm systems in medical electrical equipment and medical electrical systems
IEC 60601‐1‐9:2007, Medical electrical equipment — Part 1-9: General requirements for basic safety and
essential performance — Collateral Standard: Requirements for environmentally conscious design
IEC 60601‐1‐10:2007, Medical electrical equipment — Part 1-10: General requirements for basic safety
and essential performance — Collateral Standard: Requirements for the development of physiologic
closed-loop controllers
IEC 61386‐1:2008, Conduit systems for cable management — Part 1: General requirements
IEC 61950:2007, Cable management systems — Specifications for conduit fittings and accessories for
cable installations for extra-heavy duty electrical steel conduit
ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels of noise sources
using sound pressure — Engineering methods for an essentially free field over a reflecting plane
ISO 5359:2014, Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with
medical gases
ISO 7396‐1:2007, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases
and vacuum
ISO 7396‐2:2007, Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems
ISO 9170‐1:2008, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with
compressed medical gases and vacuum
ISO 9170‐2:2008, Terminal units for medical gas pipeline systems — Part 2: Terminal units for
anaesthetic gas scavenging systems
ISO 14971:2007, Medical devices — Application of risk management to medical devices
© ISO 2016 – All rights reserved 3

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SIST EN ISO 11197:2016
ISO 11197:2016(E)
ISO 16571:2014, Systems for evacuation of plume generated by medical devices
EN 50174‐1:2009 + A2:2014, Information technology. Cabling installation — Part 1: Installation specification and
quality assurance
EN 50174‐2:2009+ A2:2014, Information technology. Cabling installation — Part 2: Installation planning and
practices inside buildings
201.3 Terms and definitions
For the purpose of this document, the terms and definitions given in IEC 60601‐1:2005+A1:2012,
ISO 16571:2014, ISO 7396‐1:2007 and the following apply.
NOTE An alphabetical index of defined terms is found at the end of this document.
Replacement of 3.26:
201.3.26
ENCLOSURE
surrounding case constructed to provide a degree of protection to personnel against accidental contact
with live parts and also the enclosed equipment against specified environmental conditions
Note 1 to entry: See IEC 61950:2007, 3.15.
Note 2 to entry: An ENCLOSURE can be subdivided into COMPARTMENTS.
Addition:
201.3.101
COMPARTMENT
part of an ENCLOSURE with openings necessary for interconnection, control or ventilation
201.3.102
JUNCTION POINT
connection point(s) between the MEDICAL SUPPLY UNIT and the system(s) already installed
201.3.103
MEDICAL SUPPLY UNIT
permanently installed ME EQUIPMENT intended to supply electric power, communication means
(telephone, call systems, etc.), data transmission, lighting, and/or MEDICAL GASES and/or liquids, an
ANAESTHETIC GAS SCAVENGING SYSTEM and/or a PLUME EVACUATION SYSTEM to medical areas of a healthcare
facility
Note 1 to entry: MEDICAL SUPPLY UNITS can include ME EQUIPMENT or ME 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, PLUME EVACUATION SYSTEMS and ANAESTHETIC GAS SCAVENGING SYSTEMS. Some
typical examples of MEDICAL SUPPLY UNITS are bed head service modules, ceiling pendants, beams, booms, columns,
pillars, cabinetry, concealed COMPARTMENTS on or in a wall and prefabricated walls.
Note 2 to entry: Examples of configurations are given in Figures 201.103, 201.104 and 201.105.
4 © ISO 2016 – All rights reserved

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SIST EN ISO 11197:2016
ISO 11197:2016(E)

201.3.104
PLUME EVACUATION SYSTEM
PES
device for capturing, transporting, and filtering plume and exhausting the filtered product
Note 1 to entry: PLUME EVACUATION SYSTEMS can also be called smoke evacuators, laser plume evacuators, plume
scavengers, and local exhaust ventilators (LEVs).
201.4 General requirements
IEC 60601-1:2005+A1:2012, Clause 4 applies.
201.5 General requirements for testing ME EQUIPMENT
IEC 60601-1:2005+A1:2012, Clause 5 applies with the following additions:
201.5.9.2.3 Actuating mechanisms
All external surfaces shall conform to a degree of protection against direct contact in normal operation of at least
IP2X or IPXXB. See IEC 605
...