EN ISO 11197:2019

SLOVENSKI STANDARD
01-februar-2020
Nadomešča:
SIST EN ISO 11197:2016
Enote za oskrbo v medicini (ISO 11197:2019)
Medical supply units (ISO 11197:2019)
Medizinische Versorgungseinheiten (ISO 11197:2019)
Gaines techniques à usage médical (ISO 11197:2019)
Ta slovenski standard je istoveten z: EN ISO 11197:2019
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 11197
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2019
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 11197:2016
English Version
Medical supply units (ISO 11197:2019)
Gaines techniques à usage médical (ISO 11197:2019) Medizinische Versorgungseinheiten (ISO 11197:2019)
This European Standard was approved by CEN on 15 September 2019.

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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, 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: Rue de la Science 23, B-1040 Brussels
© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11197:2019 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11197:2019) has been prepared by Technical Committee ISO/TC 121
"Anaesthetic and respiratory equipment" in collaboration with 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 May 2020, and conflicting national standards shall be
withdrawn at the latest by May 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11197:2016.
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, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 11197:2019 has been approved by CEN as EN ISO 11197:2019 without any modification.

INTERNATIONAL ISO
STANDARD 11197
Fourth edition
2019-11
Medical supply units
Gaines techniques à usage médical
Reference number
ISO 11197:2019(E)
©
ISO 2019
ISO 11197:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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 the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 11197:2019(E)
Contents Page
Foreword . iv
Introduction . v
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 General and Collateral standards . 1
201.1.3.2 Particular standards . 2
201.2 Normative references . 2
201.3 Terms and definitions . 3
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 . 6
201.8 Protection against electrical hazards from ME equipment . 10
201.9 Protection against mechanical hazards of ME equipment and ME systems . 17
201.10 Protection against unwanted and excessive radiation hazards . 20
201.11 Protection against excessive temperatures and other hazards . 20
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 21
201.13 Hazardous situations and fault conditions . 21
201.13.2.2 Single fault conditions . 21
201.14 Programmable electrical medical systems (PEMS) . 22
201.15 Construction of ME equipment . 22
201.16 ME systems . 27
201.17 Electromagnetic compatibility of ME equipment and ME systems . 27
202 Medical electrical equipment — Parts 1-2 General requirements for basic safety and
essential performance — Collateral standard: Electromagnetic disturbances — Requirements
and tests . 27
206 Medical electrical equipment — Parts 1-6 General requirements for basic safety and
essential performance — Collateral standard: Usability. 27
Annex A A (informative)  Rationale . 28
Annex B B (informative)  Tests during production . 29
Annex C C (informative)  Documentation . 33
Annex D D (informative)  Terminology — Alphabetical index of defined terms . 34
Bibliography . 36

iii
ISO 11197:2019(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 (see 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 (see 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 of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the World
Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 6, Medical gas supply systems.
This fourth edition cancels and replaces the third edition (ISO 11197:2016), which has been technically
revised. The main changes compared to the previous edition are as follows:
— editorial revision;
— change in the requirements defining the inclusion of USB outlets within medical supply units;
— addition of methods of internal cabling connections and specific tests including but not limited to
impact resistance.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
ISO 11197:2019(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 document 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 gas for medicinal use, medical device gas, vacuum, anaesthetic gas scavenging
and/or plume extraction systems should be aware of the contents of this document.
This document 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, electromagnetic compatibility (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, 201.1.3.1, 201.1.3.2.
Annex AA contains rationale statements for some of the requirements of this document. It is included to
provide additional insight into the reasoning that led to the requirements and recommendations that
have been incorporated in this document. The clauses and subclauses marked with (*) after their number
have a corresponding rationale contained in Annex AA.
In this document, the following print types are used:
— requirements, compliance with which can be verified, and definitions: roman type;
— informative material appearing outside of tables, such as notes, examples and references: in smaller
roman type. Normative text of tables is also in a smaller roman type;
— test methods: italic type;
— terms defined in clause 3 of the general standard, in this document or as noted: italic type.

v
INTERNATIONAL STANDARD ISO 11197:2019(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 document applies to the basic safety and essential performance of medical supply units, hereafter also
referred to as ME equipment.
This document 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
document are not covered by specific requirements in this standard, except in of IEC 60601-
1:2005+A1:2012, 7.2.13 and 8.4.1 (see 201.1.4).
NOTE 2 Refer to 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 document is to establish particular basic safety and essential performance requirements
for medical supply units as defined in 201.3.201.
201.1.3 Related standards
201.1.3.1 General and Collateral standards
IEC 60601-1:2005+A1:2012, 1.3 applies as the General Standard with the following addition:
This particular standard refers to those applicable collateral standards that are listed in IEC 60601-
1:2005+A1:2012, Clause 2 as well as 201.2 of this particular standard.
IEC 60601-1-3:2008+A1:2013, IEC 60601-1-8:2006+A1:2012, IEC 60601-1-9:2007,
IEC 60601-1-10:2007+A1:2013 and IEC 60601-1-11 and IEC 60601-1-12 do not apply.
NOTE Collateral standards are referred to by their document numbers.
ISO 11197:2019(E)
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 are referred to in the text in such a way that some or all of their content
constitutes requirements 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.
IEC 60364-7-710:2002, Electrical installations of buildings — Part 7-710: Requirements for special
installations or locations - Medical locations
IEC 60598-1:2014+A1:2017 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 disturbances – Requirements and tests
ISO 11197:2019(E)
IEC 60601-1-3:2008+A1:2013, Medical electrical equipment — Part 1-3: General requirements for basic
safety and essential performance – Collateral standard: Radiation protection in diagnostic X-Ray equipment
IEC 60601-1-6:2010+A1:2013, Medical electrical equipment — Part 1-6: General requirements for basic
safety and essential performance — Collateral standard: Usability
IEC 61386-1:2008+A1:2017, Conduit systems for cable management — Part 1: General requirements
IEC 62684:2018, Interoperability specifications of common external power supply (EPS) for use with data-
enabled mobile telephones
ISO 32, Gas cylinders for medical use - Marking for identification of content
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 7396-1:2016, 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 9170-1:2017, 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 14971:2019, Medical devices — Application of risk management to medical devices
ISO 16571:2014, Systems for evacuation of plume generated by medical devices
EN 50174-1:2018, Information technology. Cabling installation — Part 1: Installation specification and
quality assurance
EN 50174-2:2018, Information technology. Cabling installation — Part 2: Installation planning and
practices inside buildings
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005+A1:2012,
ISO 16571:2014, ISO 7396-1:2016 and the following apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
NOTE An alphabetical index of defined terms is found at the end of this document.
ISO 11197:2019(E)
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: The environmental conditions are referenced in IEC 61950:2007, 3.15.
Note 2 to entry: An enclosure can be subdivided into compartments.
Addition:
201.3.63
medical electrical equipment
ME equipment
Note 1 to entry: medical supply units may be connected to more than one supply mains.
Addition:
201.3.67
multiple socket-outlet
Note 1 to entry: Medical supply units are not considered as a multiple socket outlet.
201.3.201
medical supply unit
permanently installed ME equipment intended to supply electric power, communication means
(telephone, call systems, etc.), data transmission, lighting, and/or gas for medicinal use, medical device gas
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 gas for medicinal use, medical device gas 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, wall mounted enclosure for area shut-off valve boxes of the medical gas pipeline
system, joinery, 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.
201.3.202
junction point
connection point(s) between the medical supply unit and the inter-connecting system(s) already installed
201.3.203
compartment
area within an enclosure which is created by separating barriers, walls and covers forming its own cellular
section
ISO 11197:2019(E)
201.4 General requirements
IEC 60601-1:2005+A1:2012, Clause 4 applies.
Addition
201.4.2.3.1 Hazards identified in the IEC 60601 series
The manufacturer shall undertake all tests as defined or referenced within this standard and Annex BB,
and record the results. National standards might also apply which require test and record keeping.
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 use of at least
IP2X or IPXXB. Refer to IEC 60529:1989+AMD1:1999+AMD2:2013 CSV/COR2:2015.
This level of protection to live parts shall not be compromised during maintenance of the medical gas
pipeline systems, anaesthetic gas scavenging systems, plume evacuation systems or liquid pipeline systems,
e.g. by the provision of covers, barriers or individual protection with a degree of protection of at least
IP2X or IPXXB. Refer to IEC 60529:1989+AMD1:1999+AMD2:2013 CSV/COR2:2015.
If requested by the healthcare facility (e.g. in psychiatric or paediatric units or prison healthcare facilities),
the manufacturer shall provide means to prevent inadvertent or unauthorized dismantling of medical
supply units.
201.5.101 Medical supply unit test results
The manufacturer shall test each medical supply unit. The test results shall be recorded and presented to
the responsible organization on request.
The manufacturer shall maintain legible records of all tests undertaken on each medical supply unit
according to applicable requirements subject to a minimum period of 5 years for compliance with this
document.
201.6 Classification of ME equipment and ME systems
IEC 60601-1:2005+A1:2012, Clause 6 applies, with the following additions:
201.6.1 Protection against electric shock
A medical supply unit shall be designed and constructed as class i.
ISO 11197:2019(E)
201.7 ME equipment identification, marking and documents
IEC 60601-1:2005+A1:2012, Clause 7 applies, with the following additions:
201.7.2.1 Minimum requirements for marking on ME equipment and on interchangeable
parts
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.
201.7.2.1.1 Terminal units
Terminal units for gas for medicinal use and medical device gas which are mounted within a medical supply
unit shall be obvious. Where decorative finishes are applied to the medical supply unit (e.g. graphics,
where the terminal unit is displayed as part of the graphic) the design shall ensure a plain surround to
unit of not less than 10 mm.
the protrusion hole for the terminal
— terminal units for medical gas, medical device gas pipeline systems shall be marked in accordance with
ISO 9170-1:2017. Colour coding, if used, shall be in accordance with ISO 9170-1:2017 and ISO 32.
— terminal units for anaesthetic gas scavenging systems shall be marked in accordance with ISO 9170-
2:2008. Colour coding, if used, shall be in accordance with ISO 9170-2:2008.
— terminal units for liquids for dialysis shall be marked with the name of the liquid in accordance with
Table 201.101 or with the equivalent national language.
— terminal units for plume evacuation shall be marked in accordance with ISO 16571:2014.
NOTE Regional or national regulations which apply to ME equipment identification, marking and documents
might exist.
Table 201.101 — 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
201.7.2.1.1 Minimum requirements for marking on medical supply units and
attachable parts.
Parts of medical supply units designed for additional loads shall be marked to show the maximum safe
working load specified by the manufacturer.
ISO 11197:2019(E)
NOTE Medical supply units can comprise various attachments such as rail systems for supporting medical
equipment, shelves, articulated equipment support arms, tracks for monitoring equipment and similar attachments.
201.7.2.6 Connection to the supply mains
Due to the possible complexity of external marking, information 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 information shall indicate voltages, number of phases, and differentiation
of circuits. For electronic connections, the information shall indicate connector numbers and wire
identification.
201.7.2.8 Output connectors
201.7.2.8.1 Mains power output
Mains socket-outlets for special purposes (e.g. for x-ray equipment) shall be marked with the type of
supply mains, rated voltage, rated current and with a label (e.g. “X-RAY”).
When a medical supply unit is provided with socket-outlets for connection to an essential electrical supply
circuit (e.g. uninterruptable power supply (UPS), a Medical IT system as defined in
IEC 60364-7-710:2002), these socket-outlets shall comply with the installation rules or be individually
identified if not covered by those rules.
If socket-outlets in the same location are supplied from different power sources, each source should be
readily identifiable.
NOTE Regional or national regulations can apply to the mains power outlet configurations.
Addition
201.7.2.8.2 USB Charging
Where Universal Serial Bus (USB) charging devices are installed within medical supply units they shall not
form part of a mains power socket assembly. USB charging devices should be stand-alone units wired on
a final circuit. The USB charging device shall comply with IEC 62684:2018 and conform to the
requirements for dedicated charging ports (DCP) of EN 62680-1-1:2015 to provide a nominal output
voltage not exceeding 5 V DC.
The facia plate shall be marked to indicate the following:
— symbol for nature of supply, for direct current only;
— rated current, in milliamperes or amperes;
— rated output voltage;
— labelled “for non medical use only” in the local language.
Where a USB charging device is intended to supply a medical device, the power supply source shall be
resilient, e g: UPS or Medical IT system. The facia plate shall be marked to indicate the following:

— symbol for nature of supply, for direct current only;
— rated current, in milliamperes or amperes;
ISO 11197:2019(E)
— rated output voltage;
— Medical Use Only.
201.7.2.19 Functional earth terminals
Facilities for the connection of protective equipotential bonding shall be marked with symbol 8 of
IEC 60601-1:2005+A1:2012, Annex D, Table D.
201.7.3 Marking on the inside of ME equipment or ME equipment parts
Junction points and pipelines for gas distribution systems shall be marked in accordance with ISO 7396-
1:2016. Colour coding, if used, shall be in accordance with ISO 7396-1:2016 or ISO 32.
Junction points and pipelines for anaesthetic gas scavenging systems shall be marked in accordance with
ISO 7396-2:2007. Colour coding, if used, shall be in accordance with ISO 7396-2:2007, ISO 32.
Junction points and pipelines for liquids shall be marked with the name of the liquid in accordance with
Table 201.101 or the equivalent in national language.
Junction points and pipelines for plume evacuation shall be marked in accordance with ISO 16571:2014.
supply unit has a terminal connecting the neutral line of the power supply, it shall be clearly
If the medical
identified using the sign A of IEC 60601-1:2005+A1:2012, Annex D.3, the letter N and/or be colour coded
blue.
201.7.8.1 Colours of indicator lights
Where electrical components such as indicators, control buttons and the like are incorporated into a
medical supply unit, the requirements of IEC 60 601-1:2005+A1:2012 shall be maintained.
NOTE 1 Where supply mains final circuit socket-outlets are incorporated within medical supply units, these are
generally only supplied by socket-outlet manufacturers from a general range without adaptation for healthcare use.
Where lamp/neon/Light Emitting Diode (LED) indicators are supplied as part of that assembly, the illumination
colour might not be in accordance with Table 2 of 60601-1:2005+A1:2012.
NOTE 2 The illumination of an indicator might not truly reflect the operational state of the socket-outlet or its
supply mains.
201.7.9 Accompanying documents
201.7.9.1 General
Replace the first dash in IEC 60601-1:2005+A1:2012, 7.9.1 with the following:
The accompanying documents shall include the following:
 the name or trade name and address of the manufacturer and the authorized representative where
the manufacturer does not have a registered place of business within the local market;
 a declaration of conformity by the manufacturer or on-site manufacturer of compliance with this
standard and that the manufacturer has satisfied the testing requirements.
ISO 11197:2019(E)
201.7.9.2 Instructions for use and maintenance
201.7.9.2.1 General
The instructions for use shall contain the date of issue or the latest revision of the instructions for use.
201.7.9.2.16 Reference to the technical description
General information
 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 as part of the gas distribution systems and liquids for
dialysis and/or are components of an anaesthetic gas scavenging system or a plume evacuation system
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.
Responsibility of the manufacturer
 The manufacturer shall document the manufacturing tests that have been performed on each medical
supply unit to demonstrate that the requirements of this standard have been met. This documentation
shall be retained and made available upon request.
Specifications for installation, use and maintenance
 Medical supply units shall be manufactured, tested, installed and used in compliance with this
standard and supported by the manufacturer’s instructions.
NOTE Refer to IEC 60364-7-710:2002 for information on this subject.
Where a medical supply unit incorporates a luminaire, it is recommended that consideration is given to
the mounting height of the luminaire portion such that it will meet user requirements for (task or general)
illumination, viewed luminance and access to services for maintenance or function.
201.7.9.3 Technical description
a) If flexible hoses are used for supplying gas for medicinal use and medical device gases in an operator-
adjustable system (e.g. a ceiling pendant), the instructions for use shall state that the following tests
given in ISO 7396-1:2016 shall be carried out following modification or replacement of the flexible
hose:
— test for leakage;
— test for obstruction;
— test for particulate contamination;
— test of flow and pressure drop;
— test for cross connection;
— test of gas identity.
ISO 11197:2019(E)
b) If flexible hoses are used for an anaesthetic gas scavenging system in an operator-adjustable system
(e.g. a ceiling pendant), the instructions for use shall state that the following tests given in ISO 7396-
2:2007 shall be carried out following modification or replacement of the flexible hose:
— test for leakage,
— test of flow and pressure drop.
c) If flexible hoses are used for supplying liquids (e.g. for dialysis) in an operator-adjustable system
(e.g. a ceiling pendant), the instructions for use shall state that the following test shall be carried out
following modification or replacement of the flexible hose:
— test for leakage.
— test for cross connections between pipelines for different liquids.
d) If flexible hoses are used for a plume evacuation system in an operator-adjustable system (e.g. a
ceiling pendant), the instructions for use shall state that the following test, given in ISO 16571:2014,
shall be carried out following modification or replacement of the flexible hose:
— test for leakage.
201.8 Protection against electrical hazards from ME equipment
IEC 60601-1:2005+A1:2012, Clause 8 applies, with the following additions:
201.8.1 Fundamental rule of protection against electric shock
Medical supply units shall be constructed so that the mechanisms, operable parts, parts which are live or
might become live in the event of a single fault condition are not accessible without the use of a key or
tool.
Luminaires installed in or mounted on medical supply units shall comply with IEC 60598-
1:2014+A1:2017.
201.8.6 Protection earthing, functional earthing and potential equalization of ME
equipment
201.8.6.2 Protective earth terminal
Typical examples for the earth conductor connection of medical supply units are shown in Figure 201.101.
Terminal units installed as part of a compressed gas distribution system, vacuum supply system, anaesthetic
gas scavenging system and plume evacuation system are not required to be connected to the earth terminal.
ISO 7396-1:2016 defines the requirements for earthing of such pipeline systems and their components.
If anti-static hoses are used, the electrical resistance of each anti-static hose shall not exceed 1 MΩ.
Where hoses are used, the extraneous metalwork of the terminal unit shall be connected to the common
earth bar or to the earthed enclosure of the medical supply unit.
ISO 7396-1:2016 requires that a medical gas pipeline system be connected to earth.
ISO 11197:2019(E)
Where medical supply units incorporate hose assemblies, the pipeline path to earth will be broken. A
terminal unit with a metallic/electrically conductive surface has to be connected to a protective earth
terminal or to the earthed enclosure.
All earth conductors of circuits from the existing supply mains and additional equipotential earth bonding
shall be individually connected in the medical supply unit to a common earth bar.

Key
1 Cupal (Cu/Al) washer 4 lock washer
(copper surface uppermost) 5 medical supply unit section (e.g. aluminium)
2 spring washer 6 medical supply unit section (e.g. ferrous)
3 cable bracket
Figure 201.101 — Typical examples for protective measures against loosening and corrosion of
potential equalization connectors and protective earth conductor facilities
201.8.6.7 Potential equalization conductor
At each medical location of Group 1 and above at least one potential equalization conductor, external
connector shall be provided within a medical supply unit which shall be attached to an appropriate
conductor.
ISO 11197:2019(E)
Typical examples for potential equalization conductor attachment the medical supply units are shown in
Figure 201.101.
201.8.6.101 Conductors
Protective earth conductors of mains socket outlets shall each have a conductance equivalent to that of the
phase conductor with a minimum value of conductance equivalent to 2,5 mm or AWG 14 of copper and
shall be individually connected to the common earth bar.
Protective equipotential bonding conductors connecting extraneous metal parts which form the enclosure
of the medical supply unit shall have a conductance equivalent to half of that of the phase conductor with
a minimum value of conductance equivalent to 2,5 mm or AWG 14 of copper.
Protective earth conductors supplying other internal components (e.g. lighting) shall each have a
conductance equivalent to that of its phase conductor with a minimum value of conductance equivalent
or AWG 14 of copper and shall be individually connected to the common earth bar.
to 2,5 mm
The earth bonding conductor of a potential equalization connector for the connection of external ME
equipment shall have a cross section of at least 4 mm or AWG 12 of copper between this connector and
the protective earth bus bar of the medical supply unit and shall be individually detachable from the
connector (See Figure 201.102).
201.8.6.102 Bus bar
All protective earth conductors of circuits from the existing supply mains in the medical supply unit shall
be connected to a bus bar with a conductance at least equivalent to that of 16 mm or AWG 6 copper.
Each medical supply unit shall be provided with a bus bar for the connection of all protective earth
connections of supply mains circuits and shall
— have a conductance at least equivalent to that of 16 mm or AWG 6 copper,
— be equipped with a terminal for connection to a protective earth conductor of at least 16 mm or
AWG 6 cross-sectional area,
— provide secure terminals with protection from unintentional loosening,
— provide facilities for connection of potential equalization connection conductor terminals (see
Figure 201.102 for an example), and
— have a terminal for the electrical installation infrastructure equipotential bonding conductor (PA)
connection without any detachable bridge.
The medical gas pipeline system shall not be used as a bus bar.
NOTE 1   A metal section of the medical supply unit of equivalent conductance can function as a bus bar.
NOTE 2   National regulations can require different wiring configurations.
NOTE 3   Within this document, reference is made
...