kSIST FprEN ISO 11197:2026

• Abstract:

  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.

• Status: Not Published
• Public Enquiry End Date: 17-Jun-2024
• ICS: 11.040.01 - Medical equipment in general
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 5020 - Formal vote (FV) (Adopted Project)
• Start Date: 30-Jul-2026
• Due Date: 17-Sep-2026
• Completion Date: 03-Aug-2026
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/565 - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
• Ref Project: FprEN ISO 11197 - Medical supply units (ISO/FDIS 11197:2026)

• Revises: SIST EN ISO 11197:2020 - Medical supply units (ISO 11197:2019)
• Effective Date: 14-Jun-2023

kSIST FprEN ISO 11197:2026 is a CEN draft standard for medical supply units. It sets particular requirements for the basic safety and essential performance of medical electrical equipment (ME equipment) used as fixed patient-care service units in healthcare facilities. It is written for manufacturers, on-site assemblers, installers, designers, inspectors, maintenance teams and healthcare organizations that specify or operate these units.

What does kSIST FprEN ISO 11197:2026 specify?

kSIST FprEN ISO 11197:2026 applies to medical supply units manufactured in a factory or assembled on site, including cabinetry and other enclosures that incorporate patient care services. It also treats the on-site assembler of components as the manufacturer.

The document is a particular standard based on IEC 60601-1:2005+A1:2012. It follows the IEC 60601 structure with clauses numbered 201.x, adds clauses 202 and 206 for electromagnetic compatibility and usability, and uses informative annexes for rationale, production tests, documentation and terminology.

It applies to the basic safety and essential performance of these units, while the document points readers back to IEC 60601-1 for the general framework. Hazards inherent in the intended function of the ME equipment or ME systems are handled through the IEC 60601-1-based approach rather than by separate special requirements in every case.

Annex	What it covers
Annex AA	Rationale for selected requirements
Annex BB	Tests during production
Annex CC	Documentation to retain and provide on request
Annex DD	Alphabetical index of defined terms

What are the key requirements of kSIST FprEN ISO 11197:2026?

kSIST FprEN ISO 11197:2026 is centered on enclosure safety, earthing, marking, mechanical strength, gas and liquid system construction, testing, and documentation. For a buyer or designer, the practical effect is that the unit is not just a furniture-like enclosure - it is treated as safety-related medical electrical equipment with defined installation, inspection and test obligations.

Electrical safety, access and classification

The medical supply unit shall be constructed as class I, and live parts or parts that may become live under single fault conditions shall not be accessible without a key or tool. External surfaces are required to provide at least IP2X or IPXXB protection against direct contact in normal use.

This matters because routine patient-area use and maintenance must not expose users to live parts. Luminaires installed in or on the unit are also tied to the luminaires standard, so lighting is not treated as a purely decorative accessory.

Marking and instructions for use

The document requires permanent and legible marking for the origin and type or model of the unit, and specific identification at junction points inside the equipment for electrical and electronic connections. Terminal units for gases, liquids and plume evacuation have to be identified using the named marking rules for each service.

Instructions for use must include the issue date or latest revision, the manufacturer details, a declaration of conformity, and the information needed for safe installation, maintenance and replacement of flexible hoses. In practice, this is the material a hospital engineering team uses to install the unit correctly and to keep records for later servicing.

Earthing and equipotential bonding

kSIST FprEN ISO 11197:2026 requires a protective earth arrangement with a common earth bar, separately connected conductors and facilities for equipotential bonding. It also requires a potential equalization connector at each medical location of Group 1 and above.

This is important because these units mix power, communications, medical gases and sometimes liquids within one enclosure. The standard also addresses antistatic hoses and requires a risk analysis where hoses are used, so electrostatic discharge is considered together with the gas or liquid system layout.

Mechanical strength and load carrying

The standard requires impact testing of the enclosure and the installed unit, including the case with terminal units and electrical outlets fitted. Parts intended to carry extra loads are tested against the manufacturer’s declared safe working load, and the load-bearing elements must stay functional after the test.

That means shelves, rails, equipment arms and similar attachments are not handled as general-purpose fittings. They need declared load data and proof that the unit can survive realistic knocks and supported loads in the installed environment.

Gas, liquid and scavenging system construction

The document gives detailed construction rules for medical gas pipeline systems, ANAESTHETIC GAS SCAVENGING SYSTEMS, liquid supply systems and plume evacuation systems. It controls the use of flexible hoses, hose assemblies, pipeline joints, temperature exposure, compartment separation and the relationship between electrical parts and service lines.

For users, this means flexible hoses are restricted to operator-adjustable portions, and when hoses are used the instructions must tell maintenance staff how often to inspect and replace them and which tests to repeat afterwards. The intent is to prevent hidden wear, cross-connections, leaks and accidental mixing of services inside the unit.

Testing, records and production control

The manufacturer shall test each medical supply unit and keep legible records. Annex BB then sets the routine production tests for electrical safety, gas and vacuum integrity, and liquid supply checks.

This is the part that supports factory release, acceptance by the responsible organization and later traceability. Annex CC tells the manufacturer what documentation must be filed, while Annex AA explains why selected requirements were written the way they were.

What terms does kSIST FprEN ISO 11197:2026 define?

• medical supply unit - permanently installed ME equipment that supplies services such as power, communication, lighting, medical gases, liquids, ANAESTHETIC GAS SCAVENGING SYSTEMs or plume evacuation to a healthcare area.
• junction point - the connection point between the medical supply unit and the interconnecting systems already installed in the facility.
• compartment - an area inside an enclosure formed by barriers, walls and covers to create its own section.
• enclosure - the surrounding case that protects people from accidental contact with live parts and protects the enclosed equipment from environmental conditions.
• medical electrical equipment (ME equipment) - the document uses this IEC 60601-1 term for the equipment class that the medical supply unit falls under.
• medical electrical system (ME system) - a set of connected ME equipment and related items that are treated together for safety.
• programmable electrical medical systems (PEMS) - medical electrical systems with programmable elements that remain under the IEC 60601-1 safety framework.
• terminal unit - the point in the system where gas, vacuum or liquid services connect to the medical supply unit.

Who uses kSIST FprEN ISO 11197:2026?

kSIST FprEN ISO 11197:2026 is used by manufacturers and by parties that assemble medical supply units on site. It is also relevant to electrical installers, medical gas specialists, building service engineers, quality managers, inspectors, maintenance teams and healthcare buyers.

Typical use cases include bedhead service modules, ceiling pendants, beams, booms, columns, pillars, wall-mounted enclosures, concealed compartments and prefabricated walls. It is also relevant where the unit carries terminal units, socket-outlets, lighting, communication systems, nurse call interfaces, gas pipeline components or liquid services.

What changed in kSIST FprEN ISO 11197:2026 from the previous edition?

This fifth edition cancels and replaces the fourth edition, ISO 11197:2019, and the foreword says it has been technically revised. The stated changes are:

• editorial revision
• transition of temporary healthcare facilities to permanent installations
• inclusion of requirements for anti-static hoses within medical supply units
• amendments following a scope-gap assessment against IEC 60601-1:2005+A1:2012

Which standards are used with kSIST FprEN ISO 11197:2026?

Reference	What it contributes
IEC 60601-1:2005+A1:2012	Base general standard for basic safety and essential performance
IEC 60601-1-2:2014	EMC requirements and tests
IEC 60601-1-6:2010+A1:2013	Usability requirements
IEC 60364-7-710:2002	Electrical installations in medical locations
IEC 60598-1:2014+A1:2017	Requirements and tests for luminaires
IEC 61386-1:2008+A1:2017	Conduit systems for cable management
IEC 62684:2018	USB charging interoperability
ISO 32	Identification of medical gas cylinder contents
ISO 3744:2010	Sound power measurement method
ISO 5359:2014	Low-pressure hose assemblies for medical gases
ISO 5367:2023	Breathing sets and connectors
ISO 7396-1:2016	Medical gas pipeline systems
ISO 7396-2:2007	ANAESTHETIC GAS SCAVENGING SYSTEMS
ISO 9170-1:2017	Terminal units for compressed medical gases and vacuum
ISO 9170-2:2008	Terminal units for anaesthetic gas scavenging systems
ISO 14971:2019	Risk management for medical devices
ISO 16571:2014	Plume evacuation systems
EN 50174-1:2018	Cabling installation quality assurance
EN 50174-2:2018	Cabling planning and practices inside buildings

The document also applies IEC 60601-1:2005+A1:2012, Annexes A to M, and adds clauses 202 and 206 for electromagnetic compatibility and usability.

What does the kSIST FprEN ISO 11197:2026 document contain?

kSIST FprEN ISO 11197:2026 contains clause-by-clause requirements for scope, terms, classification, marking, electrical safety, mechanical hazards, temperatures, fire-related issues, construction, ME systems and electromagnetic compatibility. It also includes figures showing protective earth and layout arrangements, typical medical supply unit configurations and the impact test setup.

Annex BB gives the production test program for protective earth, leakage current, dielectric strength, gas and vacuum integrity, and liquid supply checks. Annex CC lists the documentation the manufacturer files and provides on request, and Annex DD gives an alphabetical index of defined terms. These parts support design review, factory testing, acceptance, maintenance planning and audit work.

SLOVENSKI STANDARD
oSIST prEN ISO 11197:2024
01-junij-2024
Enote za oskrbo v medicini (ISO/DIS 11197:2024)
Medical supply units (ISO/DIS 11197:2024)
Medizinische Versorgungseinheiten (ISO/DIS 11197:2024)
Gaines techniques à usage médical (ISO/DIS 11197:2024)
Ta slovenski standard je istoveten z: prEN ISO 11197
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
oSIST prEN ISO 11197:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

oSIST prEN ISO 11197:2024
oSIST prEN ISO 11197:2024
DRAFT
International
Standard
ISO/DIS 11197
ISO/TC 121/SC 6
Medical supply units
Secretariat: ANSI
Gaines techniques à usage médical
Voting begins on:
2024-03-26
ICS: 11.040.01
Voting terminates on:
2024-06-18
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 11197:2024(en)
oSIST prEN ISO 11197:2024
DRAFT
ISO/DIS 11197:2024(en)
International
Standard
ISO/DIS 11197
ISO/TC 121/SC 6
Medical supply units
Secretariat: ANSI
Gaines techniques à usage médical
Voting begins on:
ICS: 11.040.01
Voting terminates on:
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
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NATIONAL REGULATIONS.
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RECIPIENTS OF THIS DRAFT ARE INVITED
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TO SUBMIT, WITH THEIR COMMENTS,
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NOTIFICATION OF ANY RELEVANT PATENT
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Published in Switzerland Reference number
ISO/DIS 11197:2024(en)
ii
oSIST prEN ISO 11197:2024
ISO/DIS 11197:2024(en)
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
oSIST prEN ISO 11197:2024
ISO/DIS 11197:2024(en)
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 fifth edition cancels and replaces the fourth edition (ISO 11197:2019), which has been technically
revised. The main changes compared to the previous edition are as follows:
— editorial revision;
— concerning the transition of temporary healthcare facilities to those which will become permanent
installations;
— inclusion in the requirements defining the use of anti-static hoses within medical supply units;
— inclusion of amendments following a scope gap assessment conducted against IEC 60601-
1:2005+A1:2012
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
oSIST prEN ISO 11197:2024
ISO/DIS 11197:2024(en)
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.
In order to fully understand this Particular Standard the reader is guided to read the Collateral Standard
IEC 60601-1:2005+A1:2012 in parallel.
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.
Where a healthcare facility is developed for temporary use, such as in a pandemic or other natural
disaster, the basic principles of this standard shall apply. Once the stage of critical use of the facility has
normalised the product remaining in use shall fulfil the requirements of this standard.
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
oSIST prEN ISO 11197:2024
oSIST prEN ISO 11197:2024
DRAFT International Standard ISO/DIS 11197:2024(en)

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 joinery, 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 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.
oSIST prEN ISO 11197:2024
ISO/DIS 11197:2024(en)
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
oSIST prEN ISO 11197:2024
ISO/DIS 11197:2024(en)
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 5367:2023, Anaesthetic and respiratory equipment – Breathing sets and connectors
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.
oSIST prEN ISO 11197:2024
ISO/DIS 11197:2024(en)
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, low level
waste gas extract ductwork systems and vents/grilles 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 SYSTEM. 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.
Note 3 to entry: Where in-patient care locations (bed spaces) are required within an acute healthcare
facility for dedicated purposes, for example mental health patients, prisons etc, care should be taken to
provide bedhead services arrangements including medical supply units which limit ligature points or
ease of access to services therein.
201.3.202
junction point
connection point(s) between the medical supply unit and the inter-connecting system(s) already
installed
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ISO/DIS 11197:2024(en)
201.3.203
compartment
area within an enclosure which is created by separating barriers, walls and covers forming its own
cellular section
201.4 General requirements
IEC 60601-1:2005+A1:2012, Clause 4 applies with the following additions.
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 SYSTEM, 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.
NOTE: a Class I device will not have an (Type B or other) APPLIED PART. Consequently all cross-references to tests or
requirements for APPLIED PARTS in IEC 60601-1 are not applicable for Medical Supply Units.
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ISO/DIS 11197:2024(en)
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 the protrusion hole for the terminal unit of not less than 10 mm.
— 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 SYSTEM 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.
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ISO/DIS 11197:2024(en)
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;
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— 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.
If the medical supply unit has a terminal connecting the neutral line of the power supply, it shall be
clearly 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.
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ISO/DIS 11197:2024(en)
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 document.
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.
201.7.9.2.18 ME EQUIPMENT and ACCESSORIES supplied sterile
This clause does not apply to medical supply units.
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;
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— test of gas identity.
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 60598-1:2020.
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.
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.
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ISO/DIS 11197:2024(en)
If anti-static hoses are used, the electrical resistance of each anti-static hose shall be in accordance with
ISO 5367.
Where hoses are used within medical supply units, a risk analysis shall be made regarding the earthing
of TERMINAL UNITS to prevent electrostatic discharges where installed as part of MEDICAL GAS distribution
systems, a vacuum supply system, an ANAESTHESIA GAS SCAVENGING SYSTEM, a PLUME
EVACUATION SYSTEM or a liquid system.
NOTE 1: If MEDICAL SUPPLY UNITS incorporate hose assemblies, the path to earth can be broken.
NOTE 2: The use of antistatic hose assemblies can make the connection to earth.
Compliance is checked by inspection. Records shall be kept by the manufacturer.
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
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ISO/DIS 11197:2024(en)
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.
Note: Definitions of a Medical Location and the various Group classifications can be found in IEC 60364-
7-710.
Typical examples for potential equalization conductor attachment within 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
to 2,5 mm or AWG 14 of copper and shall be individually connected to the common earth bar.
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
or AWG 6 copper.
be connected to a bus bar with a conductance at least equivalent to that of 16 mm
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.
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ISO/DIS 11197:2024(en)
NOTE
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