ISO/FDIS 11197

• 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
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: ISO/TC 121/SC 6 - Medical gas supply systems
• Drafting Committee: ISO/TC 121/SC 6 - Medical gas supply systems
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 23-Jul-2026
• Completion Date: 23-Jul-2026

• Consolidates: FprEN ISO 11197 - Medical supply units (ISO/FDIS 11197:2026)
• Effective Date: 12-Feb-2026
• Revises: ISO 11197:2019 - Medical supply units
• Effective Date: 23-Jul-2022

Overview

ISO/FDIS 11197:2026 – Medical Supply Units specifies requirements for the basic safety and essential performance of medical supply units (MSUs) in healthcare environments. Medical supply units are integral parts of healthcare facilities, providing services such as electrical power, communication connections, lighting, medical gases, and liquids at the point of care. This standard applies to MSUs both factory manufactured and those assembled on site, including cabinetry, joinery, and enclosures that form part of patient care services.

Developed by ISO Technical Committee 121/SC 6, this standard replaces previous editions to reflect technological advancements and the evolution of healthcare facility needs-including requirements for both temporary and permanent healthcare installations. It covers MSUs used in all clinical environments and addresses the marking, performance, and testing to ensure the optimal safety and functionality of these critical devices.

Key Topics

ISO/FDIS 11197 provides comprehensive requirements and guidelines for the following key areas:

• Basic Safety and Essential Performance: Outlines general and particular requirements for MSU safety, drawing on the foundational IEC 60601-1 medical electrical equipment standard.
• Design, Manufacturing, and Assembly: Applies to MSUs whether built in manufacturing facilities or assembled at healthcare premises. Defines the manufacturer’s responsibilities, including on-site assembly.
• Electrical and Gas Services Integration: Specifies requirements for electrical power outlets, communication systems, light fixtures, as well as integration of medical gases, vacuum, and even plume evacuation systems.
• Protection against Hazards: Contains measures to reduce risks associated with electrical, mechanical, temperature-related, radiation, and other hazards.
• Identification and Marking: Requires clear marking of all MSU components, connectors, terminal units, and attachable parts, with specific labelling for different services (e.g., medical gas, power outlets, liquids).
• Testing and Documentation: Mandates rigorous testing procedures and traceable documentation to demonstrate compliance with safety and performance requirements.

Applications

Medical Supply Units (MSUs) designed under ISO/FDIS 11197 are critical for a wide variety of clinical settings, supporting clinical workflows and patient safety. Practical applications include:

• Hospital Bed Areas: Bedhead service modules and wall supply units delivering power, gas, data, and communication at patient bedsides.
• Operating Theatres and ICUs: Ceiling pendants, columns, beams, or booms that allow flexible and safe distribution of services to critical care environments.
• Emergency and Temporary Facilities: Rapid installation or conversion for pandemic, disaster response, or surge capacity, while maintaining compliance with safety requirements.
• Special Environments: Custom solutions for mental health, paediatric, or correctional facilities where additional safety considerations-such as anti-ligature designs-are needed.
• Ancillary Areas: Integration of terminal units for medical gas, vacuum, lighting, and communication in diagnostic and treatment zones.

By specifying robust safety and performance standards, ISO/FDIS 11197 supports facility designers, manufacturers, care providers, and regulatory authorities in ensuring reliable operation and risk mitigation for patient-facing systems.

Related Standards

ISO/FDIS 11197 references and aligns with numerous international standards to provide comprehensive and interoperable criteria for MSUs, including but not limited to:

• IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment.
• ISO 7396-1 / ISO 7396-2: Standards for medical gas pipeline systems.
• ISO 9170-1 / ISO 9170-2: Terminal units for medical gas and anaesthetic scavenging systems.
• ISO 14971: Application of risk management to medical devices.
• IEC 60529: Degrees of protection provided by enclosures (IP code).
• ISO 5359 / ISO 5367: Anaesthetic and respiratory equipment standards.
• IEC 62684: Power supply interoperability for mobile devices.
• EN 50174: IT cabling installation specifications.
• IEC 60601-1-2 / IEC 60601-1-6: Collateral standards for EMC and usability.

Adhering to ISO/FDIS 11197 ensures that medical supply units meet international expectations for safety, reliability, and interoperability in modern healthcare settings.

FINAL DRAFT
International
Standard
ISO/TC 121/SC 6
Medical supply units
Secretariat: ANSI
Gaines techniques à usage médical
Voting begins on:
2026-07-23
Voting terminates on:
2026-09-17
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 SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
FINAL DRAFT
International
Standard
ISO/TC 121/SC 6
Medical supply units
Secretariat: ANSI
Gaines techniques à usage médical
Voting begins on:
Voting terminates on:
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 SUPPOR TING DOCUMENTATION.
© ISO 2026
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/CEN PARALLEL PROCESSING
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
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ii
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 General requirements . 3
4.1 General .3
4.2 Hazards identified in the IEC 60601 series .3
5 General requirements for testing ME equipment . 3
5.1 General .3
5.2 Actuating mechanisms .3
5.3 Medical supply unit test results . .3
6 Classification of ME equipment and ME systems. 4
6.1 General .4
6.2 Protection against electric shock .4
7 ME equipment identification, marking and documents . 4
7.1 General .4
7.2 Minimum requirements for marking on ME equipment and on interchangeable parts .4
7.3 Terminal units .4
7.4 Minimum requirements for marking on medical supply units and attachable parts .5
7.5 Connection to the supply mains .5
7.6 Output connectors .5
7.6.1 Mains power output.5
7.6.2 USB Charging .5
7.7 Functional earth terminals .6
7.8 Replacements .6
7.8.1 Marking on the inside of ME equipment or ME equipment parts .6
7.8.2 Colours of indicator lights .6
7.9 Accompanying documents .6
7.9.1 General .6
7.9.2 Instructions for use and maintenance .7
7.9.3 Technical description .7
8 Protection against electrical hazards from ME equipment . 8
8.1 General .8
8.2 Fundamental rule of protection against electric shock .8
8.3 Protection earthing, functional earthing and potential equalization of ME equipment .8
8.4 Protective earth terminal .8
8.5 Potential equalization conductor .9
8.6 Conductors .10
8.7 Bus bar .10
8.8 Components and wiring – Insulation of internal wiring .11
8.9 Mains parts, components and layout .14
8.9.1 Isolation from the supply mains .14
8.9.2 Multiple socket-outlets . 15
8.9.3 Power supply cords . 15
8.10 Layout . 15
9 Protection against mechanical hazards of ME equipment and ME systems.15
9.1 General . 15
9.2 Dynamic forces . 15
9.3 Impact resistance test . 15
9.4 Static forces .16

iii
9.5 Static load test .16
9.6 Mechanical damage .16
9.7 Acoustic energy (including infra- and ultrasound) and vibration – Frequency spectrum .17
9.8 Mechanical hazards associated with support systems – Tensile safety factors .18
10 Protection against unwanted and excessive radiation hazards .18
11 Protection against excessive temperatures and other hazards .18
11.1 General .18
11.2 Excessive temperatures in ME equipment – Temperatures of luminaires .18
11.3 Fire prevention .18
11.4 ME equipment and ME systems used in conjunction with oxygen-rich environments –
Venting .18
11.4.1 General .18
11.4.2 Test outcomes.18
11.4.3 Example test method .19
11.5 Sterilization of ME equipment and ME systems .19
12 Accuracy of controls and instruments and protection against hazardous outputs . 19
13 Hazardous situations and fault conditions . 19
13.1 General .19
13.2 Single fault conditions .19
13.2.1 General .19
13.2.2 Single fault conditions .19
14 Programmable electrical medical systems (PEMS) . 19
15 Construction of ME equipment .20
15.1 General . 20
15.2 Arrangements of controls and indicators of ME equipment . 20
15.3 Drop test . 20
15.4 ME equipment components and general assembly . 20
15.4.1 Potential equalization connectors . 20
15.4.2 Batteries . 20
15.4.3 Excessive current and voltage protection . 20
15.5 Terminal unit construction . 23
16 ME systems .24
17 Electromagnetic compatibility of ME equipment and ME systems .24
18 Medical electrical equipment —General requirements for basic safety and essential
performance —Electromagnetic disturbances — Requirements and tests .24
19 Medical electrical equipment —General requirements for basic safety and essential
performance — Usability .24
20 Annexes .25
Annex A (informative) Rationale .26
Annex B (informative) Tests during production .27
Annex C (informative) Documentation .30
Annex D (informative) Terminology — Alphabetical index of defined terms .31
Annex ZA (informative) Relationship between this European standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .33
Bibliography .38

iv
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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, in collaboration with the European Committee for
Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This fifth edition cancels and replaces the fourth edition (ISO 11197:2019), which has been technically
revised.
The main changes are as follows:
— 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+A2:2020
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.

v
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+A2:2020.
IEC 60601-1:2005+A1:2012 +A2:2020 is the general 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+A2:2020 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 document shall apply. Once the stage of critical use of the facility has normalised
the product remaining in use shall fulfil the requirements of this document.
NOTE Definitions of collateral standard and particular standard can be found in IEC 60601:2005+A1:2012+A2:2020.
Annex A 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.

vi
FINAL DRAFT International Standard ISO/FDIS 11197:2026(en)
Medical supply units
1 Scope
This document establishes particular basic safety and essential performance requirements for medical supply
units as defined in 3.2.
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 document, except in IEC 60601-1:2005+A1: 2012+ A2: 2020,
7.2.13 and 8.4.1 (see Clause 4).
NOTE 2 Refer to IEC 60601-1:2005+A1: 2012+ A2: 2020, 4.2.
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.
ISO 32, Gas cylinders for medical use — Marking for identification of content
ISO 3744:2025, Acoustics — Determination of sound power 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 16571:2024, Systems for evacuation of plume generated by medical devices
IEC 60364-7-710:2021, Electrical installations of buildings — Part 7-710: Requirements for special installations
or locations - Medical locations

IEC 60598-1:2024, Luminaires — Part 1: General requirements and tests
IEC 60601-1:2005+A1: 2012+ A2: 2020, Medical electrical equipment — Part 1: General requirements for basic
safety and essential performance
IEC 60601-1-2:2014+A1: 2020, Medical electrical equipment — Part 1-2: General requirements for basic safety
and essential performance — Collateral standard: Electromagnetic disturbances — Requirements and tests
IEC 60601-1-3:2008+A1: 2013+ A2: 2021, 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+ A2: 2020, 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
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
3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005+A1: 2012+ A2: 2020,
ISO 16571:2024, ISO 7396-1:2016 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
NOTE An alphabetical index of defined terms is provided in Annex D.
3.1
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.
3.2
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 3, 4 and 5.

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.
3.3
junction point
connection point(s) between the medical supply unit and the inter-connecting system(s) already installed
3.4
compartment
area within an enclosure which is created by separating barriers, walls and covers forming its own cellular
section
4 General requirements
4.1 General
IEC 60601-1:2005+A1: 2012+ A2: 2020, Clause 4 applies, with the following addition.
4.2 Hazards identified in the IEC 60601 series
The manufacturer shall undertake all tests as defined or referenced within this document and Annex B and
record the results.
NOTE National standards can also apply which require test and record keeping.
5 General requirements for testing ME equipment
5.1 General
IEC 60601-1:2005+A1: 2012+ A2: 2020, Clause 5 applies with the following additions.
5.2 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.
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.
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.
5.3 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 conformance with this document.

6 Classification of ME equipment and ME systems
6.1 General
IEC 60601-1:2005+A1: 2012+ A2: 2020, Clause 6 applies, with the following additions.
6.2 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.
7 ME equipment identification, marking and documents
7.1 General
IEC 60601-1:2005+A1: 2012+ A2: 2020, Clause 7 applies, with the following additions.
7.2 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.
7.3 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 1 or with the equivalent national language.
— terminal units for plume evacuation shall be marked in accordance with ISO 16571:2024.
NOTE Regional or national regulations which apply to ME equipment identification, marking and documents can
exist.
Table 1 — Marking for liquids
Name of liquid
Potable water, cold
Potable water, warm
Cooling water
Cooling water, feed-back
De-mineralized water
TTabablele 1 1 ((ccoonnttiinnueuedd))
Name of liquid
Distilled water
Dialysing concentrate
Dialysing permeate
7.4 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.
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.
7.5 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.
7.6 Output connectors
7.6.1 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 60364-7-710:2021),
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.
7.6.2 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;
— rated output voltage;
— Medical Use Only.
7.7 Functional earth terminals
Facilities for the connection of protective equipotential bonding shall be marked with symbol 8 of
IEC 60601-1:2005+A1: 2012+ A2: 2020, Annex D, Table D.
7.8 Replacements
7.8.1 Marking on the inside of ME equipment or ME equipment parts
IEC 60601-1:2005+A1: 2012+ A2: 2020, 7.3 is replaced by the following:
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 1 or the equivalent in national language.
Junction points and pipelines for plume evacuation shall be marked in accordance with ISO 16571:2024.
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+ A2: 2020, Annex D.3, the letter N and/or be colour
coded blue.
7.8.2 Colours of indicator lights
IEC 60601-1:2005+A1: 2012+ A2: 2020, 7.8.1 is replaced by the following:
Where electrical components such as indicators, control buttons and the like are incorporated into a medical
supply unit, the requirements of IEC 60601-1:2005+A1: 2012+ A2: 2020 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 IEC 60601-1:2005+A1: 2012+ A2: 2020.
NOTE 2 The illumination of an indicator might not truly reflect the operational state of the socket-outlet or its
supply mains.
7.9 Accompanying documents
7.9.1 General
Replace the first dash in IEC 60601-1:2005+A1: 2012+ A2: 2020, 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 conformance with this
document and that the manufacturer has satisfied the testing requirements.
7.9.2 Instructions for use and maintenance
7.9.2.1 General
The instructions for use shall contain the date of issue or the latest revision of the document.
7.9.2.2 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 document 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 conformance with this document
and supported by the manufacturer’s instructions.
NOTE Refer to IEC 60364-7-710:2021 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.
7.9.2.3 ME equipment and accessories supplied sterile
IEC 60601-1:2005+A1: 2012+ A2: 2020, 7.9.2.3 does not apply to medical supply units.
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
...

ISO TC 121/SC 6
Date: 2026-04-22
ISO /FDIS 11197:2026(E)
ISO/TC 121/SC 6
Secretariat:  ANSI
Date: 2026-07-08
Medical supply units
Gaines techniques à usage médical
TThhiis s drdraafftt i is s susubbmmiitttteed d ttoo aa ppaarraallellel l vvoottee i inn IISSOO,, CCEEN.N.

Copyright notice
ThisFDIS stage
© ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted under 2026
All rights reserved. Unless otherwise specified, or required in the applicable lawscontext of the user's country, neither
its implementation, no part of this ISO draft nor any extract from itpublication may be reproduced, stored in a retrieval
system or transmitted or utilized otherwise in any form or by any means, electronic, or mechanical, including
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Requests for permission to reproduce should be addressed to . Permission can be requested from either ISO at the
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Published in Switzerland
iii
Contents Page
Foreword . vii
Introduction . ix
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 3
4 General requirements . 4
4.1 General . 4
4.2 Hazards identified in the IEC 60601 series . 4
5 General requirements for testing ME equipment . 4
5.1 General . 4
5.2 Actuating mechanisms . 4
5.3 Medical supply unit test results . 4
6 Classification of ME equipment and ME systems . 5
6.1 General . 5
6.2 Protection against electric shock . 5
7 ME equipment identification, marking and documents . 5
7.1 General . 5
7.2 Minimum requirements for marking on ME equipment and on interchangeable parts . 5
7.3 Terminal units . 5
7.4 Minimum requirements for marking on medical supply units and attachable parts . 6
7.5 Connection to the supply mains . 6
7.6 Output connectors . 6
7.7 Functional earth terminals . 7
7.8 Replacements . 7
7.9 Accompanying documents . 8
8 Protection against electrical hazards from ME equipment . 10
8.1 General . 10
8.2 Fundamental rule of protection against electric shock . 10
8.3 Protection earthing, functional earthing and potential equalization of ME equipment . 10
8.4 Protective earth terminal . 10
8.5 Potential equalization conductor . 13
8.6 Conductors . 13
8.7 Bus bar . 13
8.8 Components and wiring – Insulation of internal wiring . 15
8.9 Mains parts, components and layout . 22
8.10 Layout . 23
9 Protection against mechanical hazards of ME equipment and ME systems . 23
9.1 General . 23
9.2 Dynamic forces . 23
9.3 Impact resistance test . 23
9.4 Static forces . 24
9.5 Static load test . 24
9.6 Mechanical damage . 24
9.7 Acoustic energy (including infra- and ultrasound) and vibration – Frequency spectrum . 27
9.8 Mechanical hazards associated with support systems – Tensile safety factors . 27
10 Protection against unwanted and excessive radiation hazards . 27
iv
11 Protection against excessive temperatures and other hazards . 27
11.1 General . 27
11.2 Excessive temperatures in ME equipment – Temperatures of luminaires . 27
11.3 Fire prevention . 27
11.4 ME equipment and ME systems used in conjunction with oxygen-rich environments –
Venting . 28
11.5 Sterilization of ME equipment and ME systems . 28
12 Accuracy of controls and instruments and protection against hazardous outputs . 28
13 Hazardous situations and fault conditions . 28
13.1 General . 28
13.2 Single fault conditions . 29
14 Programmable electrical medical systems (PEMS) . 29
15 Construction of ME equipment . 29
15.1 General . 29
15.2 Arrangements of controls and indicators of ME equipment . 30
15.3 Drop test . 30
15.4 ME equipment components and general assembly . 30
15.5 Terminal unit construction . 34
16 ME systems . 35
17 Electromagnetic compatibility of ME equipment and ME systems . 35
18 Medical electrical equipment —General requirements for basic safety and essential
performance —Electromagnetic disturbances — Requirements and tests . 35
19 Medical electrical equipment —General requirements for basic safety and essential
performance — Usability . 35
20 Annexes . 35
Annex A (informative) Rationale . 36
Annex B (informative) Tests during production . 37
Annex C (informative) Documentation . 42
Annex D (informative) Terminology — Alphabetical index of defined terms . 43
Annex ZA (informative) Relationship between this European standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 44
Bibliography . 51

Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 2
3 Terms and definitions . 3
4 General requirements . 5
5 General requirements for testing ME equipment . 5
6 Classification of ME equipment and ME systems . 5
7 ME equipment identification, marking and documents . 6
v
8 Protection against electrical hazards from ME equipment . 10
9 Protection against mechanical hazards of ME equipment and ME systems . 17
10 Protection against unwanted and excessive radiation hazards . 20
11 Protection against excessive temperatures and other hazards . 20
12 Accuracy of controls and instruments and protection against hazardous outputs . 21
13 Hazardous situations and fault conditions . 21
14 Programmable electrical medical systems (PEMS) . 22
15 Construction of ME equipment . 22
16 ME systems . 27
17 Electromagnetic compatibility of ME equipment and ME systems . 27
18 Medical electrical equipment — General requirements for basic safety and essential
performance — Collateral standard: Electromagnetic disturbances — Requirements and
tests . 27
19 Medical electrical equipment — General requirements for basic safety and essential
performance — Collateral standard: Usability . 27
20 Annexes . 27
Annex A (informative)  Rationale . 28
Annex B (informative)  Tests during production . 29
Annex C (informative)  Documentation . 33
Annex D (informative)  Terminology — Alphabetical index of defined terms . 34
Bibliography . 36
vi
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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent rights
in respect thereof. As of the date of publication of this document, ISO had not received notice of (a) patent(s)
which may be required to implement this document. However, implementers are cautioned that this may not
represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents.www.iso.org/patents. ISO shall not be held responsible for identifying any or all such
patent rights.
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.htmlwww.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, in collaboration with the European Committee for
Standardization (CEN) Technical Committee CEN/TC 215, Respiratory and anaesthetic equipment, in
accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This fifth edition cancels and replaces the fourth edition (ISO 11197:2019), which has been technically
revised.
The main changes are as follows:
— — 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+A2:2020
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.htmlwww.iso.org/members.html.
vii
viii
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+A2:2020. IEC 60601-
1:2005+A1:2012 +A2:2020 is the general 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+A2:2020 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 document shall apply. Once the stage of critical use of the facility has normalised
the product remaining in use shall fulfil the requirements of this document.
NOTE Definitions of collateral standard and particular standard can be found in
IEC 60601:2005+A1:2012+A2:2020.
Annex AAnnex A 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.
ix
FINAL DRAFT International Standard ISO/FDIS 11197:2026(en)

Medical supply units
1 1 Scope
This document establishes particular basic safety and essential performance requirements for medical supply
units as defined in 3.2.
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 document, except in IEC 60601-1:2005+A1:2012+A2:2020,
7.2.13 and 8.4.1 (see Clause 4).Clause 4).
NOTE 2 Refer to IEC 60601-1:2005+A1:2012+A2:2020, 4.2.
The object of this document is to establish particular basic safety and essential performance requirements for
medical supply units as defined in 3.2.
2 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.
ISO 32, Gas cylinders for medical use — Marking for identification of content
ISO 3744:2025, Acoustics — Determination of sound power 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 AWI /FDIS 11197:2023(E)
N1112026(en)
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 16571:2024, Systems for evacuation of plume generated by medical devices
IEC 60364-7-710:20022021, Electrical installations of buildings — Part 7-710: Requirements for special
installations or locations - Medical locations
IEC 60598-1:2014+A1:20172024, Luminaires — Part 1: General requirements and tests
IEC 60601-1:2005+A1:2012+A2:2020, Medical electrical equipment — Part 1: General requirements for basic
safety and essential performance
IEC 60601-1-2:2014+A1:2020, Medical electrical equipment — Part 1-2: General requirements for basic safety
and essential performance –— Collateral standard: Electromagnetic disturbances –— Requirements and tests
IEC 60601-1-3:2008+A1:2013+A2:2021, 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+A2:2020, 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
3 3 Terms and definitions
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005+A1:2012+A2:2020,
ISO 16571:20142024, ISO 7396-1:2016 and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— — ISO Online browsing platform: available at https://www.iso.org/obphttps://www.iso.org/obp
— — IEC Electropedia: available at http://www.electropedia.org/https://www.electropedia.org/
NOTE An alphabetical index of defined terms is provided in Annex D.Annex D.
3.1 3.1
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.
3.2 3.2
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 3, 4Figures 3, 4 and 5.5.
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.
© ISO 2026 – All rights reserved
ISO AWI /FDIS 11197:2023(E)
N1112026(en)
3.3 3.3
junction point
connection point(s) between the medical supply unit and the inter-connecting system(s) already installed
3.4 3.4
compartment
area within an enclosure which is created by separating barriers, walls and covers forming its own cellular
section
4 4 General requirements
4.1 4.1 General
IEC 60601-1:2005+A1:2012+A2:2020, Clause 4 applies, with the following addition.
4.2 4.2 Hazards identified in the IEC 60601 series
The manufacturer shall undertake all tests as defined or referenced within this document and
Annex B,Annex B and record the results.
NOTE National standards can also apply which require test and record keeping.
5 5 General requirements for testing ME equipment
5.1 5.1 General
IEC 60601-1:2005+A1:2012+A2:2020, Clause 5 applies with the following additions.
5.2 5.2 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.
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.
5.3 5.3 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 conformance with this document.
6 6 Classification of ME equipment and ME systems
6.1 6.1 General
IEC 60601-1:2005+A1:2012+A2:2020, Clause 6 applies, with the following additions.
6.2 6.2 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.
7 7 ME equipment identification, marking and documents
7.1 7.1 General
IEC 60601-1:2005+A1:2012+A2:2020, Clause 7 applies, with the following additions.
7.2 7.2 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.
7.3 7.3 Terminal units
terminalTerminal 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 1Table 1 or with the equivalent national language.
— — terminal units for plume evacuation shall be marked in accordance with ISO 16571:20142024.
NOTE Regional or national regulations which apply to ME equipment identification, marking and documents can
exist.
Table 1 — Marking for liquids
Name of liquid
Potable water, cold
Potable water, warm
Cooling water
Cooling water, feed-back
© ISO 2026 – All rights reserved
ISO AWI /FDIS 11197:2023(E)
N1112026(en)
Name of liquid
De-mineralized water
Distilled water
Dialysing concentrate
Dialysing permeate
7.4 7.4 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.
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.
7.5 7.5 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.
7.6 7.6 Output connectors
7.6.1 7.6.1 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--
710:20022021), 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.
7.6.2 7.6.2 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;
— — rated output voltage;
— — Medical Use Only.
7.7 7.7 Functional earth terminals
Facilities for the connection of protective equipotential bonding shall be marked with symbol 8 of IEC 60601-
1:2005+A1:2012+A2:2020, Annex D, Table D.
7.8 7.8 Replacements
7.8.1 7.8.1 Marking on the inside of ME equipment or ME equipment parts
IEC 60601-1:2005+A1:2012+A2:2020, 7.3 is replaced by the following:
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 1Table 1 or the equivalent in national language.
Junction points and pipelines for plume evacuation shall be marked in accordance with ISO 16571:20142024.
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+A2:2020, Annex D.3, the letter N and/or be colour
coded blue.
7.8.2 7.8.2 Colours of indicator lights
IEC 60601-1:2005+A1:2012+A2:2020, 7.8.1 is replaced by the following:
Where electrical components such as indicators, control buttons and the like are incorporated into a medical
supply unit, the requirements of IEC 60 601 60601-1:2005+A1:2012+A2:2020 shall be maintained.
© ISO 2026 – All rights reserved
ISO AWI /FDIS 11197:2023(E)
N1112026(en)
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 IEC 60601-1:2005+A1:2012. +A2:2020.
NOTE 2 The illumination of an indicator might not truly reflect the operational state of the socket-outlet or its supply
mains.
7.9 7.9 Accompanying documents
7.9.1 7.9.1 General
Replace the first dash in IEC 60601-1:2005+A1:2012+A2:2020, 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 conformance with this
document and that the manufacturer has satisfied the testing requirements.
7.9.2 7.9.2 Instructions for use and maintenance
7.9.2.1 7.9.2.1 General
The instructions for use shall contain the date of issue or the latest revision of the document.
7.9.2.2 7.9.2.2 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 document 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 conformance with this document
and supported by the manufacturer’s instructions.
NOTE Refer to IEC 60364-7-710:20022021 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.
7.9.2.3 7.9.2.3 ME equipment and accessories supplied sterile
IEC 60601-1:2005+A1:2012+A2:2020, 7.9.2.3 does not apply to medical supply units.
7.9.3 7.9.3 Technical description
a) 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:
1) test for leakage;
2) test for obstruction;
3) test for particulate contamination;
4) test of flow and pressure drop;
5) test for cross connection;
6) test of gas identity.
b) 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
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