Medical supply units (ISO 11197:2019)

This Standard 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.

Medizinische Versorgungseinheiten (ISO 11197:2019)

Diese Besonderen Festlegungen beziehen sich auf solche anwendbaren Ergänzungsnormen, die in IEC 60601-1:2005 + A1:2015, Abschnitt 2 und in Abschnitt 201.2 dieser Besonderen Festlegungen aufgeführt sind.
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 und IEC 60601-1-11 sowie IEC 60601-1-12 gelten nicht.
ANMERKUNG   Ergänzungsnormen werden durch ihre Dokumentennummer referenziert.

Gaines techniques à usage médical (ISO 11197:2019)

Le paragraphe 1.1 de l'IEC 60601-1:2005+A1:2012 est remplacé par:
Le présent document s'applique à la sécurité de base et aux performances essentielles des gaines techniques à usage médical, également désignées sous le terme d'appareil EM.
Le présent document s'applique aux gaines techniques à usage médical fabriquées en usine ou montées sur site, y compris les armoires et autres enveloppes, qui intègrent des services de soins aux patients.
NOTE 1 Une entité qui monte sur site divers composants destinés à des services de soins aux patients pour constituer une enveloppe est considérée comme le fabricant de la gaine technique à usage médical.
Les dangers inhérents à la fonction prévue de l'appareil EM ou des systèmes EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans la présente norme, à l'exception des paragraphes 7.2.13 et 8.4.1 de l'IEC 60601‑1:2005+A1:2012, (voir 201.1.4).
NOTE 2 Voir le paragraphe 4.2 de l'IEC 60601-1:2005+A1:2012.

Enote za oskrbo v medicini (ISO 11197:2019)

Ta standard se uporablja za osnovno varnost in bistvene lastnosti enot za oskrbo v medicini (v nadaljevanju »medicinska električna oprema«). Ta dokument se uporablja za enote za oskrbo v medicini, proizvedene v tovarni ali sestavljene na mestu uporabe, vključno z omaricami in drugimi ohišji, ki zajemajo storitve oskrbe pacientov.

General Information

Status
Published
Public Enquiry End Date
24-May-2018
Publication Date
12-Jan-2020
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
11-Dec-2019
Due Date
15-Feb-2020
Completion Date
13-Jan-2020

RELATIONS

Buy Standard

Standard
SIST EN ISO 11197:2020
English language
44 pages
sale 10% off
Preview
sale 10% off
Preview

e-Library read for
1 day

Standards Content (sample)

SLOVENSKI STANDARD
SIST EN ISO 11197:2020
01-februar-2020
Nadomešča:
SIST EN ISO 11197:2016
Enote za oskrbo v medicini (ISO 11197:2019)
Medical supply units (ISO 11197:2019)
Medizinische Versorgungseinheiten (ISO 11197:2019)
Gaines techniques à usage médical (ISO 11197:2019)
Ta slovenski standard je istoveten z: EN ISO 11197:2019
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN ISO 11197:2020 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 11197:2020
---------------------- Page: 2 ----------------------
SIST EN ISO 11197:2020
EN ISO 11197
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2019
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 11197:2016
English Version
Medical supply units (ISO 11197:2019)

Gaines techniques à usage médical (ISO 11197:2019) Medizinische Versorgungseinheiten (ISO 11197:2019)

This European Standard was approved by CEN on 15 September 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2019 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11197:2019 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 11197:2020
EN ISO 11197:2019 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST EN ISO 11197:2020
EN ISO 11197:2019 (E)
European foreword

This document (EN ISO 11197:2019) has been prepared by Technical Committee ISO/TC 121

"Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215

“Respiratory and anaesthetic equipment” the secretariat of which is held by BSI.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by May 2020, and conflicting national standards shall be

withdrawn at the latest by May 2020.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 11197:2016.

According to the CEN-CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 11197:2019 has been approved by CEN as EN ISO 11197:2019 without any modification.

---------------------- Page: 5 ----------------------
SIST EN ISO 11197:2020
---------------------- Page: 6 ----------------------
SIST EN ISO 11197:2020
INTERNATIONAL ISO
STANDARD 11197
Fourth edition
2019-11
Medical supply units
Gaines techniques à usage médical
Reference number
ISO 11197:2019(E)
ISO 2019
---------------------- Page: 7 ----------------------
SIST EN ISO 11197:2020
ISO 11197:2019(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2019

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2019 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 11197:2020
ISO 11197:2019(E)
Contents Page

Foreword ......................................................................................................................................................................... iv

Introduction ..................................................................................................................................................................... v

201.1 Scope, object and related standards ......................................................................................................... 1

201.1.1 Scope ............................................................................................................................................................ 1

201.1.2 Object ........................................................................................................................................................... 1

201.1.3 Related standards ................................................................................................................................... 1

201.1.3.1 General and Collateral standards ................................................................................................ 1

201.1.3.2 Particular standards ........................................................................................................................ 2

201.2 Normative references .................................................................................................................................... 2

201.3 Terms and definitions .................................................................................................................................... 3

201.4 General requirements .................................................................................................................................... 5

201.5 General requirements for testing ME equipment ................................................................................. 5

201.6 Classification of ME equipment and ME systems ................................................................................... 5

201.7 ME equipment identification, marking and documents ..................................................................... 6

201.8 Protection against electrical hazards from ME equipment ............................................................ 10

201.9 Protection against mechanical hazards of ME equipment and ME systems ............................... 17

201.10 Protection against unwanted and excessive radiation hazards .................................................. 20

201.11 Protection against excessive temperatures and other hazards .................................................. 20

201.12 Accuracy of controls and instruments and protection against hazardous outputs .............. 21

201.13 Hazardous situations and fault conditions .......................................................................................... 21

201.13.2.2 Single fault conditions ................................................................................................................... 21

201.14 Programmable electrical medical systems (PEMS) ........................................................................... 22

201.15 Construction of ME equipment ................................................................................................................. 22

201.16 ME systems ....................................................................................................................................................... 27

201.17 Electromagnetic compatibility of ME equipment and ME systems ................................................ 27

202 Medical electrical equipment — Parts 1-2 General requirements for basic safety and

essential performance — Collateral standard: Electromagnetic disturbances — Requirements

and tests ......................................................................................................................................................................... 27

206 Medical electrical equipment — Parts 1-6 General requirements for basic safety and

essential performance — Collateral standard: Usability............................................................................... 27

Annex A A (informative) Rationale ....................................................................................................................... 28

Annex B B (informative) Tests during production ...................................................................................... 29

Annex C C (informative) Documentation ........................................................................................................ 33

Annex D D (informative) Terminology — Alphabetical index of defined terms .................................. 34

Bibliography ................................................................................................................................................................. 36

© ISO 2019 – All rights reserved
iii
---------------------- Page: 9 ----------------------
SIST EN ISO 11197:2020
ISO 11197:2019(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO

collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any

patent rights identified during the development of the document will be in the Introduction and/or on

the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the World

Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see
www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory

equipment, Subcommittee SC 6, Medical gas supply systems.

This fourth edition cancels and replaces the third edition (ISO 11197:2016), which has been technically

revised. The main changes compared to the previous edition are as follows:
— editorial revision;

— change in the requirements defining the inclusion of USB outlets within medical supply units;

— addition of methods of internal cabling connections and specific tests including but not limited to

impact resistance.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www.iso.org/members.html.
© ISO 2019 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 11197:2020
ISO 11197:2019(E)
Introduction

Many healthcare facilities use surface-mounted or recessed containment systems and enclosures for

accommodating and displaying essential patient care services. These are known as medical supply units.

This document specifies requirements for medical supply units manufactured in factories or assembled

from components on site.

It is intended for use by those persons involved in the design, construction, inspection, testing,

maintenance and operation of healthcare facilities as well as those manufacturing, assembling and

installing medical supply units.

Persons involved in the design, manufacture, installation, maintenance and testing of equipment

intended to be connected to gas for medicinal use, medical device gas, vacuum, anaesthetic gas scavenging

and/or plume extraction systems should be aware of the contents of this document.

This document is a particular standard, based on IEC 60601-1:2005+A1:2012. IEC 60601-

1:2005+A1:2012 is the basic standard for the safety of all medical electrical equipment used by or under

the supervision of qualified personnel in the general medical and patient environment; it also contains

certain requirements for reliable operation to ensure safety.

IEC 60601-1:2005+A1:2012 has associated collateral standards and particular standards. The collateral

standards include requirements for specific technologies and/or hazards and apply to all applicable

equipment, such as medical systems, electromagnetic compatibility (EMC), radiation protection in

diagnostic X-ray equipment, software, etc. The particular standards apply to specific equipment types,

such as medical electron accelerators, high frequency surgical equipment, hospital beds, etc.

NOTE Definitions of collateral standard and particular standard can be found in IEC 60601:2005+A1:2012.

For an explanation of the special numbering in this document and more on the terms “collateral”,

“particular” and “general” standards, see 201.1.3, 201.1.3.1, 201.1.3.2.

Annex AA contains rationale statements for some of the requirements of this document. It is included to

provide additional insight into the reasoning that led to the requirements and recommendations that

have been incorporated in this document. The clauses and subclauses marked with (*) after their number

have a corresponding rationale contained in Annex AA.
In this document, the following print types are used:

— requirements, compliance with which can be verified, and definitions: roman type;

— informative material appearing outside of tables, such as notes, examples and references: in smaller

roman type. Normative text of tables is also in a smaller roman type;
— test methods: italic type;

— terms defined in clause 3 of the general standard, in this document or as noted: italic type.

© ISO 2019 – All rights reserved
---------------------- Page: 11 ----------------------
SIST EN ISO 11197:2020
---------------------- Page: 12 ----------------------
SIST EN ISO 11197:2020
INTERNATIONAL STANDARD ISO 11197:2019(E)
Medical supply units
201.1 Scope, object and related standards
IEC 60601-1:2005+A1:2012, Clause 1 applies except as follows:
201.1.1 Scope
IEC 60601-1:2005+A1:2012, 1.1 is replaced by:

This document applies to the basic safety and essential performance of medical supply units, hereafter also

referred to as ME equipment.

This document applies to medical supply units manufactured within a factory or assembled on site,

including cabinetry and other enclosures, which incorporate patient care services.

NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure

is considered the manufacturer of the medical supply unit.

Hazards inherent in the intended function of ME equipment or ME systems within the scope of this

document are not covered by specific requirements in this standard, except in of IEC 60601-

1:2005+A1:2012, 7.2.13 and 8.4.1 (see 201.1.4).
NOTE 2 Refer to IEC 60601-1:2005+A1:2012, 4.2.
201.1.2 Object
IEC 60601-1:2005+A1:2012, 1.2 is replaced by:

The object of this document is to establish particular basic safety and essential performance requirements

for medical supply units as defined in 201.3.201.
201.1.3 Related standards
201.1.3.1 General and Collateral standards

IEC 60601-1:2005+A1:2012, 1.3 applies as the General Standard with the following addition:

This particular standard refers to those applicable collateral standards that are listed in IEC 60601-

1:2005+A1:2012, Clause 2 as well as 201.2 of this particular standard.
IEC 60601-1-3:2008+A1:2013, IEC 60601-1-8:2006+A1:2012, IEC 60601-1-9:2007,
IEC 60601-1-10:2007+A1:2013 and IEC 60601-1-11 and IEC 60601-1-12 do not apply.
NOTE Collateral standards are referred to by their document numbers.
© ISO 2019 – All rights reserved
---------------------- Page: 13 ----------------------
SIST EN ISO 11197:2020
ISO 11197:2019(E)
201.1.3.2 Particular standards
IEC 60601-1:2005+A1:2012, 1.4 applies with the following additions:

The numbering of sections, clauses and subclauses of this particular standard corresponds to that of

IEC 60601-1:2005+A1:2012 with the prefix “201” (e.g. 201.1 in this standard addresses the content of

IEC 60601-1:2005+A1:2012 Clause 1) or applicable collateral standard with the prefix “20x” where x is

the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard

addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard, 203.4 in this particular

standard addresses the content of Clause 4 of the IEC 60601-1-3 collateral standard, etc.). The changes to

the text of IEC 60601-1:2005+A1:2012 are specified by the use of the following words:

 “Replacement” means that the clause or subclause of IEC 60601-1:2005+A1:2012 or applicable

collateral standard is replaced completely by the text of this particular standard.

 “Addition” means that the text of this particular standard is additional to the requirements of

IEC 60601-1:2005+A1:2012 or applicable collateral standard.

 “Amendment” means that the clause or subclause of IEC 60601-1:2005+A1:2012 or applicable

collateral standard is amended as indicated by the text of this particular standard.

Subclauses or figures which are additional to those of IEC 60601-1:2005+A1:2012 are numbered starting

from 201.101. Additional Annexes are lettered AA, BB, etc., and additional items aa), bb), etc.

Subclauses or figures which are additional to those of a collateral standard are numbered starting from

20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601-1-2, 203 for IEC 60601-1-3,

etc.

The term “this standard” is used to make reference to IEC 60601-1:2005+A1:2012, any applicable

collateral standards and this particular standard taken together.

Where there is no corresponding section, clause or subclause in this particular standard, the section,

clause or subclause of IEC 60601-1:2005+A1:2012 or applicable collateral standard, although possibly

not relevant, applies without modification; where it is intended that any part of

IEC 60601-1:2005+A1:2012 or applicable collateral standard, although possibly relevant, is not to be

applied, a statement to that effect is given in this particular standard.
201.2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

IEC 60364-7-710:2002, Electrical installations of buildings — Part 7-710: Requirements for special

installations or locations - Medical locations
IEC 60598-1:2014+A1:2017 Luminaires — Part 1: General requirements and tests

IEC 60601-1:2005+A1:2012, Medical electrical equipment — Part 1: General requirements for basic safety

and essential performance

IEC 60601-1-2:2014, Medical electrical equipment — Part 1-2: General requirements for basic safety and

essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests

© ISO 2019 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 11197:2020
ISO 11197:2019(E)

IEC 60601-1-3:2008+A1:2013, Medical electrical equipment — Part 1-3: General requirements for basic

safety and essential performance – Collateral standard: Radiation protection in diagnostic X-Ray equipment

IEC 60601-1-6:2010+A1:2013, Medical electrical equipment — Part 1-6: General requirements for basic

safety and essential performance — Collateral standard: Usability

IEC 61386-1:2008+A1:2017, Conduit systems for cable management — Part 1: General requirements

IEC 62684:2018, Interoperability specifications of common external power supply (EPS) for use with data-

enabled mobile telephones
ISO 32, Gas cylinders for medical use - Marking for identification of content

ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels of noise sources

using sound pressure — Engineering methods for an essentially free field over a reflecting plane

ISO 5359:2014, Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with

medical gases

ISO 7396-1:2016, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases

and vacuum

ISO 7396-2:2007, Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems

ISO 9170-1:2017, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with

compressed medical gases and vacuum

ISO 9170-2:2008, Terminal units for medical gas pipeline systems — Part 2: Terminal units for anaesthetic

gas scavenging systems

ISO 14971:2019, Medical devices — Application of risk management to medical devices

ISO 16571:2014, Systems for evacuation of plume generated by medical devices

EN 50174-1:2018, Information technology. Cabling installation — Part 1: Installation specification and

quality assurance

EN 50174-2:2018, Information technology. Cabling installation — Part 2: Installation planning and

practices inside buildings
201.3 Terms and definitions

For the purposes of this document, the terms and definitions given in IEC 60601-1:2005+A1:2012,

ISO 16571:2014, ISO 7396-1:2016 and the following apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/

NOTE An alphabetical index of defined terms is found at the end of this document.

© ISO 2019 – All rights reserved
---------------------- Page: 15 ----------------------
SIST EN ISO 11197:2020
ISO 11197:2019(E)
Replacement of 3.26:
201.3.26
enclosure

surrounding case constructed to provide a degree of protection to personnel against accidental contact

with live parts and also the enclosed equipment against specified environmental conditions

Note 1 to entry: The environmental conditions are referenced in IEC 61950:2007, 3.15.

Note 2 to entry: An enclosure can be subdivided into compartments.
Addition:
201.3.63
medical electrical equipment
ME equipment

Note 1 to entry: medical supply units may be connected to more than one supply mains.

Addition:
201.3.67
multiple socket-outlet

Note 1 to entry: Medical supply units are not considered as a multiple socket outlet.

201.3.201
medical supply unit

permanently installed ME equipment intended to supply electric power, communication means

(telephone, call systems, etc.), data transmission, lighting, and/or gas for medicinal use, medical device gas

and/or liquids, an anaesthetic gas scavenging system and/or a plume evacuation system to medical areas

of a healthcare facility

Note 1 to entry: medical supply units can include ME equipment or ME systems or parts thereof. medical supply units

can also consist of modular sections for electrical supply, lighting for therapy or illumination, communication,

supply of gas for medicinal use, medical device gas and liquids, plume evacuation systems and anaesthetic gas

scavenging systems. Some typical examples of medical supply units are bed head service modules, ceiling pendants,

beams, booms, columns, pillars, wall mounted enclosure for area shut-off valve boxes of the medical gas pipeline

system, joinery, cabinetry, concealed compartments on or in a wall and prefabricated walls.

Note 2 to entry: Examples of configurations are given in Figures 201.103, 201.104 and 201.105.

201.3.202
junction point

connection point(s) between the medical supply unit and the inter-connecting system(s) already installed

201.3.203
compartment

area within an enclosure which is created by separating barriers, walls and covers forming its own cellular

section
© ISO 2019 – All rights reserved
---------------------- Page: 16 ----------------------
SIST EN ISO 11197:2020
ISO 11197:2019(E)
201.4 General requirements
IEC 60601-1:2005+A1:2012, Clause 4 applies.
Addition
201.4.2.3.1 Hazards identified in the IEC 60601 series

The manufacturer shall undertake all tests as defined or referenced within this standard and Annex BB,

and record the results. National standards might also apply which require test and record keeping.

201.5 General requirements for testing ME equipment
IEC 60601-1:2005+A1:2012, Clause 5 applies with the following additions:
201.5.9.2.3 Actuating mechanisms

All external surfaces shall conform to a degree of protection against direct contact in normal use of at least

IP2X or IPXXB. Refer to IEC 60529:1989+AMD1:1999+AMD2:2013 CSV/COR2:2015.

This level of protection to live parts shall not be compromised during maintenance of the medical gas

pipeline systems, anaesthetic gas scavenging systems, plume evacuation systems or liquid pipeline systems,

e.g. by the provision of covers, barriers or individual protection with a degree of protection of at least

IP2X or IPXXB. Refer to IEC 60529:1989+AMD1:1999+AMD2:2013 CSV/COR2:2015.

If requested by the healthcare facility (e.g. in psychiatric or paediatric units or prison healthcare facilities),

the manufacturer shall provide means to prevent inadvertent or unauthorized dismantling of medical

supply units.
201.5.101 Medical supply unit test results

The manufacturer shall test each medical supply unit. The test results shall be recorded and presented to

the responsible organization on request.

The manufacturer shall maintain legible records of all tests undertaken on each medical supply unit

according to applicable requirements subject to a minimum period of 5 years for compliance with this

document.
201.6 Classification of ME equipment and ME systems
IEC 60601-1:2005+A1:2012, Clause 6 applies, with the following additions:
201.6.1 Protection against electric shock
A medical supply unit shall be designed and constructed as class i.
© ISO 2019 – All rights reserved
---------------------- Page: 17 ----------------------
SIST EN ISO 11197:2020
ISO 11197:2019(E)
201.7 ME equipment identification, marking and documents
IEC 60601-1:2005+A1:2012, Clause 7 applies, with the following additions:

201.7.2.1 Minimum requirements for marking on ME equipment and on interchangeable

parts

Mains-operated equipment, including separable components thereof which have a mains part, shall be

provided with permanent and legible marking on the outside of the major part of the equipment

indicating the origin and model or type reference.
201.7.2.1.1 Terminal units

Terminal units for gas for medicinal use and medical device gas which are mounted within a medical supply

unit shall be obvious. Where decorative finishes are applied to the medical supply unit (e.g. graphics,

where the terminal unit is displayed as part of the graphic) the design shall ensure a plain surround to

unit of not less than 10 mm.
the protrusion hole for the terminal

— terminal units for medical gas, medical device gas pipeline systems shall be marked in accordance with

ISO 9170-1:2017. Colour coding, if used, shall be in accordance with ISO 9170-1:2017 and ISO 32.

— terminal units for anaesthetic gas scavenging systems shall be marked in accordance with ISO 9170-

2:2008. Colour coding, if used, shall be in accordance with ISO 9170-2:2008.
— terminal units for liq
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.