Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment

This document is applicable to the basic safety and essential performance of oxygen conserving equipment, hereafter referred to as ME equipment, in combination with its accessories intended to conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is typically used by a lay operator.
NOTE 1 Conserving equipment can also be used in professional health care facilities.
This document is also applicable to conserving equipment that is incorporated with other equipment.
EXAMPLE Conserving equipment combined with a pressure regulator[2], an oxygen concentrator[7] or liquid oxygen equipment[4].
This document is also applicable to those accessories intended by their manufacturer to be connected to conserving equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the conserving equipment.
This document is intended to clarify the difference in operation of various conserving equipment models, as well as between the operation of conserving equipment and continuous flow oxygen equipment, by requiring standardized performance testing and labelling.
This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is not applicable to non-active devices (e.g. reservoir cannulas).
If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.
Hazards inherent in the intended physiological 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+AMD1:2012, 7.2.13 and 8.4.1.
NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.

Appareils électromédicaux - Partie 2-67: Exigences particulières pour la sécurité de base et les performances essentielles des économiseurs d'oxygène

Le présent document s'applique à la sécurité de base et aux performances essentielles d'un économiseur d'oxygène, désigné ci-après sous le terme d'appareil EM, ainsi que de ses accessoires prévus pour économiser le supplément d'oxygène en délivrant du gaz de manière intermittente et synchronisée en suivant le cycle d'inspiration du patient, pour une utilisation dans l'environnement de soins à domicile. L'économiseur d'oxygène est habituellement utilisé par un opérateur non spécialiste.
NOTE 1 Un économiseur peut également être utilisé dans des établissements de santé.
Le présent document s'applique également aux économiseurs intégrés à d'autres appareils.
EXEMPLE Économiseur associé à un détendeur[2], un concentrateur d'oxygène[7] ou un appareil à oxygène liquide[4].
Le présent document s'applique également aux accessoires destinés par leur fabricant à être raccordés à un économiseur, du fait que les caractéristiques de ces accessoires peuvent avoir un impact sur la sécurité de base ou sur les performances essentielles de l'économiseur.
Le présent document vise à préciser les différences de fonctionnement entre différents modèles d'économiseurs, ainsi que les différences de fonctionnement entre économiseurs et appareils à oxygène à débit continu, en exigeant des essais de performance et un étiquetage normalisés.
Le présent document ne s'applique qu'aux dispositifs actifs (par exemple, dotés d'une alimentation pneumatique ou électrique) et ne s'applique pas aux dispositifs non actifs (par exemple, canules de réservoir).
Si un article ou un paragraphe est spécifiquement destiné à être appliqué uniquement aux appareils EM ou uniquement aux systèmes EM, le titre et le contenu dudit article ou paragraphe l'indiqueront. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux appareils EM et aux systèmes EM, selon le cas.
Les dangers inhérents à la fonction physiologique prévue des appareils 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 le présent document, à l'exception de l'IEC 60601‑1:2005+AMD1:2012, 7.2.13 et 8.4.1.
NOTE 2 Des informations supplémentaires peuvent être trouvées dans l'IEC 60601‑1:2005+AMD1:2012, 4.2.

General Information

Status
Published
Publication Date
29-Oct-2020
Current Stage
PPUB - Publication issued
Completion Date
02-Nov-2020
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INTERNATIONAL ISO
STANDARD 80601-2-67
Second edition
2020-10
Medical electrical equipment —
Part 2-67:
Particular requirements for basic
safety and essential performance of
oxygen-conserving equipment
Appareils électromédicaux —
Partie 2-67: Exigences particulières pour la sécurité de base et les
performances essentielles des économiseurs d'oxygène
Reference number
ISO 80601-2-67:2020(E)
ISO 2020
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ISO 80601-2-67:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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ISO 80601-2-67:2020(E)
Contents Page

Foreword ........................................................................................................................................................................... v

Introduction ................................................................................................................................................................... vi

201. 1 * Scope, object and related standards ...................................................................................................... 1

201. 2 Normative references .................................................................................................................................... 3

201. 3 Terms and definitions .................................................................................................................................... 4

201. 4 General requirements .................................................................................................................................... 5

201. 5 General requirements for testing of ME equipment ............................................................................ 7

201. 6 Classification of ME equipment and ME systems ................................................................................... 8

201. 7 * ME equipment identification, marking and documents .................................................................. 8

201. 8 Protection against electrical hazards from ME equipment ............................................................ 15

201. 9 Protection against mechanical hazards of ME equipment and ME systems .............................. 15

201. 10 Protection against unwanted and excessive radiation hazards .................................... 16

201. 11 Protection against excessive temperatures and other hazards .................................... 16

201. 12 Accuracy of controls and instruments and protection against hazardous

outputs .............................................................................................................................................................. 18

201. 13 Hazardous situations and fault conditions ............................................................................ 21

201. 14 Programmable electrical medical systems (PEMS) ............................................................. 21

201. 15 Construction of ME equipment ................................................................................................... 22

201. 16 ME systems ........................................................................................................................................ 22

201. 17 Electromagnetic compatibility of ME equipment and ME systems ................................ 22

201.101 Gas connections.......................................................................................................................................... 22

201.102 Requirements for parts and accessories ........................................................................................... 23

201.103 Oxygen pressure regulators .................................................................................................................. 25

202 Electromagnetic disturbances – Requirements and tests .............................................................. 25

202.4.3.1 * Configurations .............................................................................................................................. 25

206 Usability ........................................................................................................................................................... 26

Annex C (informative) Guide to marking and labelling requirements for ME equipment and

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

Annex D (informative) Symbols on marking ................................................................................................... 32

Annex AA (informative) Particular guidance and rationale ...................................................................... 33

Annex BB (informative) Reference to the IMDRF essential principles and labelling

guidances ......................................................................................................................................................... 42

Annex CC (informative) Reference to the essential principles ................................................................... 46

Annex DD (informative) Reference to the general safety and performance requirements ........... 49

© ISO 2020 – All rights reserved iii
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ISO 80601-2-67:2020(E)

Annex EE (informative) Terminology — Alphabetized index of defined terms ................................. 53

Bibliography ................................................................................................................................................................. 56

iv © ISO 2020 – All rights reserved
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ISO 80601-2-67:2020(E)
Foreword

ISO (the International Organization for Standardization) and IEC (the International Electrotechnical

Commission) form the specialized system for worldwide standardization. National bodies that are

members of ISO or IEC participate in the development of International Standards through technical

committees established by the respective organization to deal with particular fields of technical activity.

ISO and IEC technical committees collaborate in fields of mutual interest. Other international

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

work.

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 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).

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

patent rights. ISO and IEC 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) or the

IEC list of patent declarations received (see http://patents.iec.ch).

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 jointly by Technical Committee ISO/TC 121, Anaesthetic and respiratory

equipment, Subcommittee SC 3, Respiratory devices and related equipment used for patient care, and

Technical Committee IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC D,

Electromedical equipment, 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 second edition cancels and replaces the first edition (ISO 80601-2-67:2014), which has been

technically revised.
The main changes compared to the previous edition are as follows:
— clarified the accessibility of inlet and outlet connectors;
— formatted to provide a unique identifier for each requirement; and
— harmonization with the ‘A2 project’ of the general standard.

A list of all parts in the ISO and IEC 80601 series can be found on the ISO and IEC websites.

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 2020 – All rights reserved v
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ISO 80601-2-67:2020(E)
Introduction

Long-term oxygen therapy has been demonstrated in randomized, controlled clinical trials to prolong

survival in patients with chronic respiratory disease and documented hypoxemia. Typical sources of

therapeutic long-term oxygen therapy include gaseous oxygen from cylinders or from liquid oxygen and

oxygen from an oxygen concentrator.

Most clinicians prescribe low flow oxygen therapy as continuous flow oxygen (CFO) delivery in l/min.

CFO systems deliver the flow of oxygen without regard for the patient’s breathing rate or pattern.

Outside of the institutional care setting, the provision of CFO therapy is often a significant expense and

can limit the mobility of a patient to the immediate vicinity of a stationary or fixed oxygen delivery

system. To support mobility, patients use CFO from portable liquid or compressed oxygen systems with

a limited storage capacity that can limit a patient’s time and activities while away from a stationary

oxygen supply.

Conserving equipment that delivers supplemental oxygen as a bolus conserves usage while allowing

satisfactory patient arterial oxygen saturation (SaO ) to be maintained during daily activities.

Conserving equipment delivers supplemental oxygen unlike CFO in that the therapy gas flow is delivered

only during the inspiratory phase of the breathing cycle, when it is most likely to reach the alveoli.

During both the expiratory and pause phase of the breathing cycle, the flow of supplemental oxygen is

stopped, minimizing waste. Because flow over time produces a volume, the bolus delivered by the

conserving equipment is typically represented as a volume of gas. Therapy using conserving equipment

versus CFO results in lower operating costs and longer ambulatory times for patients using the same

CFO storage capacity.

Operation of conserving equipment from various manufacturers might differ in the dose delivery

mechanism resulting in variations in oxygen therapy to the patient. The use of CFO numerical markings

for dose settings on conserving equipment might not directly correlate with CFO settings and might lead

to misinterpretation of gas delivery rates and volumes for a particular patient. This might result in

incorrect patient setup and therapy delivery over all breathing rates and patterns versus CFO. Because

of the differences in delivery, settings, and markings versus CFO therapy, conserving equipment use has

requirements for patient titration to determine the proper setting(s) needed to provide adequate SaO

levels for the patient breathing patterns.
In this document, the following print types are used:
— requirements and definitions: roman type;

— test specifications and terms defined in Clause 3 of the general standard, in this particular document

or as noted: italic type; and

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

Normative text of tables is also in a smaller type.
In referring to the structure of this document, the term.

— “clause” means one of the three numbered divisions within the table of contents, inclusive of all

subdivisions (e.g. Clause 201 includes subclauses 201.7, 201.8, etc.); and

— “subclause” means a numbered subdivision of a clause (e.g. 201.7, 201.8 and 201.9 are all

subclauses of Clause 201).

References to clauses within this document are preceded by the term “Clause” followed by the clause

number. References to subclauses within this particular document are by number only.

vi © ISO 2020 – All rights reserved
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ISO 80601-2-67:2020(E)

In this document, the conjunctive “or” is used as an “inclusive or” so a statement is true if any

combination of the conditions is true.
For the purposes of this document, the auxiliary verb:

— “shall” means that conformance with a requirement or a test is mandatory for conformance with

this document;

— "should” means that conformance with a requirement or a test is recommended but is not

mandatory for conformance with this document;

— "may” is used to describe a permission (e.g., permissible way to achieve conformance with a

requirement or test;
— "can" is used to describe a possibility or capability; and
— "must" is used to express an external constraint.

Annex C contains a guide to the marking and labelling requirements in this document.

Annex D contains a summary of the symbols referenced in this document.

An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates

that there is guidance or rationale related to that item in Annex AA.
© ISO 2020 – All rights reserved vii
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INTERNATIONAL STANDARD ISO 80601-2-67:2020(E)
Medical electrical equipment —
Part 2-67:
Particular requirements for basic safety and essential
performance of oxygen conserving equipment
201.1 * Scope, object and related standards
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows:
NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020.
201.1.1 Scope
IEC 60601-1:2005+AMD1:2012, 1.1 is replaced by:

This document is applicable to the basic safety and essential performance of oxygen conserving

equipment, hereafter referred to as ME equipment, in combination with its accessories intended to

conserve supplemental oxygen by delivering gas intermittently and synchronized with the patient's

inspiratory cycle, when used in the home healthcare environment. Oxygen conserving equipment is

typically used by a lay operator.

NOTE 1 Conserving equipment can also be used in professional health care facilities.

This document is also applicable to conserving equipment that is incorporated with other equipment.

[2] [7]

EXAMPLE Conserving equipment combined with a pressure regulator , an oxygen concentrator or liquid

[4]
oxygen equipment .

This document is also applicable to those accessories intended by their manufacturer to be connected to

conserving equipment, where the characteristics of those accessories can affect the basic safety or

essential performance of the conserving equipment.

This document is intended to clarify the difference in operation of various conserving equipment

models, as well as between the operation of conserving equipment and continuous flow oxygen

equipment, by requiring standardized performance testing and labelling.

This document is only applicable to active devices (e.g. pneumatically or electrically powered) and is

not applicable to non-active devices (e.g. reservoir cannulas).

If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems

only, the title and content of that clause or subclause will say so. If that is not the case, the clause or

subclause applies both to ME equipment and to ME systems, as relevant.

Hazards inherent in the intended physiological 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+AMD1:2012, 7.2.13 and 8.4.1.
© ISO 2020 – All rights reserved 1
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ISO 80601-2-67:2020(E)
NOTE 2 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.
201.1.2 Object
IEC 60601-1:2005, 1.2 is replaced by:

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

requirements for conserving equipment [as defined in 201.3.201] and its accessories.

NOTE 1 Accessories are included because accessories can have a significant impact on the basic safety or

essential performance of conserving equipment.
[11] [12]

NOTE 2 This document has been prepared to address the relevant essential principles and labelling

guidances of the International Medical Devices Regulators Forum (IMDRF) as indicated in Annex BB.

NOTE 3 This document has been prepared to address the relevant essential principles of safety and performance

of ISO 16142-1:2016 as indicated in Annex CC.

NOTE 4 This document has been prepared to address the relevant general safety and performance

[10]
requirements of European regulation (EU) 2017/745 as indicated in Annex DD.
201.1.3 Collateral standards
IEC 60601-1:2005+AMD1:2012+AMD2:2020, 1.3 applies with the following addition:

IEC 60601-1-2+AMD1:2020 and IEC 60601-1-6+AMD1:2013+AMD2:2020 apply as modified in Clauses

202 and 206 respectively. IEC 60601-1-3:2008+AMD1:2013 does not apply. All other published

collateral standards in the IEC 60601-1 series apply as published.
201.1.4 Particular standards
Replacement:

In the IEC 60601 series, particular standards define basic safety and essential performance

requirements, and may modify, replace or delete requirements contained in the general standard and

collateral standards as appropriate for the particular ME equipment under consideration.

A requirement of a particular standard takes priority over the general standard.

For brevity, IEC 60601-1+AMD1:2012+AMD2:— is referred to in this document as the general standard.

Collateral standards are referred to by their document number.

The numbering of clauses and subclauses of this document corresponds to that of the general standard

with the prefix “201” (e.g. 201.1 in this document addresses the content of Clause 1 of the general

standard) 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 document addresses the content of Clause 4 of

the IEC 60601-1-2 collateral standard, 206.4 in this document addresses the content of Clause 4 of the

IEC 60601-1-6 collateral standard, etc.). The changes to the text of the general standard are specified by

the use of the following words:

"Replacement" means that the clause or subclause of the general standard or applicable collateral

standard is replaced completely by the text of this document.
2 © ISO 2020 – All rights reserved
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ISO 80601-2-67:2020(E)

"Addition" means that the text of this document is additional to the requirements of the general

standard or applicable collateral standard.

"Amendment" means that the clause or subclause of the general standard or applicable collateral

standard is amended as indicated by the text of this document.

Subclauses, figures or tables which are additional to those of the general standard are numbered

starting from 201.101. However, due to the fact that definitions in the general standard are numbered

3.1 through 3.147, additional definitions in this document are numbered beginning from 201.3.201.

Additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.

Subclauses, figures or tables 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, 206 for

IEC 60601-1-6, etc.

The term "this document" is used to make reference to the general standard, any applicable collateral

standards and this particular document taken together.

Where there is no corresponding clause or subclause in this document, the clause or subclause of the

general standard or applicable collateral standard, although possibly not relevant, applies without

modification; where it is intended that any part of the general standard or applicable collateral

standard, although possibly relevant, is not to be applied, a statement to that effect is given in this

document.
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 60601-1:2005+AMD1:2012+AMD2:2020, Clause 2 applies, except as follows:
Replacement:

ISO 15223-1:— , Medical devices — Symbols to be used with medical device labels, labelling and

information to be supplied — Part 1: General requirements
Addition:

ISO 32:1977, Gas cylinders for medical use — Marking for identification of content

ISO 5359:2014+Amd.1:2017, Low-pressure hose assemblies for use with medical gases

ISO 7000, Graphical symbols for use on equipment — Registered symbols

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

and vacuum
ISO 9000:2015, Quality management systems — Fundamentals and vocabulary
Under preparation. Stage at the time of publication: ISO/DIS 15223-1:2020.
© ISO 2020 – All rights reserved 3
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ISO 80601-2-67:2020(E)

ISO 10524-1:2018, Pressure regulators for use with medical gases — Part 1: Pressure regulators and

pressure regulators with flow-metering devices

ISO 10524-3:2019, Pressure regulators for use with medical gases — Part 3: Pressure regulators

integrated with cylinder valves (VIPRs)

ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a

sterilizing agent and the development, validation and routine control of a sterilization process for medical

devices

ISO 16142-1:2016, Medical devices — Recognized essential principles of safety and performance of

medical devices — Part 1: General essential principles and additional specific essential principles for all

non-IVD medical devices and guidance on the selection of standards

ISO 17664:2017, Processing of health care products — Information to be provided by the medical device

manufacturer for the processing of medical devices

ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications —

Part 1: Evaluation and testing within a risk management process

ISO 19223:2019, Lung ventilators and related equipment — Vocabulary and semantics

ISO 80369-1:2018, Small-bore connectors for liquids and gases in healthcare applications — Part 1:

General requirements

ISO 80601-2-74:2017, Medical electrical equipment — Part 2-74: Particular requirements for basic safety

and essential performance of respiratory humidifying equipment

IEC 60601-1:2005+AMD1:2012+AMD2:2020, Medical electrical equipment — Part 1: General

requirements for basic safety and essential performance

IEC 62366-1:2015, Medical devices — Part 1: Application of usability engineering to medical devices

EN 13544-2:2002+AMD1:2009, Respiratory therapy equipment — Part 2: Tubing and connectors

201.3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 7396-1:2016, ISO 9000:2015,

ISO 16142-1:2016, ISO 17664:2017, ISO 18562-1:2017, ISO 19223:2019, ISO 80369-1:2018, ISO 80601-

2-74:2017, IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-2:2014,
IEC 60601-1-6:2010+AMD1:2013+AMD2:2020, IEC 60601-1-8:2006+AMD1:2012+AMD2:2020,
IEC 60601-1-11:2015, IEC 62366-1:2015 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 alphabetized index of defined terms is found in Annex EE.
Addition:
4 © ISO 2020 – All rights reserved
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ISO 80601-2-67:2020(E)
201.3.201
conserving equipment

ME equipment intended to conserve supplemental oxygen by delivering gas intermittently and

synchronized with the patient's inspiratory cycle

Note 1 to entry: Conserving equipment can be electrically or pneumatically powered.

201.3.202
conserving equipment with monitoring function

conserving equipment suitable for use with patients where monitoring of oxygen delivery via the

conserving equipment is indicated
201.3.203
flow-direction-sensitive component

component or accessory through which gas flow is in one direction only for proper functioning or

patient safety
[1]
[SOURCE: ISO 4135:— , 3.1.4.13, modified—changed ‘must be’ to ‘is’.]
201.4 General requirements
IEC 60601-1:2005+AMD1:2012, Clause 4 applies, except as follows:
201.4.3 Essential performance
IEC 60601-1:2005+AMD1:2012, 4.3 applies, except as follows:
Additional subclause:
201.4.3.101 * Additional requirements for essential performance

Additional essential performance requirements are found in the subclauses listed in Table 201.101.

Under preparation. Stage at the time of publication: ISO/DIS 4135:2020.
© ISO 2020 – All rights reserved 5
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ISO 80601-2-67:2020(E)
Table 201.101 — Distributed essential performance requirements
Requirement Subclause
For conserving equipment with monitoring function, the delivered a
201.12.1.101
oxygen dose, in both normal condition and single fault condition,
within the accuracy as indicated in the instructions for use
or generation of an alarm condition
absence of the inspiratory trigger alarm condition 201.12.4.101
gas supply failure alarm condition 201.12.4.102
For other than conserving equipment with monitoring function, the a
201.12.1.101
delivered oxygen dose, in normal condition, within the accuracy
indicated in the instructions for use
or an indication of abnormal operation

Subclause 202.8.1.101 indicates methods of evaluating delivered oxygen as acceptance

criteria following specific tests required by this document.
201.4.6 * ME equipment or ME system parts that contact the patient
Amendment (add at end of 4.6 prior to the conformance check):

aa) Conserving equipment or its parts or accessories that can come into contact with the patient shall be

subject to the requirements for applied parts according to this subclause (i.e., 4.6 of the general

standard).
201.4.11.101 * Additional requirements for pressurized gas input
201.4.11.101.1 Overpressure requirement

a) Conserving equipment with an operator-detachable oxygen inlet connector as specified in 201.101.1:

1) shall operate and meet the requirements of this document throughout its rated range of input

pressure; and

2) shall not cause an unacceptable risk under the single fault condition of 1 000 kPa.

b) Conserving equipment with an operator-detachable oxygen inlet connector that conforms with

ISO 80369-1:2018, 5.8 shall not cause an unacceptable risk under the single fault condition of twice

the maximum rated input pressure.

NOTE 1 Internal pressure regulators can be required to accommodate the single fault condition of maximum

input pressure as well as the rated range of input pressure.

NOTE 2 Under the single fault condition of overpressure, it is desirable for gas to continue to flow to the patient.

Under this condition, the flowrate from the conserving equipment is likely to be outside of its specification.

Check conformance by functional testing in normal use and under normal condition with the most adverse

operating settings, by functional testing in single fault condition and inspection of the risk management

file.
6 © ISO 2020 – All rights reserved
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ISO 80601-2-67:2020(E)
201.4.11.101.2 Compatibility requirement

If conserving equipment is intended to be connected to a medical gas pipeline system conforming with

ISO 7396-1:2016, then:

a) the rated range of input pressure shall cover the range specified in ISO 7396-1:2016; and

b) under normal condition,

1) the maximum 10 s average input flow required by the conserving equipment shall not exceed

60 l/min at a pressure of 280 kPa, measured at the gas input port; and
2) the transient input flow shall not exceed 200 l/min averaged for 3 s;
or:
3) the accompanying documents shall disclose:

i) the maximum 10 s average input flow required by the conserving equipment at a pressure of

280 kPa, measured at the gas input port;
ii) the maximum transient input flow averaged for 3 s
...

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