Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment

ISO 80601-2-79:2018 This document applies to the basic safety and essential performance of ventilatory support equipment, as defined in 201.3.205, for ventilatory impairment, as defined in 201.3.202, hereafter also referred to as me equipment, in combination with its accessories:
— intended for use in the home healthcare environment;
— intended for use by a lay operator; and
— intended for use with patients who have ventilatory impairment, the most fragile of these patients, would not likely experience injury with the loss of this artificial ventilation; and
— not intended for patients who are dependent on artificial ventilation for their immediate life support.
EXAMPLE 1 Patients with mild to moderate chronic obstructive pulmonary disease (COPD).
NOTE 1 In the home healthcare environment, the supply mains is often not reliable.
NOTE 2 Such ventilatory support equipment can also be used in non-critical care applications of professional health care facilities.
This document is also applicable to those accessories intended by their manufacturer to be connected to the breathing system of ventilatory support equipment for ventilatory impairment, where the characteristics of those accessories can affect the basic safety or essential performance of the ventilatory support equipment for ventilatory impairment.
EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, humidifier, breathing system filter, external electrical power source, distributed alarm system.
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 3 Additional information can be found in IEC 60601‑1:2005+AMD1:2012, 4.2.
This document does not specify the requirements for:
— ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601‑2‑12;
— ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601‑2‑13[4];
— ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601‑2‑84 [5] [1], the future replacement for ISO 10651‑3[6];
— ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601‑2‑72;
— ventilatory support equipment or accessories intended for ventilatory insufficiency, which are given in ISO 80601‑2‑80[1];
— sleep apnoea therapy me equipment, which are given in ISO 80601‑2‑70[7];
— continuous positive airway pressure (CPAP) me equipment;
— high-frequency jet ventilators (HFJVs);
— high-frequency oscillatory ventilators (HFOVs)[8];
— oxygen therapy constant flow me equipment;
— cuirass or "iron-lung" ventilation equipment.
This document is a document in the IEC 60601 and IEC/ISO 80601 series of documents.
[1] Under preparation. Stage at the time of publication: ISO/DIS 80601-2-84:2017.

Appareils électromédicaux - Partie 2-79: Exigences particulières pour la sécurité de base et les performances essentielles des équipements d'assistance ventilatoire en cas de trouble ventilatoire

ISO 80601-2-79:2018 Le présent document s'applique à la sécurité de base et aux performances essentielles des équipements d'assistance ventilatoire, tels que définis en 201.3.205, pour le trouble ventilatoire, tels que définis en 201.3.202, ci-après également désignés par appareils em, en association avec leurs accessoires:
— destinés à être utilisés dans l'environnement des soins à domicile;
— destinés à être utilisés par un opérateur non spécialiste; et
— destinés à être utilisés avec des patients souffrant d'un trouble ventilatoire, les plus fragiles de ces patients ayant peu de risque d'être blessés en cas de perte de cette ventilation artificielle; et
— non destinés à être utilisés chez les patients dont le maintien immédiat des fonctions vitales dépend d'une ventilation artificielle.
EXEMPLE 1 Patients souffrant d'une bronchopneumopathie chronique obstructive (BPCO) légère à modérée.
NOTE 1 Dans l'environnement des soins à domicile, il est fréquent que le réseau d'alimentation ne soit pas fiable.
NOTE 2 Ces équipements d'assistance ventilatoire peuvent également être utilisés dans les établissements de santé professionnels, pour d'autres applications qu'en soins intensifs.
Le présent document s'applique également aux accessoires conçus par leur fabricant pour être raccordés au système respiratoire des équipements d'assistance ventilatoire en cas de trouble ventilatoire, lorsque les caractéristiques de ces accessoires peuvent affecter la sécurité de base ou les performances essentielles des équipements d'assistance ventilatoire en cas de trouble ventilatoire.
EXEMPLE 2 Ensembles respiratoires, raccords, pièges à eau, valve expiratoire, humidificateur, filtre pour système respiratoire, source d'énergie électrique externe et système d'alarme réparti.
Si un article ou un paragraphe est spécifiquement destiné à être applicable uniquement aux appareils em ou uniquement aux systèmes em, le titre et le contenu de cet article ou de ce paragraphe l'indiquent. Dans le cas contraire, 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 3 Des informations supplémentaires peuvent être trouvées dans l'IEC 60601‑1:2005+AMD1:2012, 4.2.
Le présent document ne spécifie pas les exigences relatives aux:
— ventilateurs ou accessoires pour patients ventilo-dépendants prévus pour les applications en soins intensifs, qui sont données dans l'ISO 80601‑2‑12;
— ventilateurs ou accessoires prévus pour les applications en anesthésie, qui sont données dans l'ISO 80601‑2‑13[4];
— ventilateurs ou accessoires destinés à l'environnement des services médicaux d'urgence, qui sont données dans l'ISO 80601‑2‑84[5] [1]), qui remplacera l'ISO 10651‑3[6];
— ventilateurs ou accessoires pour patients ventilo-dépendants dans l'environnement des soins à domicile, qui sont données dans l'ISO 80601‑2‑72;
— équipements d'assistance ventilatoire ou accessoires prévus en cas d'insuffisance ventilatoire, qui sont données dans l'ISO 80601‑2‑80[1];
— appareils em de traitement de l'apnée du sommeil, qui sont données dans l'ISO 80601‑2‑70[7];
— appareils em délivrant une pression positive continue des voies aériennes (PPC);
— jet-ventilateurs à haute fréquence (JVHF);
— ventilateurs à oscillation haute fréquence (VOHF)[8] ;
— appareils em délivrant un débit constant d'oxygénothérapie;
— équipements de ventilation de type cuirasse ou «poumon d'acier».
Le présent document fait partie des séries de documents de l'IEC 60601 et IEC/ISO 80601.
[1]) En cours d?élaboration. État au moment de la parution: ISO/DIS 80601-2-84:2017.

General Information

Status
Published
Publication Date
17-Jul-2018
Current Stage
PPUB - Publication issued
Completion Date
23-Jul-2018
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INTERNATIONAL ISO
STANDARD 80601-2-79
First edition
2018-07
Medical electrical equipment —
Part 2-79:
Particular requirements for basic
safety and essential performance of
ventilatory support equipment for
ventilatory impairment
Appareils électromédicaux —
Partie 2-79: Exigences particulières pour la sécurité de base et les
performances essentielles des équipements d'assistance ventilatoire
en cas de trouble ventilatoire
Reference number
ISO 80601-2-79:2018(E)
ISO 2018
---------------------- Page: 1 ----------------------
ISO 80601-2-79:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

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 2018 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 80601-2-79:2018(E)
Contents

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

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

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

201.2 Normative references ............................................................................................................................... 4

201.3 Terms and definitions .............................................................................................................................. 6

201.4 General requirements .............................................................................................................................. 7

201.5 General requirements for testing of ME EQUIPMENT ......................................................................... 9

201.6 Classification of ME EQUIPMENT and ME SYSTEMS ............................................................................... 10

201.7 ME EQUIPMENT identification, marking and documents .............................................................. 10

201.8 Protection against electrical HAZARDS from ME EQUIPMENT ........................................................ 16

201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS ........................... 16

201.10 Protection against unwanted and excessive radiation HAZARDS ............................................. 17

201.11 Protection against excessive temperatures and other HAZARDS ............................................. 17

201.12 Accuracy of controls and instruments and protection against hazardous outputs ........ 20

201.13 Hazardous situations and fault conditions for ME EQUIPMENT .................................................. 30

201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) ........................................................................ 30

201.15 Construction of ME EQUIPMENT .............................................................................................................. 30

201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS ............................................ 31

201.101 Gas connections ....................................................................................................................................... 31

201.102 Requirements for the VBS and ACCESSORIES ...................................................................................... 33

201.103 * Training ................................................................................................................................................... 34

201.104 * Indication of duration of operation ............................................................................................... 34

201.105 FUNCTIONAL CONNECTION ........................................................................................................................... 35

201.106 Display loops ............................................................................................................................................. 35

201.107 Spontaneous breathing during loss of ventilation ...................................................................... 36

202 Electromagnetic disturbances — Requirements and tests ...................................................... 36

206 Usability ...................................................................................................................................................... 37

211 Requirements for medical electrical equipment and medical electrical

systems used in the home healthcare environment ................................................................... 38

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

and ME SYSTEMS .......................................................................................................................................... 40

Annex D (informative) Symbols on marking ................................................................................................... 46

Annex AA (informative) Particular guidance and rationale ...................................................................... 48

Annex BB (informative) Data interface requirements ................................................................................. 61

Annex CC (informative) Reference to the ESSENTIAL PRINCIPLES .................................................................. 67

Annex DD (informative) Terminology — Alphabetized index of defined terms ................................ 71

Bibliography ................................................................................................................................................................. 75

© ISO 2018 – All rights reserved iii
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ISO 80601-2-79:2018(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. 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. 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.

ISO 80601-2-79 was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory

equipment, Subcommittee SC 3, Lung ventilators and related equipment, and Technical Committee

IEC/TC 62, Electrical equipment in medical practice, Subcommittee SC D, Electrical equipment. The draft

was circulated for voting to the national bodies of both ISO and IEC.
[1]1

This first edition of ISO 80601-2-79, in combination with ISO 80601-2-80 , cancels and replaces

[2]

ISO 10651-6:2004 . This edition of ISO 80601-2-79 constitutes a major technical revision of

ISO 10651-6:2004 and includes an alignment with the third edition of IEC 60601-1, the fourth edition of

IEC 60601-1-2, the third edition of IEC 60601-1-6, the second edition of IEC 60601-1-8 and the second

edition of IEC 60601-1-11.
The most significant changes are the following modifications:
[2]
— splitting the scope of ISO 10651-6:2004 into two parts:

— one for VENTILATORY IMPAIRMENT, also known as RESPIRATORY IMPAIRMENT, (this document) and

— one for VENTILATORY INSUFFIENCY, also known as RESPIRATORY INSUFFICIENCY (ISO 80601-2-80);

— extending the scope to include the VENTILATORY SUPPORT EQUIPMENT and its ACCESSORIES, where the

characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the

VENTILATORY SUPPORT EQUIPMENT, and thus not the VENTILATORY SUPPORT EQUIPMENT itself;

— identification of ESSENTIAL PERFORMANCE for VENTILATORY SUPPORT EQUIPMENT and its ACCESSORIES;

and the following additions:
— tests for ventilation performance;
Numbers in square brackets refer to the Bibliography.
iv © ISO 2018 – All rights reserved
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ISO 80601-2-79:2018(E)
— tests for mechanical strength (via IEC 60601-1-11);
— new symbols;
— requirements for VENTILATORY SUPPORT EQUIPMENT as a component of an ME SYSTEM;
— tests for ENCLOSURE integrity (water ingress via IEC 60601-1-11);
— tests for CLEANING and DISINFECTION PROCEDURES (via IEC 60601-1-11);

— consideration of contamination of the breathing gas delivered to the PATIENT from the GAS PATHWAYS.

© ISO 2018 – All rights reserved v
---------------------- Page: 5 ----------------------
ISO 80601-2-79:2018(E)
Introduction

This document specifies requirements for VENTILATORY SUPPORT EQUIPMENT that is intended for use in the

HOME HEALTHCARE ENVIRONMENT for PATIENTS who are not dependent on ventilation for their life support.

VENTILATORY SUPPORT EQUIPMENT is frequently used in locations where SUPPLY MAINS is not reliable.

VENTILATORY SUPPORT EQUIPMENT is often supervised by non-healthcare personnel (LAY OPERATORS) with

varying levels of training. VENTILATORY SUPPORT EQUIPMENT complying with this document can be used

elsewhere (i.e. in healthcare facilities).

Ventilatory support is often needed for PATIENTS who have stable ventilatory needs. This document

addresses PATIENTS who have significant respiratory dysfunction resulting in an abnormality of a

sufficient degree to be noticeable by the PATIENT. This is best characterized by lung functions not worse

[3]
than :
— FEV /FVC < 70 %; or
— 50 % ≤ FEV < 80 % predicted
where
FEV is the forced expiratory volume in 1 s, and
FVC is the forced vital capacity.
Examples of diseases that require ventilation support are
— mild to moderate Chronic Obstructive Pulmonary Disease (COPD);
— neuromuscular/ amyotrophic lateral sclerosis (ALS);
— obese PATIENTS Obese Hypoventilation Syndrome (OHS);
— Cheyne–Stokes respiration (CSR/CSA).

CSR/CSA is an abnormal pattern of breathing characterized by progressively deeper and sometimes

faster breathing, followed by a gradual decrease that results in a temporary stop in breathing called an

apnoea. The pattern repeats, with each cycle usually taking 30 s to 2 min.

Cardiac PATIENTS with CSR/CSA might be breathless without having significant reduction in FEV .

Reducing the work of breathing can help normalize their breathing.

This VENTILATORY SUPPORT EQUIPMENT is intended for PATIENTS who are spontaneously breathing and do

not require ventilation for life support or intermittent periods of ventilation to maintain vital signs.

VENTILATORY SUPPORT EQUIPMENT intended for this group of PATIENTS typically does not require

PHYSIOLOGICAL ALARM CONDITIONS as no ESSENTIAL PERFORMANCE exists. These PATIENTS can gain adequate

relief from fatigue related to the work of breathing by using VENTILATORY SUPPORT EQUIPMENT during the

night and while taking breaks during the day. This can enable a PATIENT with VENTILATORY IMPAIRMENT to

continue to move about and participate in the activities of daily living. Non-TRANSIT-OPERABLE VENTILATORY

SUPPORT EQUIPMENT that provides ventilatory support at the bedside and beside a chair or other resting

place should be adequate in this application.

This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.

In this document, the following print types are used:
— Requirements and definitions: roman type;
This is also known as the Tiffeneau-Pinelli index.
vi © ISO 2018 – All rights reserved
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ISO 80601-2-79:2018(E)
— Test specifications: italic type;

— 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;

— TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD , IN THIS DOCUMENT OR AS NOTED: SMALL CAPITALS.

In referring to the structure of this document, the term

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

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

— “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.

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.

The verbal forms used in this document conform to usage described in ISO/IEC Directives, Part 2. For the

purposes of this document, the auxiliary verb:

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

document;

— “should” means that compliance with a requirement or a test is recommended but is not mandatory

for compliance with this document;

— “may” is used to describe permission (e.g. a permissible way to achieve compliance with a

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

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.

The ISO and IEC 80601 family of documents are also parts of the IEC 60601 family of documents

The general standard is IEC 60601-1:2005+AMD1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and

essential performance.
© ISO 2018 – All rights reserved vii
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INTERNATIONAL STANDARD ISO 80601-2-79:2018(E)
Medical electrical equipment
Part 2-79:
Particular requirements for the basic safety and essential
performance of ventilatory support equipment for ventilatory
impairment
201.1 Scope, object and related standards
IEC 60601-1:2005+AMD1:2012, Clause 1, applies, except as follows:
201.1.1 * Scope
Replacement:

This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of VENTILATORY SUPPORT EQUIPMENT,

as defined in 201.3.205, for VENTILATORY IMPAIRMENT, as defined in 201.3.202, hereafter also referred to

as ME EQUIPMENT, in combination with its ACCESSORIES:
— intended for use in the HOME HEALTHCARE ENVIRONMENT;
— intended for use by a LAY OPERATOR; and

— intended for use with PATIENTS who have VENTILATORY IMPAIRMENT, the most fragile of these PATIENTS,

would not likely experience injury with the loss of this artificial ventilation; and

— not intended for PATIENTS who are dependent on artificial ventilation for their immediate life support.

EXAMPLE 1 PATIENTS with mild to moderate chronic obstructive pulmonary disease (COPD).

NOTE 1 In the HOME HEALTHCARE ENVIRONMENT, the SUPPLY MAINS is often not reliable.

NOTE 2 Such VENTILATORY SUPPORT EQUIPMENT can also be used in non-critical care applications of professional

health care facilities.

This document is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to

the BREATHING SYSTEM of VENTILATORY SUPPORT EQUIPMENT for VENTILATORY IMPAIRMENT, where the

characteristics of those ACCESSORIES can affect the BASIC SAFETY or ESSENTIAL PERFORMANCE of the

VENTILATORY SUPPORT EQUIPMENT for VENTILATORY IMPAIRMENT.

EXAMPLE 2 Breathing sets, connectors, water traps, expiratory valve, HUMIDIFIER, BREATHING SYSTEM FILTER,

external electrical power source, DISTRIBUTED ALARM SYSTEM.

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 3 Additional information can be found in IEC 60601-1:2005+AMD1:2012, 4.2.
© ISO 2018 – All rights reserved 1
---------------------- Page: 8 ----------------------
ISO 80601-2-79:2018(E)
This document does not specify the requirements for:

— VENTILATORS or ACCESSORIES for VENTILATOR-DEPENDENT PATIENTS intended for critical care applications,

which are given in ISO 80601-2-12;

— VENTILATORS or ACCESSORIES intended for anaesthetic applications, which are given in

[4]
ISO 80601-2-13 ;

— VENTILATORS or ACCESSORIES intended for the emergency medical services environment, which are

[5] [6]
given in ISO 80601-2-84 , the future replacement for ISO 10651-3 ;

— VENTILATORS or ACCESSORIES intended for VENTILATOR-DEPENDENT PATIENTS in the HOME HEALTHCARE

ENVIRONMENT, which are given in ISO 80601-2-72;

— VENTILATORY SUPPORT EQUIPMENT or ACCESSORIES intended for VENTILATORY INSUFFICIENCY, which are

[1]
given in ISO 80601-2-80 ;
[7]
— sleep apnoea therapy ME EQUIPMENT, which are given in ISO 80601-2-70 ;
— continuous positive airway pressure (CPAP) ME EQUIPMENT;
— high-frequency jet VENTILATORS (HFJVs);
[8]
— high-frequency oscillatory VENTILATORS (HFOVs) ;
— oxygen therapy constant flow ME EQUIPMENT;
— cuirass or “iron-lung” ventilation equipment.

This document is a document in the IEC 60601 and IEC/ISO 80601 series of documents.

201.1.2 Object
Replacement:

The object of this document is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE

requirements for VENTILATORY SUPPORT EQUIPMENT, as defined in 201.3.205, and its ACCESSORIES.

NOTE ACCESSORIES are included because the combination of the VENTILATORY SUPPORT EQUIPMENT and the

ACCESSORIES needs to be adequately safe. ACCESSORIES can have a significant impact on the BASIC SAFETY or ESSENTIAL

PERFORMANCE of the VENTILATORY SUPPORT EQUIPMENT.
Under preparation. Stage at the time of publication: ISO/DIS 80601-2-84:2017.
2 © ISO 2018 – All rights reserved
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ISO 80601-2-79:2018(E)
201.1.3 Collateral standards
Addition:

This document refers to those applicable collateral standards that are listed in Clause 2 of the general

standard and Clause 201.2 of this document.

IEC 60601-1-2:2014, IEC 60601-1-6:2010+AMD1:2013, and IEC 60601-1-11:2015 apply as modified in

[26]

Clauses 202, 206 and 211 respectively. IEC 60601-1-3 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 may modify, replace or delete requirements contained in

the general standard, including the collateral standards, as appropriate for the particular ME EQUIPMENT

under consideration, and may add other BASIC SAFETY or ESSENTIAL PERFORMANCE requirements.

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

For brevity, IEC 60601-1:2005+AMD1:2012 is referred to in this particular 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 “2xx”, where xx is the final digits 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, 211.10 in this document addresses the content of Clause 10 of the

IEC 60601-1-11 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.

“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 that 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, 203 for

IEC 60601-1-3, etc.

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

standards and this particular standard taken together.

Where there is no corresponding clause or subclause in this particular 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 particular

document.
© ISO 2018 – All rights reserved 3
---------------------- Page: 10 ----------------------
ISO 80601-2-79:2018(E)
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.

NOTE 1 The way in which these referenced documents are cited in normative requirements determines the

extent (in whole or in part) to which they apply.
NOTE 2 Informative references are listed in the Bibliography.
IEC 60601-1:2005+AMD1:2012, Clause 2, applies, except as follows:
Replacement:

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

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

and essential performance — Collateral standard: Usability +Amendment 1:2013+Amendment 1:2013

IEC 60601-1-8:2006 , Medical electrical equipment — Part 1-8: General requirements for basic safety and

essential performance — Collateral standard: General requirements, tests and guidance for alarm systems

in medical electrical equipment and medical electrical systems+Amendment 1:2012

IEC 60601-1-11:2015, Medical electrical equipment — Part 1-11: General requirements for basic safety and

essential performance — Collateral standard: Requirements for medical electrical equipment and medical

electrical systems used in the home healthcare environment
IEC 61672-1:2013, Electroacoustics — Sound level meters — Part 1: Specifications
Addition:

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 4135:2001, Anaesthetic and respiratory equipment — Vocabulary

ISO 4871:1996, Acoustics — Declaration and verification of noise emission values of machinery and

equipment

ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and

sockets

ISO 5367:2014, 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 8836:2014, Suction catheters for use in the respiratory tract
ISO 9000:2015, Quality management systems — Fundamentals and vocabulary

There exists a consolidated edition 3.1(2013) including IEC 60601-1-6:2010 and its Amendment 1:2013.

There exists a consolidated edition 2.1(2012) including IEC 60601-1-8:2006 and its Amendment 1:2012.

4 © ISO 2018 – All rights reserved
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ISO 80601-2-79:2018(E)

ISO 9360-1:2000, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for

humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml

ISO 9360-2:2001, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for

humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having

minimum tidal volumes of 250 ml

ISO 15223-1:2016, Medical devices — Symbols to be used with medical device labels, labelling and

information to be supplied — Part 1: General requirements

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 17510:2015, Medical devices — Sleep apnoea breathing therapy — Masks and application accessories

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 23328-1:2003, Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method

to assess filtration performance

ISO 23328-2:2002, Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration

aspects

ISO 80369-1:2010, Small-bore connectors for liquids and gases in healthcare applications — Part 1:

General requirements

ISO 80369-7:2016, Small-bore connectors for liquids and gases in healthcare applications — Part 7:

Connectors for intravascular or hypodermic applications

ISO 80601-2-12:— , Medical electrical equipment — Part 2-12: Particular requirements for basic safety

and essential performance of critical care ventilators

ISO 80601-2-72:2015, Medical electrical equipment — Part 2-72: Particular requirements for basic safety

and essential performance of home healthcare environment ventilators for ventilator-dependent patients

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

and essential performance of respiratory humidifying equipment

, Medical electrical equipment — Part 1: General requirements for basic safety and

IEC 60601-1:2005
essential performance +Amendment 1:2012

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

EN 15986:2011, Symbol for use in the labelling of medical devices — Requirements for labelling of medical

devices containing phthalates
To be published. Stage at time of publication ISO/FDIS 80601-2-12:2018.

There exists a consolidated edition 3.1(2012) including IEC 60601-1:2005 and its Amendment 1:2012.

© ISO 2018 – All rights reserved 5
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ISO 80601-2-79:2018(E)
201.3 Terms and definitions

For the purposes of this document, the terms and definitions given in ISO 4135:2001, ISO 7396-1:2016,

ISO 8836:2014, ISO 9000:2015, ISO 9360-1:2000, ISO 16142-1:2016, ISO 17510:2015, ISO 17664:2

...

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