Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment (ISO 80601-2-70:2020)

This particular standard is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.
This particular standard excludes sleep apnoea breathing therapy equipment intended for use with neonates.
This particular standard is applicable to me equipment or an ME system intended for those patients who are not dependent on mechanical ventilation such as patients with central sleep apnoea.
This particular standard is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment.

Medizinische elektrische Geräte - Teil 2-70: Besondere Festlegungen für die Sicherheit und die wesentlichen Leistungsmerkmale von Schlafapnoe-Atemtherapiegeräten (ISO 80601-2-70:2020)

IEC 60601-1:2005+Änderung 1:2012, 1.1 wird ersetzt durch:
Dieses Dokument gilt für die Basissicherheit und die wesentlichen Leistungsmerkmale von Schlafapnoe-Atemtherapiegeräten, nachfolgend als ME-Geräte bezeichnet, die dafür vorgesehen sind, die Symptome von unter der obstruktiven Schlafapnoe leidenden Patienten zu lindern, indem diesen Patienten ein therapeutischer Atemdruck im Atemtrakt zugeführt wird. Schlafapnoe-Atemtherapiegeräte sind für die Anwendung sowohl in der medizinischen Versorgung in häuslicher Umgebung durch nicht fachkundige Bediener als auch in Einrichtungen des Gesundheitswesens vorgesehen.
* Für Schlafapnoe-Atemtherapiegeräte wird keine Verwendung von physiologischen geschlossenen Regelkreissystemen angenommen, es sei denn, es wird eine physiologische Patientenvariable verwendet, um die Therapieeinstellungen anzupassen.
Dieses Dokument deckt keine Schlafapnoe-Atemtherapiegeräte für Neugeborene ab.
Dieses Dokument ist auf ME-Geräte oder ME-Systeme anwendbar, die für Patienten vorgesehen sind, die nicht von mechanischer Beatmung abhängig sind.
Dieses Dokument ist nicht auf ME-Geräte oder ME-Systeme anwendbar, die für Patienten vorgesehen sind, die von mechanischer Beatmung abhängig sind, wie dies bei Patienten mit zentraler Schlafapnoe der Fall wäre.
Dieses Dokument gilt auch für Zubehör, das durch den Hersteller für den Anschluss an Schlafapnoe-Atemtherapiegeräte vorgesehen ist, sofern die Merkmale dieses Zubehörs die Basissicherheit oder die wesentlichen Leistungsmerkmale der Schlafapnoe-Atemtherapiegeräte beeinflussen können.
Masken und Anwendungs-Zubehör für die Anwendung bei der Schlafapnoe-Atemtherapie werden ebenfalls in der ISO 17510 behandelt. Siehe Bild AA.1 für die von diesem Dokument weiteren abgedeckten Gegenstände.
Wenn ein Abschnitt oder Unterabschnitt speziell nur auf ME-Geräte oder ME-Systeme angewendet werden soll, wird dies aus der Überschrift und dem Inhalt des jeweiligen Abschnitts oder Unterabschnitts deutlich. Ist dies nicht der Fall, gilt der Abschnitt oder Unterabschnitt, je nach Zutreffen, für das ME-Gerät und das ME-System.
Gefährdungen, die sich aus der vorgesehenen physiologischen Wirkungsweise von ME-Geräten oder ME-Systemen nach dem Anwendungsbereich dieses Dokuments ergeben, sind nicht durch spezifische Anforderungen in diesem Dokument erfasst, ausgenommen bei 7.2.13 und 8.4.1 der Allgemeinen Festlegungen.
ANMERKUNG Siehe auch 4.2 der allgemeinen Norm.
Dieses Dokument gilt nicht für Hochfrequenz-Jet-Beatmungsgeräte (HFJVs) oder Hochfrequenz-Oszillations-Beatmungsgeräte (HFOVs) nach ISO 80601-2-87[13].
Dieses Dokument legt keine Anforderungen an Beatmungsgeräte oder Zubehör von Beatmungsgeräten für die Intensivpflege für von Beatmungsgeräten abhängige Patienten fest, die in ISO 80601 2 12 enthalten sind.
Dieses Dokument legt keine Anforderungen an Beatmungsgeräte oder Zubehör für anästhetische Anwendungen fest, die in ISO 80601-2-13[8] enthalten sind.
Dieses Dokument legt keine Anforderungen an Beatmungsgeräte oder Zubehör von Beatmungsgeräten für von Heimbeatmungsgeräten abhängige Patienten fest, die in ISO 80601-2-72[9] enthalten sind.
Dieses Dokument legt keine Anforderungen an Beatmungsgeräte oder Zubehör für Notfälle und den Transport fest, die in ISO 80601-2-84[13] enthalten sind.
Dieses Dokument legt keine Anforderungen an Beatmungsgeräte oder Zubehör für Heimbeatmungsgeräte zur Atemunterstützung fest, die in ISO 80601-2-79[10] und ISO 80601 2 80[11] enthalten sind.

Appareils électromédicaux - Partie 2-70: Exigences particulières pour la sécurité de base et les performances essentielles de l'équipement de thérapie respiratoire pour l'apnée du sommeil (ISO 80601-2-70:2020)

Medicinska električna oprema - 2-70. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za zdravljenje prenehanja dihanja v spanju (ISO 80601-2-70:2020)

General Information

Status
Published
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
25-Nov-2020
Completion Date
25-Nov-2020

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SLOVENSKI STANDARD
SIST EN ISO 80601-2-70:2021
01-januar-2021
Nadomešča:
SIST EN ISO 17510-1:2009
Medicinska električna oprema - 2-70. del: Posebne zahteve za osnovno varnost in

bistvene lastnosti opreme za zdravljenje prenehanja dihanja v spanju (ISO 80601-2

-70:2020)

Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and

essential performance of sleep apnoea breathing therapy equipment (ISO 80601-2-
70:2020)

Medizinische elektrische Geräte - Teil 2-70: Besondere Festlegungen für die Sicherheit

und die wesentlichen Leistungsmerkmale von Schlafapnoe-Atemtherapiegeräten (ISO
80601-2-70:2020)

Appareils électromédicaux - Partie 2-70: Exigences particulières pour la sécurité de base

et les performances essentielles de l'équipement de thérapie respiratoire pour l'apnée du

sommeil (ISO 80601-2-70:2020)
Ta slovenski standard je istoveten z: EN ISO 80601-2-70:2020
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
SIST EN ISO 80601-2-70:2021 en

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

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SIST EN ISO 80601-2-70:2021
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SIST EN ISO 80601-2-70:2021
EN ISO 80601-2-70
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2020
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 17510-1:2009
English Version
Medical electrical equipment - Part 2-70: Particular
requirements for the basic safety and essential
performance of sleep apnoea breathing therapy equipment
(ISO 80601-2-70:2020)

Appareils électromédicaux - Partie 2-70: Exigences Medizinische elektrische Geräte - Teil 2-70: Besondere

particulières pour la sécurité de base et les Festlegungen für die Sicherheit und die wesentlichen

performances essentielles de l'équipement de thérapie Leistungsmerkmale von Schlafapnoe-

respiratoire pour l'apnée du sommeil (ISO 80601-2- Atemtherapiegeräten (ISO 80601-2-70:2020)

70:2020)
This European Standard was approved by CEN on 19 October 2020.

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

© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-70:2020 E

worldwide for CEN national Members.
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SIST EN ISO 80601-2-70:2021
EN ISO 80601-2-70:2020 (E)
Contents Page

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

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SIST EN ISO 80601-2-70:2021
EN ISO 80601-2-70:2020 (E)
European foreword

This document (EN ISO 80601-2-70:2020) 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 2021, and conflicting national standards shall be

withdrawn at the latest by May 2021.

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 17510-1:2009.

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 80601-2-70:2020 has been approved by CEN as EN ISO 80601-2-70:2020 without any

modification.
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SIST EN ISO 80601-2-70:2021
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SIST EN ISO 80601-2-70:2021
INTERNATIONAL ISO
STANDARD 80601-2-70
Second edition
2020-11
Medical electrical equipment —
Part 2-70:
Particular requirements for the basic
safety and essential performance
of sleep apnoea breathing therapy
equipment
Appareils électromédicaux —
Partie 2-70: Exigences particulières pour la sécurité de base et les
performances essentielles de l'équipement de thérapie respiratoire
pour l'apnée du sommeil
Reference number
ISO 80601-2-70:2020(E)
ISO 2020
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SIST EN ISO 80601-2-70:2021
ISO 80601-2-70:2020(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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SIST EN ISO 80601-2-70:2021
ISO 80601-2-70:2020(E)
Contents Page

Foreword ....................................................................................................................................................................... vi

Introduction ................................................................................................................................................................ vii

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

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

201.1.2 Object ............................................................................................................................................................... 2

201.1.3 Collateral standards ................................................................................................................................... 2

201.1.4 Particular standards .................................................................................................................................. 2

201.2  Normative references ................................................................................................................................. 3

201.3  Terms and definitions ................................................................................................................................. 4

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

201.4.3 Essential performance .................................................................................................................................. 7

201.4.3.101 * Additional requirements for essential performance............................................................ 7

201.4.6 * ME equipment or ME system parts that contact the patient ...................................................... 7

201.5  General requirements for testing of ME equipment ......................................................................... 8

201.5.101 Additional requirements for general requirements for testing of

ME equipment................................................................................................................................................ 8

201.5.101.1 Gas flowrate and pressure specifications .......................................................................... 8

201.5.101.2 * Sleep apnoea breathing therapy equipment testing errors ...................................... 8

201.6  Classification of ME equipment and ME systems ................................................................................ 8

201.7  ME equipment identification, marking and documents .................................................................. 8

201.7.1.2 * Legibility of markings ........................................................................................................................... 8

201.7.2.4.101 Additional requirements for accessories ................................................................................. 9

201.7.2.13.101 Additional requirements for physiological effects ........................................................... 9

201.7.2.17.101 * Additional requirements for protective packaging ...................................................... 9

201.7.2.101 Additional requirements for marking on the outside of ME equipment or

ME equipment parts .................................................................................................................................. 10

201.7.4.3 Units of measurement ............................................................................................................................ 10

201.7.9.1 * Additional general requirements ................................................................................................... 10

201.7.9.2 Instructions for use ................................................................................................................................. 11

201.7.9.2.1.101 Additional general requirements ......................................................................................... 11

201.7.9.2.2.101 Additional requirements for warnings and safety notices ........................................ 11

201.7.9.2.5.101 Additional requirements for ME equipment description ............................................ 12

201.7.9.2.9.101 Additional requirements for operating instructions .................................................... 12

201.7.9.2.12 Cleaning, disinfection, and sterilization ..................................................................................... 12

201.7.9.2.14.101 Additional requirements for accessories, supplementary

equipment, used material ................................................................................................................... 13

201.7.9.3.1.101 * Additional general requirements ...................................................................................... 13

201.8  Protection against electrical hazards from ME equipment .......................................................... 14

201.9  Protection against mechanical hazards of ME equipment and ME systems ............................ 14

201.9.6.2.1.101 * Additional requirements for audible acoustic energy .............................................. 14

201.10 Protection against unwanted and excessive radiation hazards ................................................ 16

201.11 Protection against excessive temperatures and other hazards ................................................ 16

201.11.1.2.2 Applied parts not intended to supply heat to a patient ...................................................... 16

© ISO 2020 – All rights reserved iii
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SIST EN ISO 80601-2-70:2021
ISO 80601-2-70:2020(E)

201.11.6.6 * Cleaning and disinfection of ME equipment or ME system ................................................. 17

201.11.7 Biocompatibility of ME equipment and ME systems ..................................................................... 17

201.11.8 Additional requirements for interruption of the power supply/supply mains

to ME equipment ........................................................................................................................................ 18

201.12 Accuracy of controls and instruments and protection against hazardous outputs ........... 18

201.12.1 * Accuracy of controls and instruments .......................................................................................... 18

201.12.1.101 Stability of static airway pressure accuracy (long‐term accuracy) ..................... 19

201.12.1.102 Stability of dynamic airway pressure accuracy (short‐term accuracy) ............ 20

201.12.1.102.1 CPAP mode ............................................................................................................................. 20

201.12.1.102.2 Bi-level positive airway pressure mode, pressure stability ................................. 22

201.12.1.103 * Maximum flowrate .............................................................................................................. 24

201.12.4 Protection against hazardous output ............................................................................................... 25

201.12.4.101 Measurement of airway pressure ...................................................................................... 25

201.12.4.102 * Maximum limited pressure protection device ............................................................ 25

201.12.4.103 * CO rebreathing .................................................................................................................... 26

201.13 Hazardous situations and fault conditions ........................................................................................ 26

201.14 Programmable electrical medical systems (PEMS) ......................................................................... 26

201.15 Construction of ME equipment ............................................................................................................... 26

201.15.101 Mode of operation ............................................................................................................................... 26

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

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

201.101 Breathing gas pathway connectors .................................................................................................. 27

201.101.1 General ....................................................................................................................................................... 27

201.101.2 Other named ports ................................................................................................................................ 27

201.101.2.1 Patient-connection port ........................................................................................................... 27

201.101.2.2 Gas output port ............................................................................................................................ 27

201.101.2.3 Flow-direction-sensitive components .................................................................................. 28

201.101.2.4 Ancillary port ............................................................................................................................... 28

201.101.2.5 Monitoring probe port ............................................................................................................. 28

201.101.2.6 Oxygen inlet port ....................................................................................................................... 28

201.102 Requirements for the breathing gas pathway and accessories .............................................. 28

201.102.1 * General .................................................................................................................................................... 28

201.102.2 Labelling .................................................................................................................................................... 29

201.102.3 Humidification ......................................................................................................................................... 29

201.102.4 Breathing system filter (BSF) ............................................................................................................. 29

201.103 Functional connection ............................................................................................................................ 29

201.103.1 General ....................................................................................................................................................... 29

201.103.2 * Functional connection to support remote supervision ........................................................ 30

201.104 Training ...................................................................................................................................................... 30

202  Electromagnetic disturbances — Requirements and tests ......................................................... 30

202.4.3.1 Configurations ........................................................................................................................................... 30

202.5.2.2.1 Requirements applicable to all ME equipment and ME systems ........................................ 30

202.8.1.101 Additional general requirements ................................................................................................. 30

......................................................................................................................................................... 31

206  Usability

211  Requirements for medical electrical equipment and medical electrical systems used

in the home healthcare environment ................................................................................................. 31

iv © ISO 2020 – All rights reserved
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SIST EN ISO 80601-2-70:2021
ISO 80601-2-70:2020(E)

211.4.2.3.1 Continuous operating conditions .................................................................................................. 31

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

ME systems ..................................................................................................................................................... 33

Annex D (informative) Symbols on marking ................................................................................................. 38

Annex AA (informative) Particular guidance and rationale .................................................................... 39

Annex BB (informative) Data interface requirements ............................................................................... 48

Annex CC (informative) Reference to the IMDRF essential principles and labelling guidances .. 52

Annex DD (informative) Reference to the essential principles ................................................................ 56

Annex EE (informative) Reference to the general safety and performance requirements .......... 59

Annex FF (informative) Terminology — alphabetized index of defined terms ................................ 63

Bibliography ............................................................................................................................................................... 66

© ISO 2020 – All rights reserved v
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SIST EN ISO 80601-2-70:2021
ISO 80601-2-70:2020(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 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 80601‐2‐70:2015), which has been

technically revised.
The main changes compared to the previous edition are as follows:

— modification of the bi‐level positive airway pressure mode stability test method;

— modification of the biocompatibility requirements;
— reformatting to provide a unique identifier for each requirement;
— harmonization with the ‘A2 project’ of the general standard.

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

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.
vi © ISO 2020 – All rights reserved
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SIST EN ISO 80601-2-70:2021
ISO 80601-2-70:2020(E)
Introduction

Sleep apnoea is a chronic medical condition where the patient repeatedly stops breathing during sleep.

These episodes typically last 10 s or more and cause the oxygen levels in the blood to drop. It can be

caused by obstruction of the upper airway (obstructive sleep apnoea or OSA) or by a failure of the brain

to initiate a breath (central sleep apnoea).

NOTE Sleep apnoea breathing therapy equipment is intended for the treatment of obstructive sleep apnoea

and not central sleep apnoea.

Sleep apnoea, if untreated, can cause and worsen other medical conditions, including hypertension,

[22]
heart failure and diabetes .

Hypopnoea refers to a transient reduction of airflow, often while the patient is asleep, that lasts for at

least 10 s, shallow breathing. It also results in arousal or can cause oxygen saturation to drop.

[20]

Hypopnoea is less severe than apnoea. It is commonly due to partial obstruction of the upper airway .

Awareness of the risks associated with obstructive sleep apnoea has grown significantly. As a result, the

use of sleep apnoea breathing therapy equipment to treat obstructive sleep apnoea has become common.

This document covers basic safety and essential performance requirements needed to protect patients in

the use of this ME equipment.

This document covers sleep apnoea breathing therapy equipment for patient use. ISO 17510 applies to

masks and accessories used to connect sleep apnoea breathing therapy equipment to the patient.

Figure AA.1 shows this diagrammatically.
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 document or as noted:

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;
In referring to the structure of this document, the term.

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

subdivisions (e.g. Clause 201 includes subclauses 201.1, 201.2, etc.);

— “subclause” means a numbered subdivision of a clause (e.g. 201.101, 201.102 and 201.102.1 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 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.
For the purposes of this document, the auxiliary verb:
© ISO 2020 – All rights reserved vii
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SIST EN ISO 80601-2-70:2021
ISO 80601-2-70:2020(E)

– “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. a 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.
viii © ISO 2020 – All rights reserved
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SIST EN ISO 80601-2-70:2021
INTERNATIONAL STANDARD ISO 80601-2-70:2020(E)
Medical electrical equipment —
Part 2‐70:
Particular requirements for the basic safety and essential
performance of sleep apnoea breathing therapy 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+Amendment 1:2012, 1.1 is replaced by:

This document is applicable to the basic safety and essential performance of sleep apnoea breathing

therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of

patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the

respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the

home healthcare environment by lay operators as well as in professional healthcare institutions.

* Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control

system unless it uses a physiological patient variable to adjust the therapy settings.

This document excludes sleep apnoea breathing therapy equipment intended for use with neonates.

This document is applicable to ME equipment or an ME system intended for those patients who are not

dependent on mechanical ventilation.

This document is not applicable to ME equipment or an ME system intended for those patients who are

dependent on mechanical ventila
...

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