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

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 ventilation such as patients with central sleep apnoea.
This document 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.
Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document.
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 7.2.13 and 8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.
This document is not applicable to high-frequency jet ventilators (HFJVs) or high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601-2-87[13].
This document does not specify the requirements for ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, which are given in ISO 80601‑2‑12.
This document does not specify the requirements for ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13[8].
This document does not specify the requirements for ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72[9].
This document does not specify the requirements for ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84[12].
This document does not specify the requirements for ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601-2-79[10] and ISO 80601‑2‑80[11].

General Information

Status
Published
Publication Date
19-Nov-2020
Current Stage
PPUB - Publication issued
Completion Date
20-Nov-2020
Ref Project

Buy Standard

Standard
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
English language
68 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (sample)

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
---------------------- Page: 1 ----------------------
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
---------------------- Page: 2 ----------------------
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
---------------------- Page: 3 ----------------------
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

206  Usability ......................................................................................................................................................... 31

211  Requirements for medical electrical equipment and medical electrical systems used

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

iv © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
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
---------------------- Page: 5 ----------------------
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
---------------------- Page: 6 ----------------------
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
---------------------- Page: 7 ----------------------
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
---------------------- Page: 8 ----------------------
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 ventilation such as patients with central sleep apnoea.

This document 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.

Masks and application accessories intended for use during sleep apnoea breathing therapy are

additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this

document.

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.
© ISO 2020 – All rights reserved
---------------------- Page: 9 ----------------------
ISO 80601-2-70:2020(E)

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 7.2.13 and

8.4.1 of the general standard.
NOTE See also 4.2 of the general standard.

This document is not applicable to high‐frequency jet ventilators (HFJVs) or high‐frequency oscillatory

[13]
ventilators (HFOVs), which are given in ISO 80601‐2‐87 .

This document does not specify the requirements for ventilators or accessories intended for critical care

ventilators for ventilator‐dependent patients, which are given in ISO 80601‐2‐12.

This document does not specify the requirements for ventilators or accessories intended for anaesthetic

[8]
applications, which are given in ISO 80601‐2‐13 .

This document does not specify the requirements for ventilators or accessories intended for home care

[9]

ventilators for ventilator‐dependent patients, which are given in ISO 80601‐2‐72 .

This document does not specify the requirements for ventilators or accessories intended for emergency

[12]
and transport, which are given in ISO 80601‐2‐84 .

This document does not specify the requirements for ventilators or accessories intended for home‐care

[10] [11]
ventilatory support, which are given in ISO 80601‐2‐79 and ISO 80601‐2‐80 .
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 sleep apnoea breathing therapy equipment (as defined in 201.3.215).

[17] [18]

NOTE 1 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 CC.

NOTE 2 This document has been prepared to address the relevant essential principles of safety and performance of

ISO 16142‐1:2016 as indicated in Annex DD.

NOTE 3 This document has been prepared to address the relevant general safety and performance requirements of

[16]
European regulation (EU) 2017/745 as indicated in Annex EE.
201.1.3 Collateral standards
IEC 60601‐1:2005+AMD1:2012+AMD2:2020, 1.3 applies with the following addition:

IEC 60601‐1‐2:2014+AMD1:2020 and IEC 60601‐1‐6:2010+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:
© ISO 2020 – All rights reserved
---------------------- Page: 10 ----------------------
ISO 80601-2-70:2020(E)

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+AMD2:2020 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, 203.4 in this document addresses the content of Clause 4 of the

IEC 60601‐1‐3 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 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 3.139, 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 standar
...

Questions, Comments and Discussion

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