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

Name:ISO 80601-2-70:2020   Standard name:Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
Standard number:ISO 80601-2-70:2020   language:English language
Release Date:19-Nov-2020   technical committee:SC 62D - Particular medical equipment, software, and systems
Drafting committee:JWG 12 - TC 62/SC 62D/JWG 12   ICS number:11.040.10 - Anaesthetic, respiratory and reanimation equipment

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 2020
© 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
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CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: [email protected]
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Published in Switzerland
ii © ISO 2020 – All rights reserved

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

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

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) R
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