ISO 80601-2-70:2015

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

ISO 80601-2-70:2015 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. It excludes sleep apnoea breathing therapy equipment intended for use with neonates. ISO 80601-2-70:2015 is applicable to me equipment or an me system intended for those patients who are not dependent on mechanical ventilation. ISO 80601-2-70:2015 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. ISO 80601-2-70:2015 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.

Appareils électromédicaux - Partie 2-70: Exigences particulières pour la sécurité de base et les performances essentielles du matériel de traitement respiratoire de l'apnée du sommeil

ISO 80601-2-70:2015 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. It excludes sleep apnoea breathing therapy equipment intended for use with neonates. ISO 80601-2-70:2015 is applicable to me equipment or an me system intended for those patients who are not dependent on mechanical ventilation. ISO 80601-2-70:2015 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. ISO 80601-2-70:2015 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.

General Information

• Status: Published
• Publication Date: 11-Jan-2015
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: JWG 12 - TC 62/SC 62D/JWG 12
• Current Stage: DELPUB - Deleted Publication
• Start Date: 15-Feb-2019
• Completion Date: 20-Nov-2020

Relations

• Revised: 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
• Effective Date: 05-Sep-2023

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 80601-2-70
First edition
2015-01-15
Medical electrical equipment —
Part 2-70:
Particular requirements for 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 2015
©  ISO 2015
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2015 – All rights reserved

Contents Page
Foreword . vi
Introduction . viii
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 . 5
201.4 General requirements . 6
201.4.3 ESSENTIAL PERFORMANCE . 6
201.4.3.101 Additional requirements for ESSENTIAL PERFORMANCE . 6
201.4.6 ME EQUIPMENT or ME SYSTEM parts that contact the PATIENT . 6
201.5 General requirements for testing of ME EQUIPMENT . 6
201.5.101 Additional requirements for general requirements for testing of ME EQUIPMENT . 7
201.5.101.1 Gas flowrate and pressure specifications . 7
201.5.101.2 SLEEP APNOEA BREATHING THERAPY EQUIPMENT testing errors . 7
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 7
201.7 ME EQUIPMENT identification, marking and documents . 7
201.7.1.2 Legibility of markings . 7
201.7.2.4.101 Additional requirements for ACCESSORIES . 7
201.7.2.13.101 Additional requirements for physiological effects . 7
201.7. .17.101 Additional requirements for protective packaging . 8
201.7.2.101 Additional requirements for marking on the outside of ME EQUIPMENT or
ME EQUIPMENT parts . 8
201.7.4.3 Units of measurement . 8
201.7.9.1 Additional general requirements . 9
201.7.9.2.1.101 Additional general requirements . 9
201.7.9.2.2.101 Additional requirements for warnings and safety notices . 9
201.7.9.2.9.101 Additional requirements for operating instructions . 10
201.7.9.2.14.101 Additional requirements for ACCESSORIES, supplementary equipment, used
material . 10
201.7.9.3.1.101 Additional general requirements . 10
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 11
201.9 Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS . 11
201.9.6.2.1.101 Additional requirements for audible acoustic energy . 11
201.10 Protection against unwanted and excessive radiation HAZARDS . 13
201.11 Protection against excessive temperatures and other HAZARDS . 13
201.11.1.2.2 APPLIED PARTS not intended to supply heat to a PATIENT . 13
201.11.6.4 Leakage . 13
201.11.8 Additional requirements for interruption of the power supply/SUPPLY MAINS to
ME EQUIPMENT . 14
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 14
201.12.1 Accuracy of controls and instruments . 14
201.12.1.101 Stability of static AIRWAY PRESSURE ACCURACY (long-term accuracy) . 14
201.12.1.102 Stability of dynamic AIRWAY PRESSURE ACCURACY (short-term accuracy) . 15
201.12.1.102.1 CPAP mode .15
201.12.1.102.2 BI-LEVEL POSITIVE AIRWAY PRESSURE mode .17
201.12.1.103 Maximum flowrate .19
201.12.4 Protection against hazardous output .20
201.12.4.101 Measurement of AIRWAY PRESSURE .20
201.12.4.102 MAXIMUM LIMITED PRESSURE PROTECTION DEVICE .20
201.12.4.103 CO rebreathing.20
201.13 HAZARDOUS SITUATIONS and fault conditions .21
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .21
201.15 Construction of ME EQUIPMENT .21
201.15.101 Mode of operation.21
201.16 ME SYSTEMS .21
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .21
201.17.101 Additional requirements for electromagnetic compatibility of ME EQUIPMENT and
ME SYSTEMS .21
201.101 BREATHING GAS PATHWAY connectors .21
201.101.1 General .21
201.101.2 Other named ports .22
201.101.2.1 PATIENT-CONNECTION PORT .22
201.101.2.2 GAS OUTPUT PORT .22
201.101.2.3 FLOW-DIRECTION-SENSITIVE COMPONENTS .22
201.101.2.4 Ancillary port .22
201.101.2.5 Monitoring probe port .22
201.102 Requirements for the BREATHING GAS PATHWAY and ACCESSORIES .23
201.102.1 General .23
201.102.2 Labelling .23
201.102.3 Humidification .23
201.102.4 BREATHING SYSTEM FILTER (BSF) .23
201.103 FUNCTIONAL CONNECTION .23
201.103.1 General .23
201.103.2 FUNCTIONAL CONNECTION to support remote supervision .23
201.104 Training .24
202 Medical electrical equipment – Part 1-2: General requirements for basic safety and
essential performance – Collateral standard: Electromagnetic disturbances –
Requirements and tests .24
202.4.3.1 Compliance criteria .24
202.5.2.2.1 Requirements applicable to all ME EQUIPMENT and ME SYSTEMS .24
202.8.1.101 Additional general requirements .24
206 Medical electrical equipment – Part 1-6: General requirements for basic safety and
essential performance – Collateral Standard: Usability .25
208 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 .25
211 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 .25
ANNEX C (informative) Guide to marking and labelling requirements for ME EQUIPMENT and
ME SYSTEMS .26
iv © ISO 2015 – All rights reserved

Annex D (informative) Symbols on marking . 30
Annex AA (informative) Particular guidance and rationale . 31
Annex BB (informative) Data interface requirements . 35
Annex CC (informative) Reference to the Essential Principles . 39
Bibliography . 41
Alphabetized index of defined terms used in this particular standard . 43

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
...

NORME ISO
INTERNATIONALE 80601-2-70
Première édition
2015-01-15
Appareils électromédicaux —
Partie 2-70:
Exigences particulières pour la sécurité
de base et les performances essentielles
du matériel de traitement respiratoire de
l'apnée du sommeil
Medical electrical equipment —
Part 2-70: Particular requirements for basic safety and essential
performance of sleep apnoea breathing therapy equipment

Numéro de référence
©
ISO 2015
© ISO 2015
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56  CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail [e-mail]
Web www.iso.org
Published in Switzerland
ii © ISO 2015 – Tous droits réservés

Sommaire Page
Avant-propos . vi

Introduction viii
201.1 Domaine d'application, objet et normes connexes . 1
201.1. 1  Domaine d'application . 1

201.1. 2  Objet . 2
201.1. 3  Normes collatérales . 2
201.1. 4  Normes particulières . 3
201.2 Références normatives . 3
201.3 Termes et définitions . 5
201.4 Exigences générales . 6
201.4. 3  PERFORMANCES ESSENTIELLES . 7
201.4. 3.101  Exigences supplémentaires concernant les PERFORMANCES ESSENTIELLES . 7
201.4. 6  Parties d'APPAREIL EM ou de SYSTEME EM en contact avec le PATIENT . 7
201.5 Exigences générales concernant les essais d'un APPAREIL EM . 7
201.5. 101  Exigences supplémentaires s'ajoutant aux exigences générales concernant les
essais d’un APPAREIL EM . 7
201.5. 101.1  Spécifications relatives au débit de gaz et à la pression . 7
201.5. 101.2  Tests d'erreurs lors des essais des MATERIELS DE TRAITEMENT RESPIRATOIRE DE
L'APNEE DU SOMMEIL . 7
201.6 Classification des APPAREILS EM et des SYSTEMES EM . 7
201.7 Identification, marquage et documentation des APPAREILS EM . 8
201.7. 1.2  Lisibilité des marquages . 8
201.7. 2.4.101  Exigences supplémentaires applicables aux ACCESSOIRES . 8
201.7. 2.13.101  Exigences supplémentaires concernant les effets physiologiques . 8
201.7. 2.17.101  Exigences supplémentaires applicables aux emballages de protection . 8
201.7. 2.101  Exigences supplémentaires applicables au marquage extérieur des
APPAREILS EM ou de leurs parties . 8
201.7. 4.3  Unités de mesure . 9
201.7. 9.1  Exigences générales supplémentaires . 9
201.7. 9.2.1.101  Exigences générales supplémentaires . 10
201.7. 9.2.2.101  Exigences supplémentaires applicables aux avertissements et aux consignes de
sécurité . 10
201.7. 9.2.9.101  Exigences supplémentaires applicables aux instructions de fonctionnement . 11

201.7. 9.2.14.101 Exigences supplémentaires applicables aux ACCESSOIRES, à un appareil
supplémentaire et au matériau utilisé . 11
201.7. 9.3.1.101  Exigences générales supplémentaires . 11
201.8 Protection contre les DANGERS d’origine électrique provenant des APPAREILS EM . 12
201.9 Protection contre les DANGERS d’origine mécanique des APPAREILS EM et des SYSTEMES EM . 12
201.9. 6.2.1.101  Exigences supplémentaires applicables à l’énergie acoustique audible . 12
201.10 Protection contre les DANGERS dus aux rayonnements involontaires ou excessifs . 14
201.11 Protection contre les températures excessives et les autres DANGERS . 14
201.11. 1.2.2  PARTIES APPLIQUEES non destinées à fournir de la chaleur à un PATIENT . 14
201.11. 6.4  Fuite . 14
201.11. 8  Exigences supplémentaires applicables à l’interruption de l’alimentation
électrique/RESEAU D’ALIMENTATION des APPAREILS EM . 15
201.12 Exactitude des commandes et des instruments et protection contre les caractéristiques

de sortie présentant des risques .15

201.12. 1  Exactitude des commandes et des instruments .15

201.12. 1.101  Stabilité de l’EXACTITUDE DE LA PRESSION statique DES VOIES AERIENNES (exactitude

sur le long terme) .15

201.12. 1.102  Stabilité de l’EXACTITUDE DE LA PRESSION dynamique DES VOIES AERIENNES
(exactitude à court terme) .16

201.12. 1.102.1  Mode PPC .16

201.12. 1.102.2   Mode de VENTILATION DES VOIES AERIENNES A DEUX NIVEAUX DE PRESSION .18

201.12. 1.103   Débit maximal .20

201.12. 4   Protection contre les caractéristiques de sortie présentant des risques .21

201.12. 4.101   Mesurage de la PRESSION DES VOIES AERIENNES .21

201.12. 4.102   DISPOSITIF DE PROTECTION DE LA PRESSION MAXIMALE LIMITEE .21
201.12. 4.103   Ré-inhalation de CO .21
201.13 SITUATIONS DANGEREUSES et conditions de défaut .22
201.14 SYSTEMES ELECTROMEDICAUX PROGRAMMABLES (SEMP) .22
201.15 Construction de l'APPAREIL EM .22
201.15. 101  Mode de fonctionnement .22
201.16 SYSTEMES EM .22
201.17 Compatibilité électromagnétique des APPAREILS EM et des SYSTEMES EM .22
201.17. 101  Exigences supplémentaires applicables à la compatibilité électromagnétique des
APPAREILS EM et des SYSTEMES EM .22
201.101 Raccords du CONDUIT DE PASSAGE DU GAZ RESPIRATOIRE .23
201.101. 1  Généralités .23
201.101. 2  Autres orifices nommés .23
201.101. 2.1  ORIFICE DE RACCORDEMENT COTE « PATIENT » .23
201.101. 2.2  ORIFICE DE SORTIE .23
201.101. 2.3  DISPOSITIFS SENSIBLES AU SENS DU DEBIT .23
201.101. 2.4  Orifice auxiliaire .23
201.101. 2.5  Orifice de sonde de surveillance .24
201.102 Exigences applicables au CONDUIT DE PASSAGE DU GAZ RESPIRATOIRE et aux ACCESSOIRES .24
201.102. 1  Généralités .24
201.102. 2  Étiquetage .24
201.102. 3  Humidification .24
201.102. 4  FILTRE POUR SYSTEME RESPIRATOIRE (BSF) .25
201.103 CONNEXION FONCTIONNELLE .25
201.103. 1  Généralités .25
201.103. 2  CONNEXION FONCTIONNELLE prenant en charge le suivi à distance .25
201.104 Formation .25

202  Appareils électromédicaux — Partie 1-2 : Exigences générales pour la sécurité de
base et les performances essentielles — Norme collatérale : Perturbations
électromagnétiques — Exigences et essais .25
202.4.3.1  Configurations .25
202.5.2.2.1  Exigences applicables à tous les APPAREILS EM et SYSTEMES EM .25
202.8.1.101  Exigences générales supplémentaires .26
206  Appareils électromédicaux — Partie 1-6 : Exigences générales pour la sécurité de
base et les performances essentielles — Norme collatérale : Aptitude à l'utilisation .26
208  Appareils électromédicaux — Partie 1-8 : Exigences générales pour la sécurité de
base et les performances essentielles — Norme collatérale : Exigences générales,
essais et guide pour les systèmes d'alarme des appareils et des systèmes
électromédicaux .27
iv © ISO 2015 – All rights reserved

211  Appareils électromédicaux — Partie 1-11 : Exigences générales pour la sécurité de

base et les performances essentielles — Norme collatérale : Exigences pour les

appareils électromédicaux et les systèmes électromédicaux utilisés dans

l'environnement des soins à domicile . 27

ANNEXE C (informative) Guide des exigences de marquage et d'étiquetage pour les APPAREILS EM

et les SYSTEMES EM . 28

Annexe D (informative) Symboles des marquages . 32

Annexe AA (informative) Lignes directrices particulières et justifications . 33

Annexe BB (informative) Exigences applicables à l'interface de données . 38

Annexe CC (informative) Référence aux principes essentiels . 42
Bibliographie . 44
Index alphabétique des termes définis utilisés dans la présente Norme particulière
...