oSIST prEN ISO 80601-2-70:2025

Medical electrical equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (ISO/DIS 80601-2-70:2024)

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].

Medizinische elektrische Geräte - Teil 2-70: Besondere Festlegungen für die Sicherheit und die wesentlichen Leistungsmerkmale von Schlafapnoe-Atemtherapiegeräten (ISO/DIS 80601-2-70:2024)

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/DIS 80601-2-70:2024)

Le présent document s'applique à la sécurité de base et aux performances essentielles des équipements de thérapie respiratoire pour l'apnée du sommeil, désignés ci-après sous le terme d'appareils EM, destinés à soulager les symptômes des patients souffrant d'apnée obstructive du sommeil en délivrant une pression respiratoire à visée thérapeutique dans les voies respiratoires du patient. L'équipement de thérapie respiratoire pour l'apnée du sommeil est destiné à être utilisé dans un environnement de soins à domicile par des opérateurs non spécialistes ainsi que dans des établissements de soins de santé professionnels.
* L'équipement de thérapie respiratoire pour l'apnée du sommeil n'est pas censé utiliser de système physiologique de commande en boucle fermée, sauf s'il utilise une variable physiologique du patient pour ajuster les paramètres de traitement.
Le présent document exclut l'équipement de thérapie respiratoire pour l'apnée du sommeil destiné à une utilisation sur des nouveau-nés.
Le présent document s'applique aux appareils EM ou aux systèmes EM destinés à des patients qui ne sont pas dépendants d'une ventilation mécanique.
Le présent document ne s'applique pas aux appareils EM ni aux systèmes EM destinés à des patients dépendants d'une ventilation mécanique, tels que des patients souffrant d'une apnée centrale du sommeil.
Le présent document s'applique également aux accessoires destinés par leur fabricant à être raccordés à un équipement de thérapie respiratoire pour l'apnée du sommeil, les caractéristiques de ces accessoires pouvant avoir un impact sur la sécurité de base ou sur les performances essentielles de l'équipement de thérapie respiratoire pour l'apnée du sommeil. En outre, les masques et les accessoires d'application destinés à être utilisés au cours de la thérapie respiratoire de l'apnée du sommeil sont aussi traités par l'ISO 17510. Pour connaître les éléments couverts par le présent document, se référer à la Figure AA.1.
Si un article ou un paragraphe est spécifiquement destiné à être appliqué uniquement aux appareils EM ou uniquement aux systèmes EM, le titre et le contenu dudit article ou paragraphe l'indiqueront. Si cela n'est pas le cas, l'article ou le paragraphe s'applique à la fois aux appareils EM et aux systèmes EM, selon le cas.
Les dangers inhérents à la fonction physiologique prévue des appareils EM ou des systèmes EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans le présent document, à l'exception de 7.2.13 et 8.4.1 de la norme générale.
NOTE Voir également le paragraphe 4.2 de la norme générale.
Le présent document ne s'applique pas aux ventilateurs par jet haute fréquence (HFJV), ni aux ventilateurs par oscillation haute fréquence (HFOV), qui sont décrits dans l'ISO 80601-2-87[13].
Le présent document ne définit pas les exigences applicables aux ventilateurs ou aux accessoires destinés aux ventilateurs de soins intensifs pour des patients ventilo-dépendants. Lesdites exigences sont indiquées dans l'ISO 80601‑2‑12.
Le présent document ne définit pas les exigences applicables aux ventilateurs ou aux accessoires destinés aux applications d'anesthésie. Lesdites exigences sont indiquées dans l'ISO 80601-2-13[8].
Le présent document ne définit pas les exigences applicables aux ventilateurs ou aux accessoires destinés à la ventilation à domicile des patients ventilo-dépendants. Lesdites exigences sont indiquées dans l'ISO 80601-

Medicinska električna oprema - 2-70. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za zdravljenje prenehanja dihanja v spanju (ISO/DIS 80601-2-70:2024)

General Information

• Status: Not Published
• Public Enquiry End Date: 27-Feb-2025
• ICS: 11.040.10 - Anaesthetic, respiratory and reanimation equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 06-Jan-2025
• Due Date: 26-May-2025
• Ref Project: prEN ISO 80601-2-70 - Medical electrical equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (ISO/DIS 80601-2-70:2024)

Relations

• Revises: SIST EN ISO 80601-2-70:2021 - 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)
• Effective Date: 07-Jun-2023

Standards Content (Sample)

SLOVENSKI STANDARD
01-februar-2025
Medicinska električna oprema - 2-70. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za zdravljenje prenehanja dihanja v spanju (ISO/DIS
80601-2-70:2024)
Medical electrical equipment - Part 2-70: Particular requirements for basic safety and
essential performance of sleep apnoea breathing therapy equipment (ISO/DIS 80601-2-
70:2024)
Medizinische elektrische Geräte - Teil 2-70: Besondere Festlegungen für die Sicherheit
und die wesentlichen Leistungsmerkmale von Schlafapnoe-Atemtherapiegeräten
(ISO/DIS 80601-2-70:2024)
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/DIS 80601-2-70:2024)
Ta slovenski standard je istoveten z: prEN ISO 80601-2-70
ICS:
11.040.10 Anestezijska, respiratorna in Anaesthetic, respiratory and
reanimacijska oprema reanimation equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 80601-2-70
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-70:
Voting begins on:
Particular requirements for basic 2024-12-30
safety and essential performance
Voting terminates on:
2025-03-24
of sleep apnoea breathing therapy
equipment
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
This document is circulated as received from the committee secretariat. IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This draft is submitted to a parallel vote in ISO and in IEC.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 80601-2-70:2024(en)
DRAFT
ISO/DIS 80601-2-70:2024(en)
International
Standard
ISO/DIS 80601-2-70
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Part 2-70:
Voting begins on:
Particular requirements for basic
safety and essential performance
Voting terminates on:
of sleep apnoea breathing therapy
equipment
ICS: 11.040.10
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
This document is circulated as received from the committee secretariat.
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This draft is submitted to a parallel vote in ISO and in IEC.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: [phone]
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: [e-mail]
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 80601-2-70:2024(en)
ii
ISO/DIS 80601-2-70:2024(E)
1 Contents Page
2 Foreword . vi
3 Introduction . vii
4 201.1 Scope, object and related standards . 1
5 1 Scope . 1
6 2 Object . 2
7 3 Collateral standards . 2
8 4 Particular standards . 2
9 201.2 Normative references . 3
10 201.3 Terms and definitions . 4
11 201.4 General requirements . 18
12 201.4.3 Essential performance . 18
13 201.4.3.101 Additional requirements for essential performance . 18
14 201.4.6 ME equipment or ME system parts that contact the patient . 19
15 201.5 General requirements for testing of ME equipment . 19
16 201.5.101 Additional requirements for general requirements for testing of ME equipment. 19
17 201.5.101.1 Gas flowrate and pressure specifications . 19
18 201.5.101.2 Sleep apnoea breathing therapy equipment testing errors . 19
19 201.6 Classification of ME equipment and ME systems . 20
20 201.7 ME equipment identification, marking and documents . 20
21 201.7.1.2 Legibility of markings . 20
22 201.7.2.4.101 Additional requirements for accessories . 20
23 201.7.2.101 Additional requirements for marking on the outside of ME equipment or
24 ME equipment parts . 21
25 201.7.4.3 Units of measurement . 21
26 201.7.9.2 Instructions for use . 21
27 201.7.9.2.1.101 Additional general requirements . 21
28 201.7.9.2.2.101 Additional requirements for warnings and safety notices . 22
29 201.7.9.2.5.101 Additional requirements for ME equipment description . 22
30 201.7.9.2.9.101 Additional requirements for operating instructions . 22
31 201.7.9.2.12 Cleaning, disinfection, and sterilization. 23
32 201.7.9.2.13.101 Additional requirements for maintenance . 23
33 201.7.9.2.14.101 Additional requirements for accessories, supplementary equipment,
34 used material . 23
35 201.7.9.3.1.101 Additional general requirements . 24
36 201.8 Protection against electrical hazards from ME equipment . 25
37 201.9 Protection against mechanical hazards of ME equipment and ME systems . 25
38 201.9.6.2.1.101 Additional requirements for audible acoustic energy . 25
39 201.10 Protection against unwanted and excessive radiation hazards . 27
40 201.11 Protection against excessive temperatures and other hazards . 27
41 201.11.1.2.2 Applied parts not intended to supply heat to a patient . 27
42 201.11.6.6 Cleaning and disinfection of ME equipment or ME system . 27
43 201.11.7 Biocompatibility of ME equipment and ME systems . 28
44 201.11.8 Additional requirements for interruption of the power supply/supply mains to
45 ME equipment . 28
iii
ISO/DIS 80601-2-70:2024(E)
46 201.12 Accuracy of controls and instruments and protection against hazardous outputs . 29
47 201.12.1 Accuracy of controls and instruments . 29
48 201.12.1.101 Stability of static airway pressure accuracy (long-term accuracy). 29
49 201.12.1.102 Stability of dynamic airway pressure accuracy (short-term accuracy) . 30
50 201.12.1.102.1 CPAP mode . 30
51 201.12.1.102.2 Bi-level positive airway pressure mode, pressure stability . 32
52 201.12.1.103 Maximum flowrate . 35
53 201.12.4 Protection against hazardous output . 38
54 201.12.4.101 Measurement of airway pressure . 38
55 201.12.4.102 Maximum limited pressure protection device . 38
56 201.12.4.103 CO rebreathing . 39
57 201.13 Hazardous situations and fault conditions . 39
58 201.14 Programmable electrical medical systems (PEMS) . 39
59 201.15 Construction of ME equipment . 40
60 201.15.101 Mode of operation . 40
61 201.16 ME systems . 40
62 201.17 Electromagnetic compatibility of ME equipment and ME systems . 40
63 201.101 Breathing gas pathway connectors . 40
64 1 General . 40
65 2 Other named ports . 41
66 2.1 Patient-connection port . 41
67 2.2 Gas output port . 41
68 2.3 Flow-direction-sensitive components . 41
69 2.4 Gas pathway connection port . 41
70 2.5 Monitoring probe port .
...