SIST EN ISO 80601-2-70:2026
(Main)Medical electrical equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (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 80601-2-70:2025)
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 artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on artificial 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 2 See also 4.2 of the general standard.
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.
– ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13.
– ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72.
– ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84.
– ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601‑2-79 and ISO 80601‑2‑80.
– high-frequency ventilators[23], which are given in ISO 80601-2-87.
– respiratory high flow equipment, which are given in ISO 80601‑2‑90;
NOTE 3 ISO 80601-2-80 ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients.
– user-powered resuscitators, which are given in ISO 10651-4;
– gas-powered emergency resuscitators, which are given in ISO 10651-5;
– oxygen therapy constant flow ME equipment; and
– cuirass or “iron-lung” ventilation equipment.
Medizinische elektrische Geräte - Teil 2-70: Besondere Festlegungen für die Sicherheit und die wesentlichen Leistungsmerkmale von Schlafapnoe-Atemtherapiegeräten (ISO 80601-2-70:2025)
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 80601-2-70:2025)
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 artificielle. Le présent document ne s'applique pas aux appareils EM ni aux systèmes EM destinés à des patients dépendants d'une ventilation artificielle, 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 2 Voir également le paragraphe 4.2 de la norme générale.
Le présent document ne spécifie 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;
— aux ventilateurs ou aux accessoires destinés aux applications d'anesthésie. Lesdites exigences sont indiquées dans l'ISO 80601-2-13;
— aux ventilateurs ou aux accessoires destinés à la ventilation à domicile des patients ventilo‑dépendants. Lesdites exigences sont indiquées dans l'ISO 80601-2-72;
— aux ventilateurs ou accessoires de secours et de transport. Lesdites exigences sont indiquées dans l'ISO 80601‑2‑84;
— aux ventilateurs ou aux accessoires destinés aux dispositifs d'assistance respiratoire à domicile. Lesdites exigences sont indiquées dans l'ISO 80601‑2-79 et l
Medicinska električna oprema - 2-70. del: Posebne zahteve za osnovno varnost in bistvene lastnosti opreme za zdravljenje prenehanja dihanja v spanju (ISO 80601-2-70:2025)
General Information
- Status
- Published
- Public Enquiry End Date
- 27-Feb-2025
- Publication Date
- 16-Dec-2025
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 12-Dec-2025
- Due Date
- 16-Feb-2026
- Completion Date
- 17-Dec-2025
Relations
- Effective Date
- 01-Feb-2026
Overview
EN ISO 80601-2-70:2025 - Medical electrical equipment - Part 2-70 - specifies particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment (often used for CPAP and bi‑level therapy). Published by CEN as the European adoption of ISO 80601-2-70:2025, this standard applies to medical electrical (ME) equipment and ME systems intended to relieve obstructive sleep apnoea by delivering therapeutic breathing pressure in both home healthcare and professional settings. It excludes neonatal devices and equipment intended for ventilator‑dependent patients and other specialised ventilators covered by separate standards.
Key topics and technical requirements
The standard addresses a broad range of safety, performance and usability requirements, including:
Essential performance and accuracy
- Stability of static and dynamic airway pressure (long‑term and short‑term accuracy)
- Specific requirements for CPAP and bi‑level operational modes
- Maximum flowrate and measurement of airway pressure
- Protection against hazardous outputs (maximum pressure limits, CO rebreathing)
General safety and construction
- Electrical, mechanical and thermal safety for ME equipment and systems
- Biocompatibility and cleaning, disinfection and sterilization requirements
- Labelling, identification, instructions for use, warnings and maintenance information
Breathing gas pathway and connectors
- Patient‑connection and gas output ports, oxygen inlet (low and high pressure), flow‑direction components
- Humidification and breathing system filter (BSF) considerations
- Requirements for accessories whose characteristics affect safety or performance
Systems engineering and interoperability
- Programmable electrical medical systems (PEMS)
- Functional connections (including remote supervision)
- Electromagnetic compatibility (EMC) and usability testing
Practical applications and users
EN ISO 80601-2-70:2025 is essential for:
- Manufacturers designing, testing and certifying CPAP and bi‑level sleep apnoea devices and related accessories
- Test laboratories performing performance verification and compliance testing
- Regulatory authorities and conformity assessment bodies evaluating safety and essential performance
- Clinical engineers, procurement teams and healthcare providers specifying safe, interoperable devices for home or institutional use
- Designers of accessories (masks, tubing, filters) where accessory characteristics affect ME equipment performance
Related standards
- ISO 17510 (masks and application accessories)
- ISO 80601 series (ventilator‑related parts: -2-12, -2-13, -2-72, -2-79, -2-80, -2-84, -2-87, -2-90)
- ISO 10651 series (resuscitators)
This standard helps ensure sleep apnoea therapy devices meet robust safety, accuracy and usability criteria for effective and reliable patient therapy in home and clinical environments.
Frequently Asked Questions
SIST EN ISO 80601-2-70:2026 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Medical electrical equipment - Part 2-70: Particular requirements for basic safety and essential performance of sleep apnoea breathing therapy equipment (ISO 80601-2-70:2025)". This standard covers: 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 artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on artificial 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 2 See also 4.2 of the general standard. 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. – ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13. – ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72. – ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84. – ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601‑2-79 and ISO 80601‑2‑80. – high-frequency ventilators[23], which are given in ISO 80601-2-87. – respiratory high flow equipment, which are given in ISO 80601‑2‑90; NOTE 3 ISO 80601-2-80 ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients. – user-powered resuscitators, which are given in ISO 10651-4; – gas-powered emergency resuscitators, which are given in ISO 10651-5; – oxygen therapy constant flow ME equipment; and – cuirass or “iron-lung” ventilation 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 artificial ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on artificial 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 2 See also 4.2 of the general standard. 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. – ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13. – ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72. – ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84. – ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601‑2-79 and ISO 80601‑2‑80. – high-frequency ventilators[23], which are given in ISO 80601-2-87. – respiratory high flow equipment, which are given in ISO 80601‑2‑90; NOTE 3 ISO 80601-2-80 ventilatory support equipment can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients. – user-powered resuscitators, which are given in ISO 10651-4; – gas-powered emergency resuscitators, which are given in ISO 10651-5; – oxygen therapy constant flow ME equipment; and – cuirass or “iron-lung” ventilation equipment.
SIST EN ISO 80601-2-70:2026 is classified under the following ICS (International Classification for Standards) categories: 11.040.10 - Anaesthetic, respiratory and reanimation equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN ISO 80601-2-70:2026 has the following relationships with other standards: It is inter standard links to SIST EN ISO 80601-2-70:2021. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase SIST EN ISO 80601-2-70:2026 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2026
Nadomešča:
SIST EN ISO 80601-2-70:2021
Medicinska električna oprema - 2-70. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti opreme za zdravljenje prenehanja dihanja v spanju (ISO 80601-2
-70:2025)
Medical electrical equipment - Part 2-70: Particular requirements for basic safety and
essential performance of sleep apnoea breathing therapy equipment (ISO 80601-2-
70:2025)
Medizinische elektrische Geräte - Teil 2-70: Besondere Festlegungen für die Sicherheit
und die wesentlichen Leistungsmerkmale von Schlafapnoe-Atemtherapiegeräten (ISO
80601-2-70:2025)
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 80601-2-70:2025)
Ta slovenski standard je istoveten z: EN ISO 80601-2-70:2025
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.
EN ISO 80601-2-70
EUROPEAN STANDARD
NORME EUROPÉENNE
December 2025
EUROPÄISCHE NORM
ICS 11.040.10 Supersedes EN ISO 80601-2-70:2020
English Version
Medical electrical equipment - Part 2-70: Particular
requirements for basic safety and essential performance of
sleep apnoea breathing therapy equipment (ISO 80601-2-
70:2025)
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 80601-2-70:2025)
70:2025)
This European Standard was approved by CEN on 23 November 2025.
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, Türkiye 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
© 2025 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 80601-2-70:2025 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 80601-2-70:2025) 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 June 2026, and conflicting national standards shall be
withdrawn at the latest by June 2026.
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 80601-2-70:2020.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 80601-2-70:2025 has been approved by CEN as EN ISO 80601-2-70:2025 without any
modification.
International
Standard
ISO 80601-2-70
Third edition
Medical electrical equipment —
2025-11
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 80601-2-70:2025(en) © ISO 2025
ISO 80601-2-70:2025(en)
© ISO 2025
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 80601-2-70:2025(en)
Contents Page
Foreword . vi
Introduction . vii
201.1 Scope, object and related standards . 1
1 Scope . 1
2 Object . 2
3 Collateral standards . 2
4 Particular standards . 3
201.2 Normative references . 4
201.3 Terms and definitions . 5
201.4 General requirements . 20
201.4.3 Essential performance . 20
201.4.3.101 Additional requirements for essential performance . 20
201.4.6 ME equipment or ME system parts that contact the patient . 21
201.5 General requirements for testing of ME equipment . 21
201.5.101 Additional requirements for general requirements for testing of ME equipment . 21
201.5.101.1 Gas flowrate specifications . 21
201.5.101.2 Sleep apnoea breathing therapy equipment testing errors . 21
201.6 Classification of ME equipment and ME systems . 22
201.7 ME equipment identification, marking and documents. 22
201.7.1.2 Legibility of markings . 22
201.7.2.4.101 Additional requirements for accessories . 22
201.7.2.101 Additional requirements for marking on the outside of ME equipment or
ME equipment parts . 23
201.7.4.3 Units of measurement . 23
201.7.9.2 Instructions for use . 23
201.7.9.2.1.101 Additional general requirements . 24
201.7.9.2.2.101 Additional requirements for warnings and safety notices . 24
201.7.9.2.5.101 Additional requirements for ME equipment description . 25
201.7.9.2.9.101 Additional requirements for operating instructions . 25
201.7.9.2.12 Cleaning, disinfection, and sterilization . 25
201.7.9.2.13.101 Additional requirements for maintenance . 25
201.7.9.2.14.101 Additional requirements for accessories, supplementary
equipment, used material . 26
201.7.9.3.1.101 Additional general requirements . 26
201.8 Protection against electrical hazards from ME equipment . 27
201.9 Protection against mechanical hazards of ME equipment and ME systems . 27
201.9.6.2.1.101 Additional requirements for audible acoustic energy . 28
201.10 Protection against unwanted and excessive radiation hazards . 30
201.11 Protection against excessive temperatures and other hazards . 30
201.11.1.2.2 Applied parts not intended to supply heat to a patient . 30
201.11.6.6 Cleaning and disinfection of ME equipment or ME system . 30
iii
ISO 80601-2-70:2025(en)
201.11.7 Biocompatibility of ME equipment and ME systems . 31
201.11.8 Additional requirements for interruption of the power supply/supply mains to
ME equipment . 32
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 32
201.12.1 Accuracy of controls and instruments . 32
201.12.1.101 Stability of static airway pressure accuracy (long-term accuracy) . 32
201.12.1.102 Stability of dynamic airway pressure accuracy (short-term accuracy) . 34
201.12.1.102.1 CPAP mode . 34
201.12.1.102.2 Bi-level positive airway pressure mode, pressure stability . 35
201.12.1.103 Maximum flowrate . 38
201.12.4 Protection against hazardous output . 41
201.12.4.101 Measurement of airway pressure . 41
201.12.4.102 Maximum limited pressure protection device . 41
201.12.4.103 CO rebreathing . 42
201.13 Hazardous situations and fault conditions . 42
201.14 Programmable electrical medical systems (PEMS) . 42
201.15 Construction of ME equipment . 43
201.15.101 Mode of operation . 43
201.16 ME systems . 43
201.17 Electromagnetic compatibility of ME equipment and ME systems . 43
201.101 Breathing gas pathway connectors . 44
1 General . 44
2 Other named ports . 44
2.1 Patient-connection port . 44
2.2 Gas output port . 44
2.3 Flow-direction-sensitive components. 45
2.4 Accessory access connection port . 45
2.5 Oxygen inlet connector . 45
201.101.2.5.1 Low pressure . 45
201.101.2.5.2 High pressure . 46
201.102 Requirements for the breathing gas pathway and accessories . 46
1 General . 46
2 Labelling . 46
3 Humidification . 47
4 Breathing system filter (BSF) . 47
201.103 Functional connection. 47
1 General . 47
2 Functional connection to support remote supervision . 47
202 Electromagnetic disturbances — Requirements and tests . 48
202.4.3.1 Configurations . 48
202.5.2.2.1 Requirements applicable to all ME equipment and ME systems . 48
202.8.1.101 Additional general requirements . 48
206 Usability . 48
iv
ISO 80601-2-70:2025(en)
211 Requirements for medical electrical equipment and medical electrical
systems used in the home healthcare environment . 49
211.4.2.3.1 Continuous operating conditions . 49
Annex C (informative) Guide to marking and labelling requirements for
ME equipment and ME systems . 50
201.C.1 Marking on the outside of ME equipment, ME systems or their parts . 50
201.C.2 Accompanying documents, general . 50
201.C.3 Accompanying documents, instructions for use . 51
201.C.4 Accompanying documents, technical description . 53
Annex AA (informative) Particular guidance and rationale . 55
AA.1 General guidance . 55
AA.2 Rationale for particular clauses and subclauses . 56
AA.2.1 — 201.1.1 — Scope . 56
AA.2.2 — 201.3.207 — Auto CPAP . 57
AA.2.3 — 201.3.208 — Automatic start/stop function . 58
AA.2.4 — 201.3.254 — Ramp mode . 58
AA.2.5 — 201.4.3.101 — Additional requirements for essential performance . 58
AA.2.6 — 201.4.6 — ME equipment or ME system parts that contact the patient . 59
AA.2.7 — 201.5.101.2 — Sleep apnoea breathing therapy equipment testing errors . 59
AA.2.8 — 201.7.1.2 — Legibility of markings. 59
AA.2.9 — 201.7.9.3.1.101 — Additional general requirements . 59
AA.2.10 — 201.9.6.2.1.101 — Additional requirements for audible acoustic energy . 60
AA.2.11 — 201.11.6 — Cleaning and disinfection of ME equipment or ME system . 60
AA.2.12 — 201.12.1 — Accuracy of controls and instruments . 63
AA.2.13 — 201.12.1.102.2 — Bi-level positive airway pressure mode, pressure stability . 63
AA.2.14 — 201.12.1.103 — Maximum flowrate . 63
— c) 2) 63
AA.2.15 — 201.12.4.102 — Maximum limited pressure protection device . 63
Annex BB (informative) Data interface requirements . 65
BB.1 Background and purpose . 65
BB.2 Data definition . 66
Annex CC (informative) Reference to the IMDRF essential principles and
labelling guidances . 69
Annex DD (informative) Terminology — alphabetized index of defined terms . 73
Bibliography . 77
v
ISO 80601-2-70:2025(en)
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, Medical equipment, software, and systems, Subcommittee SC D, Particular
medical equipment, software, and systems, 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 third edition cancels and replaces the second edition (ISO 80601-2-70:2020), which has been
technically revised.
The main changes compared to the previous edition are as follows:
— updated references;
— updated the audible acoustic energy requirements; and
— updated the maximum flowrate test method.
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 80601-2-70:2025(en)
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, heart
[25]
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. Hypopnoea is less
[23]
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
— 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.
vii
ISO 80601-2-70:2025(en)
For the purposes of this document, the auxiliary verb:
– “shall” indicates a requirement;
– “should” indicates a recommendation;
– “may” indicates a permission;
– "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.
viii
INTERNATIONAL STANDARD ISO 80601-2-70:2025(en)
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.
1 Scope
NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2.1.
IEC 60601-1:2005+AMD1:2012+AMD2:2020, 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 artificial ventilation. This document is not applicable to ME equipment or an ME system
intended for those patients who are dependent on artificial 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 80601-2-70:2025(en)
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 2 See also 4.2 of the general standard.
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.
– ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13.
– ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are
given in ISO 80601-2-72.
– ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84.
– ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601-2-79
and ISO 80601-2-80.
[23]
– high-frequency ventilators , which are given in ISO 80601-2-87.
– respiratory high flow equipment, which are given in ISO 80601-2-90;
NOTE 3 ISO 80601-2-80 ventilatory support equipment can incorporate high-flow therapy operational mode,
but such a mode is only for spontaneously breathing patients.
– user-powered resuscitators, which are given in ISO 10651-4;
– gas-powered emergency resuscitators, which are given in ISO 10651-5;
– oxygen therapy constant flow ME equipment; and
– cuirass or “iron-lung” ventilation equipment.
2 Object
IEC 60601-1:2005+AMD1:2012+AMD2:2020, 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 201.3.259).
[20] [21]
NOTE 1 This document has been prepared to address the relevant essential principles and labelling principles 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 general safety and performance requirements of
[19]
European regulation (EU) 2017/745 .
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, 206 and 211 respectively. IEC 60601-1-3 and IEC 60601-1-9 do not apply. All other published
collateral standards in the IEC 60601-1 series apply as published.
ISO 80601-2-70:2025(en)
4 Particular standards
Replacement:
In the IEC 60601 series, particular standards specify 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 standard, e.g. 202 for IEC 60601-1-2, 211 for IEC 60601-
1-11, etc.
The term "this document" is used to make reference to the general standard, any applicable collateral
standards and this document taken together.
Where there is no corresponding clause or subclause in this document, the clause or subclause of the general
standard or applicable collateral standard, although possibly not relevant, applies without modification;
where it is intended that any part of the general standard or applicable collateral standard, although possibly
relevant, is not to be applied, a statement to that effect is given in this document.
ISO 80601-2-70:2025(en)
201.2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 2 applies, except as follows:
Addition:
ISO 3744:2010, Acoustics — Determination of sound power levels and sound energy levels of noise sources
using sound pressure — Engineering methods for an essentially free field over a reflecting plane
ISO 4871:1996, Acoustics — Declaration and verification of noise emission values of machinery and equipment
ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Cones and sockets
ISO 14937:2009, Sterilization of health care products — General requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization process for medical
devices
ISO 17510:— , Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
ISO 17664-1:2021, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices
ISO 17664-2:2021, Processing of health care products — Information to be provided by the medical device
manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
ISO 18562-1:2024, Biocompatibility evaluation of breathing gas pathways in healthcare applications — Part
1: Evaluation and testing within a risk management process
ISO 20417:— , Medical devices — Information to be supplied by the manufacturer
ISO 23328-1:2003, Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to
assess filtration performance
ISO 23328-2:2002, Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration
aspects
ISO 80369-1:2025, Small-bore connectors for liquids and gases in healthcare applications — Part 1: General
requirements
ISO 80369-7:2021, Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors
for intravascular or hypodermic applications
ISO 80601-2-74:— , Medical electrical equipment — Part 2-74: Particular requirements for basic safety and
essential performance of respiratory humidifying equipment
Under preparation. Stage at the time of publication: ISO/FDIS 17510:2025.
Under preparation. Stage at the time of publication: ISO/FDIS 20417:2025.
ISO 80601-2-70:2025(en)
IEC Guide 115:2023, Application of uncertainty of measurement to conformity assessment activities in the
electrotechnical sector
201.3 Terms and definitions
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005+AMD1:2012+AMD2:2020, and the following apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp
— IEC Electropedia: available at http://www.electropedia.org/
Addition:
201.3.201
accompanying information
information accompanying or marked on a medical device or accessory for the user or those accountable for
the installation, use, processing, maintenance, decommissioning and disposal of the medical device or
accessory, particularly regarding safe use
Note 1 to entry: The accompanying information shall be regarded as part of the medical device or accessory.
Note 2 to entry: The accompanying information can consist of the label, marking, instructions for use, technical
description, installation manual, quick reference guide, etc.
Note 3 to entry: Accompanying information is not necessarily a written or printed document but could involve auditory,
visual, or tactile materials and multiple media types (e.g. CD/DVD-ROM, USB stick, website).
[SOURCE: ISO 20417:—, 3.2, modified — deleted note 4.]
201.3.202
airway
connected, gas-containing cavities and passages within the respiratory system, that conduct gas between the
alveoli and the oral and nasal orifices on the surface of the face, or the patient-connection port if an airway
device is used
Note 1 to entry: This is a well-established term that is commonly used in isolation in references to the airway of a
patient. Depending on the context, it is sometimes more helpful to use the qualified term, patient's airway.
[SOURCE: ISO 19223:2019, 3.1.2, modified — deleted note 2.]
Under preparation. Stage at the time of publication: ISO/FDIS 80601-2-74:2025.
ISO 80601-2-70:2025(en)
201.3.203
airway pressure
p
aw
pressure at the patient-connection port or at the distal outlet of the equipment where there is no patient-
connection port
Note 1 to entry: The airway pressure can be derived from pressure measurements made anywhere within the
equipment.
[SOURCE: ISO 4135:2022, 3.1.4.41.1, modified — added letter symbol.]
201.3.204
airway
...
Die Norm SIST EN ISO 80601-2-70:2026 bietet umfassende Anforderungen an die grundlegende Sicherheit und die essentielle Leistung von Geräten zur Atemtherapie bei Schlafapnoe. Der Geltungsbereich dieser Norm ist präzise definiert und konzentriert sich auf medizinische elektrische Geräte, die dazu dienen, die Symptome von Patienten mit obstruktiver Schlafapnoe zu lindern, indem sie einen therapeutischen Atemdruck in die Atemwege der Patienten liefern. Diese Geräte sind sowohl für den Einsatz durch Laien im häuslichen Gesundheitswesen als auch für Fachkräfte in Gesundheitseinrichtungen vorgesehen, was ihre Relevanz in verschiedenen Anwendungsszenarien erheblich erhöht. Ein herausragendes Merkmal der Norm ist ihre detaillierte Handhabung der grundlegenden Sicherheitsanforderungen für Geräte der Atemtherapie. Sie stellt sicher, dass die Benutzer sowohl im häuslichen als auch im professionellen Bereich auf eine sichere Nutzung der Geräte vertrauen können. Die Norm schließt Geräte für Neugeborene aus, was einen klaren Fokus auf die Zielgruppe ermöglicht und sicherstellt, dass die Anforderungen spezifisch auf die Bedürfnisse von Erwachsenen zugeschnitten sind, die nicht auf künstliche Beatmung angewiesen sind. Eine weitere Stärke der Norm liegt in der Berücksichtigung von Zubehörteilen, die vom Hersteller mit den Geräten zur Atemtherapie verbunden werden, sowie deren Auswirkungen auf die Sicherheit und Leistung des Hauptgeräts. Dies fördert nicht nur ein besseres Verständnis der gesamten Systemintegrität, sondern auch die Sicherheit der Anwendung insgesamt. Die klare Differenzierung in den spezifischen Anforderungen, sei es für ME-Geräte oder ME-Systeme, und die explizite Nennung, wenn bestimmte Klauseln ausschließlich für einen der beiden Anlagetypen gelten, gewährleistet eine klare und präzise Kommunikation der Anforderungen. Die Norm verweist auch auf andere ISO-Normen, die in unterschiedlichen Kontexten Anwendung finden, wodurch sie die Vielfalt der verfügbaren Technologien in der Atemtherapie adressiert. Zusammenfassend lässt sich sagen, dass die Norm SIST EN ISO 80601-2-70:2026 sowohl in ihren Sicherheitsanforderungen als auch in ihrer Anwendbarkeit einen unverzichtbaren Beitrag zur Verbesserung der Versorgung von Patienten mit Schlafapnoe leistet und somit ihre große Bedeutung für die praktische Anwendung in der medizinischen Versorgung unterstreicht.
The standard SIST EN ISO 80601-2-70:2026 serves as a comprehensive guideline specifically aimed at the basic safety and essential performance of sleep apnoea breathing therapy equipment, referred to as ME equipment. It is vital for mitigating the symptoms of obstructive sleep apnoea by delivering therapeutic breathing pressure to the respiratory tract, thus significantly benefiting patients in both home healthcare settings and professional healthcare institutions. One of the notable strengths of this standard is its clear delineation of applicability, ensuring that it targets only the intended ME equipment used by patients who are not dependent on artificial ventilation. This focus eliminates ambiguity regarding the devices covered, reinforcing safety and performance standards relevant to the specific types of equipment utilized for sleep apnoea therapy. Additionally, the exclusion of equipment for neonates underscores the standard's consideration for different patient demographics, ensuring that it is tailored to the needs of adult patients primarily. Moreover, the standard recognizes the importance of accessories connected to the sleep apnoea breathing therapy equipment. By incorporating requirements for these accessories, the document ensures that they do not compromise the basic safety or essential performance of the primary ME equipment. This inclusion is critical as it addresses the comprehensive functioning of the therapy setup, promoting a holistic approach to patient care. Furthermore, SIST EN ISO 80601-2-70:2026 provides a structured framework for understanding where specific clauses apply uniquely to ME equipment versus ME systems, enhancing clarity for manufacturers and operators alike. This specificity allows users to navigate the requirements more effectively, fostering compliance and better safety oversight. Despite its thoroughness, the standard adeptly clarifies what it does not cover, such as ventilators for critical care or transport, thereby preventing the misapplication of its guidelines to equipment outside its intended scope. This cautious delineation helps manufacturers and healthcare providers focus on adhering to the relevant standards without confusion. Overall, the SIST EN ISO 80601-2-70:2026 standard plays a pivotal role in ensuring the safety and efficacy of sleep apnoea breathing therapy equipment, ultimately contributing to improved patient outcomes. Its precise scope, strengths in inclusive accessory considerations, and clear applicability make it an essential resource for stakeholders in the healthcare industry focused on sleep-related breathing disorders.
SIST EN ISO 80601-2-70:2026は、睡眠時無呼吸症候群治療機器の基本的な安全性と重要な性能に関する特定要件を定めた重要な文書です。この規格は、閉塞性睡眠時無呼吸の症状を軽減するために、患者の呼吸器系に治療的な呼吸圧を供給することを目的とした医療電気機器（ME機器）に適用されます。 この規格の強みは、安定した設計基準を提供することで、医療従事者や一般の操作者が自宅や医療機関で使用する際の安全性を高める点にあります。具体的には、通常の運用環境下でのリスクを評価し、基本的な安全性を確保するための要求事項が含まれています。また、自律呼吸を行う患者を対象とするため、人工換気に依存する患者に関する機器には適用されないことを明示することで、対象範囲を明確にしています。これにより、使用者は適切な医療機器を選択でき、患者の治療に関する信頼性が向上します。 さらに、この文書は、睡眠時無呼吸治療機器に接続される付属品についても言及しており、これにより、付属品が安全性や性能に与える影響を評価することが求められます。また、ISO 17510によるマスクやアプリケーションアクセサリーについての指針も提示されており、治療の全体的な品質向上に寄与しています。 この規格は、医療機器やMEシステムにおける品質基準を確立し、睡眠時無呼吸症患者に対する効果的な治療の実現に資するものであり、その重要性は計り知れません。睡眠時無呼吸治療に関する専門的な知識と基準を提供することで、患者の生活の質を向上させるための重要な基盤となっています。
La norme SIST EN ISO 80601-2-70:2026 est un document fondamental qui traitent des exigences particulières applicables à l'équipement de thérapie respiratoire pour l'apnée du sommeil. Son champ d'application est clairement défini : il s'applique à la sécurité de base et à la performance essentielle des équipements de thérapie respiratoire destinés à traiter les symptômes des patients souffrant d'apnée obstructive du sommeil en livrant une pression respiratoire thérapeutique. Une force majeure de cette norme réside dans son approche adaptative, car elle s'adresse aussi bien aux utilisateurs profanes en environnement de soins à domicile qu'aux institutions de santé professionnelles. Cela permet une meilleure accessibilité de la thérapie pour un large éventail de patients, y compris ceux qui ne dépendent pas de la ventilation artificielle. La norme stipule des exclusions précises, renforçant ainsi la clarté de son application. Par exemple, l'équipement destiné aux nouveau-nés ainsi que ceux utilisés pour des patients dépendants de la ventilation artificielle sont explicitement exclus, ce qui contribue à éviter les ambiguïtés lors de la mise en œuvre des exigences. Ce point renforce la pertinence de la norme dans le cadre des soins aux adultes et simplifie la compréhension des utilisateurs. Un autre aspect notable est l'accent mis sur les accessoires qui peuvent influencer la sécurité ou la performance essentielle de l'équipement de thérapie respiratoire. Cela garantit que les utilisateurs prennent en compte non seulement l'équipement principal, mais aussi les éléments complémentaires, ce qui est crucial pour la sécurité et l'efficacité du traitement. Enfin, la norme prévoit des évaluations des risques inhérents à la fonction physiologique de l'équipement, indiquant un souci de sécurité qui est essentiel dans le domaine des soins de santé. Cette analyse des risques, bien que limitée, démontre une compréhension profonde des dangers potentiels pouvant découler de l'utilisation de tels dispositifs. Dans l'ensemble, la SIST EN ISO 80601-2-70:2026 s'affirme comme un standard essentiel pour les équipements de thérapie respiratoire contre l'apnée du sommeil, offrant des directives claires et pertinentes qui garantissent la sécurité et l'efficacité des traitements dans un cadre adapté, tout en restant exclusif et précis pour des situations bien définies.
SIST EN ISO 80601-2-70:2026 표준은 수면 무호흡 치료 장비의 기본 안전성과 필수 성능에 대한 구체적인 요구 사항을 정립하고 있습니다. 이 문서는 기계적 장비(ME equipment)가 수면 무호흡증 환자의 증상을 완화하기 위해 치료 호흡 압력을 호흡기로 전달하는 데 필수적인 요구 사항을 포함하고 있습니다. 이 표준의 범위는 가정 및 전문 의료 기관에서 사용되는 수면 무호흡 치료 장비에 적용됩니다. 이는 특히 비호흡 환자를 위한 ME 장비에 중점을 두며, 인공 환기 의존 환자에게 사용되는 장비에는 적용되지 않습니다. 이러한 제한적인 적용 범위는 관련 사용자와 의료 제공자가 안전하고 효과적인 장비를 선택하는 데 도움을 줍니다. SIST EN ISO 80601-2-70:2026의 강점 중 하나는 장비의 기초 안전성과 성능에 대한 명확한 요구 사항을 제공한다는 점입니다. 이러한 명확한 지침은 치료 장비가 사용될 환경에서의 안전성을 높이며, 장비의 특성이 치료 성능에 미치는 영향을 고려하고 있습니다. 또한 이 표준은 장비와 연결되는 액세서리의 기본 안전성도 고려하므로, 전체 시스템의 안전성을 향상시키는 효과를 가지고 있습니다. 특히, 이 문서는 수면 무호흡 치료에 사용되는 마스크 및 적용 액세서리에 대한 요구 사항을 ISO 17510과 연계하여 다루고 있어, 이와 관련된 장비와의 호환성 및 안전성을 높이는 데 기여하고 있습니다. 또한 생리학적 제어 루프 시스템을 명시적으로 요구하지 않음으로써, 다양한 설계의 장비들이 이 표준을 충족할 수 있게 하여 보다 폭넓은 선택지를 제공합니다. 결론적으로, SIST EN ISO 80601-2-70:2026은 수면 무호흡 치료 장비의 안전성과 성능에 대한 중요한 기준을 설정하고 있으며, 의료 환경에서의 신뢰성을 보장하고患者의 치료 효과를 극대화하는 데 중요한 역할을 합니다. 이 표준은 수면 무호흡증 환자를 위한 치료 장비의 설계 및 사용에 필수적인 참조 문서로 자리 잡고 있습니다.
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