ISO 80601-2-70:2020
(Main)Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions. * Sleep apnoea breathing therapy equipment is not considered to utilize a physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings. This document excludes sleep apnoea breathing therapy equipment intended for use with neonates. This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on mechanical ventilation. This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on mechanical ventilation such as patients with central sleep apnoea. This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment. Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. NOTE See also 4.2 of the general standard. This document is not applicable to high-frequency jet ventilators (HFJVs) or high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601-2-87[13]. This document does not specify the requirements for ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, which are given in ISO 80601‑2‑12. This document does not specify the requirements for ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13[8]. This document does not specify the requirements for ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72[9]. This document does not specify the requirements for ventilators or accessories intended for emergency and transport, which are given in ISO 80601-2-84[12]. This document does not specify the requirements for ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601-2-79[10] and ISO 80601‑2‑80[11].
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 80601-2-70
Second edition
2020-11
Medical electrical equipment —
Part 2-70:
Particular requirements for the basic
safety and essential performance
of sleep apnoea breathing therapy
equipment
Appareils électromédicaux —
Partie 2-70: Exigences particulières pour la sécurité de base et les
performances essentielles de l'équipement de thérapie respiratoire
pour l'apnée du sommeil
Reference number
©
ISO 2020
© ISO 2020
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Published in Switzerland
ii © ISO 2020 – All rights reserved
Contents Page
Foreword . vi
Introduction . vii
201.1 * Scope, object and related standards . 1
201.1.1 Scope . 1
201.1.2 Object . 2
201.1.3 Collateral standards . 2
201.1.4 Particular standards . 2
201.2 Normative references . 3
201.3 Terms and definitions . 4
201.4 General requirements . 7
201.4.3 Essential performance . 7
201.4.3.101 * Additional requirements for essential performance. 7
201.4.6 * ME equipment or ME system parts that contact the patient . 7
201.5 General requirements for testing of ME equipment . 8
201.5.101 Additional requirements for general requirements for testing of
ME equipment. 8
201.5.101.1 Gas flowrate and pressure specifications . 8
201.5.101.2 * Sleep apnoea breathing therapy equipment testing errors . 8
201.6 Classification of ME equipment and ME systems . 8
201.7 ME equipment identification, marking and documents . 8
201.7.1.2 * Legibility of markings . 8
201.7.2.4.101 Additional requirements for accessories . 9
201.7.2.13.101 Additional requirements for physiological effects . 9
201.7.2.17.101 * Additional requirements for protective packaging . 9
201.7.2.101 Additional requirements for marking on the outside of ME equipment or
ME equipment parts . 10
201.7.4.3 Units of measurement . 10
201.7.9.1 * Additional general requirements . 10
201.7.9.2 Instructions for use . 11
201.7.9.2.1.101 Additional general requirements . 11
201.7.9.2.2.101 Additional requirements for warnings and safety notices . 11
201.7.9.2.5.101 Additional requirements for ME equipment description . 12
201.7.9.2.9.101 Additional requirements for operating instructions . 12
201.7.9.2.12 Cleaning, disinfection, and sterilization . 12
201.7.9.2.14.101 Additional requirements for accessories, supplementary
equipment, used material . 13
201.7.9.3.1.101 * Additional general requirements . 13
201.8 Protection against electrical hazards from ME equipment . 14
201.9 Protection against mechanical hazards of ME equipment and ME systems . 14
201.9.6.2.1.101 * Additional requirements for audible acoustic energy . 14
201.10 Protection against unwanted and excessive radiation hazards . 16
201.11 Protection against excessive temperatures and other hazards . 16
201.11.1.2.2 Applied parts not intended to supply heat to a patient . 16
© ISO 2020 – All rights reserved iii
201.11.6.6 * Cleaning and disinfection of ME equipment or ME system . 17
201.11.7 Biocompatibility of ME equipment and ME systems . 17
201.11.8 Additional requirements for interruption of the power supply/supply mains
to ME equipment . 18
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 18
201.12.1 * Accuracy of controls and instruments . 18
201.12.1.101 Stability of static airway pressure accuracy (long‐term accuracy) . 19
201.12.1.102 Stability of dynamic airway pressure accuracy (short‐term accuracy) . 20
201.12.1.102.1 CPAP mode . 20
201.12.1.102.2 Bi-level positive airway pressure mode, pressure stability . 22
201.12.1.103 * Maximum flowrate . 24
201.12.4 Protection against hazardous output . 25
201.12.4.101 Measurement of airway pressure . 25
201.12.4.102 * Maximum limited pressure protection device . 25
201.12.4.103 * CO rebreathing . 26
201.13 Hazardous situations and fault conditions . 26
201.14 Programmable electrical medical systems (PEMS) . 26
201.15 Construction of ME equipment . 26
201.15.101 Mode of operation . 26
201.16 ME systems . 27
201.17 Electromagnetic compatibility of ME equipment and ME systems . 27
201.101 Breathing gas pathway connectors . 27
201.101.1 General . 27
201.101.2 Other named ports . 27
201.101.2.1 Patient-connection port . 27
201.101.2.2 Gas output port . 27
201.101.2.3 Flow-direction-sensitive components . 28
201.101.2.4 Ancillary port . 28
201.101.2.5 Monitoring probe port . 28
201.101.2.6 Oxygen inlet port . 28
201.102 Requirements for the breathing gas pathway and accessories . 28
201.102.1 * General . 28
201.102.2 Labelling . 29
201.102.3 Humidification . 29
201.102.4 Breathing system filter (BSF) . 29
201.103 Functional connection . 29
201.103.1 General . 29
201.103.2 * Functional connection to support remote supervision . 30
201.104 Training . 30
202 Electromagnetic disturbances — Requirements and tests . 30
202.4.3.1 Configurations . 30
202.5.2.2.1 Requirements applicable to all ME equipment and ME systems . 30
202.8.1.101 Additional general requirements . 30
206 Usability . 31
211 Requirements for medical electrical equipment and medical electrical systems used
in the home healthcare environment . 31
iv © ISO 2020 – All rights reserved
211.4.2.3.1 Continuous operating conditions . 31
Annex C (informative) Guide to marking and labelling requirements for ME equipment and
ME systems . 33
Annex D (informative) Symbols on marking . 38
Annex AA (informative) Particular guidance and rationale . 39
Annex BB (informative) Data interface requirements . 48
Annex CC (informative) Reference to the IMDRF essential principles and labelling guidances . 52
Annex DD (informative) R
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