CSA C22.2 NO. 80601-2-70:23

Description

CSA Preface This is the second edition of CSA C22.2 No. 80601-2-70, Medical electrical equipment — Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 80601-2-70 (second edition, 2020-11). It supersedes the previous edition, published in 2017 as CSA C22.2 No. 80601-2-70 (adopted ISO 80601-2-70:2015). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code. For brevity, this Standard will be referred to as “CSA C22.2 No. 80601-2-70” throughout. This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (adopted IEC Standard 60601-1:2005, edition 3.2, with Canadian deviations). This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard. This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Consumer and Commercial Products, under the jurisdiction of the CSA Strategic Steering Committee on Requirements for Electrical Safety, and has been formally approved by the Technical Committee. Due to the medical content of this Standard, it was also approved by the CSA Technical Committee on Application of Electricity in Health Care, under the jurisdiction of the CSA Strategic Steering Committee on Health and Well-being. This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group. Scope and object 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. 201.1.1 Scope IEC 60601-1:2005+Amendment 1:2012, 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 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]. 201.1.2 Object IEC 60601-1:2005, 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 201.3.215). NOTE 1 This document has been prepared to address the relevant essential principles[17] and labelling[18] 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 essential principles of safety and performance of ISO 16142-1:2016 as indicated in Annex DD. NOTE 3 This document has been prepared to address the relevant general safety and performance requirements of European regulation (EU) 2017/745[16] as indicated in Annex EE.