CSA C22.2 NO. 80601-2-84:24

CSA C22.2 NO. 80601-2-84:24 PDF

CSA Preface

This is the second edition of CSA C22.2 No. 80601-2-84, Medical electrical equipment — Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment , which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 80601-2-84 (second edition, 2023-11). It supersedes the previous edition, published in 2021 as CSA C22.2 No. 80601-2-84 (adopted ISO 80601-2-84:2020). 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. 80601-2-84” 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. 201.1 Scope and object IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 1 applies, except as follows: 201.1.1 Scope Replacement:

NOTE 1 There is guidance or rationale for this subclause contained in Clause AA.2. This document applies to the basic safety and essential performance of an EMS ventilator in combination with its accessories, hereafter also referred to as ME equipment: – intended for patients who need differing levels of support from artificial ventilation including ventilator-dependent patients; – intended to be operated by a healthcare professional operator; – intended for use in the EMS environment; and – intended for invasive or non-invasive ventilation.

NOTE 2 An EMS ventilator can also be used for transport within a professional healthcare facility. An EMS ventilator is not considered to use a physiologic closed loop-control system unless it uses a physiological patient variable to adjust the artificial ventilation therapy settings. This document is also applicable to those accessories intended by their manufacturer to be connected to the ventilator breathing system, or to an EMS ventilator, where the characteristics of those accessories can affect the basic safety or essential performance of the EMS ventilator.

NOTE 3 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 IEC 60601-1:2005 +AMD1:2012+AMD2:2020, 7.2.13 and 8.4.1.

NOTE 4 Additional information can be found in IEC 60601-1:2005+AMD1:2012 +AMD2:2020, 4.2. This document does not specify the requirements for the following:

NOTE 5 See ISO/TR 21954 for guidance on the selection of the appropriate ventilator for a given patient. – ventilators or accessories intended for ventilator-dependent patients in critical care applications, which are given in ISO 80601-2-12. – ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72. – ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13. – ventilators or accessories intended for ventilatory support equipment (intended only to augment the ventilation of spontaneously breathing patients), which are given in ISO 80601-2-79 and ISO 80601-2-80. – obstructive sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70. – user-powered resuscitators, which are given in ISO 10651-4. – gas-powered emergency resuscitators, which are given in ISO 10651-5. – continuous positive airway pressure (CPAP) ME equipment. – high-frequency jet ventilators (HFJVs), which are given in ISO 80601-2-87. – high-frequency oscillatory ventilators (HFOVs)[44], which are given in ISO 80601-2-87.

NOTE 6 An EMS ventilator can incorporate high-frequency jet or high-frequency oscillatory ventilation-modes. – respiratory high-flow therapy equipment, which are given in ISO 80601-2-90.

NOTE 7 An EMS ventilator can incorporate high-flow therapy operational mode, but such a mode is only for spontaneously breathing patients. – oxygen therapy constant flow ME equipment. – cuirass or “iron-lung” ventilators.

201.1.2 Object Replacement: The object of this particular document is to establish basic safety and essential performance requirements for an EMS ventilator, as defined in 201.3.228, and its accessories. Accessories are included because the combination of the EMS ventilator and the accessories needs to have acceptable risk. Accessories can have a significant impact on the basic safety or essential performance of an EMS ventilator.

NOTE 1 This document has been prepared to address the relevant essential principles[38] and labelling[39] 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 [40].