CSA C22.2 NO. 80601-2-13:23 PDF

CSA C22.2 NO. 80601-2-13:23 PDF

CSA Preface

This is the second edition of CSA C22.2 No. 80601-2-13, Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation , which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 80601-2-13 (second edition, 2022-04). It supersedes the previous edition, published in 2015 as CSA C22.2 No. 80601-2-13 (adopted ISO 80601-2-13:2011). 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. 80601-2-13” 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 and related standards

Clause 1 of IEC 60601-1:2005+AMD1:2012+AMD2:2020 applies, except as follows:

NOTE The general standard is IEC 60601-1:2005+AMD1:2012+AMD2:2020. 201.1.1 *

Scope Replacement: This document is applicable to the basic safety and essential performance of an anaesthetic workstation for administering inhalational anaesthesia whilst continuously attended by a professional operator. This document specifies particular requirements for a complete anaesthetic workstation and the following anaesthetic workstation components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant anaesthetic workstation components, to form an anaesthetic workstation to a given specification: – anaesthetic gas delivery system; – anaesthetic breathing system; – anaesthetic gas scavenging system (AGSS); – anaesthetic vapour delivery system; – anaesthetic ventilator; – monitoring equipment; – alarm system; – protection device.

NOTE 1 Monitoring equipment, alarm systems and protection devices are summarized in Table AA.1.

An anaesthetic workstation supplied complete and its individual components are considered as ME equipment or ME systems with regard to the general standard.

NOTE 2 The applicability of this document is indicated in Table AA.2.

This document is also applicable to those accessories intended by their manufacturer to be connected to an anaesthetic workstation where the characteristics of those accessories can affect the basic safety and essential performance of the anaesthetic workstation. If a clause or subclause is specifically intended to be applicable to anaesthetic workstation components or its accessories 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 an anaesthetic workstation and its individual components including accessories, as relevant. Hazards inherent in the intended physiological function of an anaesthetic workstation and its individual components including accessories 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 3 See also IEC 60601-1:2005+AMD1:2012+AMD2:2020, 4.2.

This document is not applicable to any anaesthetic workstation intended for use with flammable anaesthetic agents, as determined by Annex BB.

201.1.2 Object Replacement: The object of this document is to establish particular basic safety and essential performance requirements for an anaesthetic workstation and its individual components designed for use in the anaesthetic workstation (as defined in 201.3.210) and its accessories.

201.1.3 Collateral standards Addition: This document refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this document. IEC 60601-1-3:2008+AMD1:2013+AMD2:2021, IEC 60601-1-9:2007+AMD1:2013+AMD2:2020, IEC 60601-1-11:2015+A1:2020 do not apply.

201.1.4 *Particular standards Addition: The numbering of clauses and subclauses of this document corresponds to that of IEC 60601-1 (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, 206.4 in this document addresses the content of Clause 4 of the IEC 60601-1-6 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 to 3.154, 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 or figures 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, 206 for IEC 60601-1-6, etc. The term “this document” is used to make reference to the general standard, any applicable collateral standards and this particular standard 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. If an anaesthetic workstation is supplied with physiological monitoring, having more than one applied part on the patient, then IEC 80601-2-49:2018 applies. Measured parameters related to the inherent function of an anaesthetic workstation (i.e. airway pressure, ventilation volume, oxygen concentration, volatile anaesthetic agent concentration, CO2/N2O), including derived and related parameters such as spontaneous ventilation volume or CO2 production, are not considered to be a physiological monitoring unit as per IEC 80601-2-49.