CSA C22.2 NO. 80601-2-13:15 (R2020)

CSA Preface This is the first edition of CAN/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 (first edition, 2011-08-01). It replaces the previous edition, published in 2007 as CAN/CSA-C22.2 No. 60601-2-13, Medical electrical equipment — Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems (adopted IEC 60601-2-13:2003+A1:2006). 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 “CAN/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 60601-1:2005+A1:2012, 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 Perioperative Safety under the jurisdiction of the CSA Strategic Steering Committee on Health Care Technology & Systems. 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, object and related standards IEC 60601-1:2005, Clause 1 applies, except as follows: 201.1.1 * Scope Replacement: This International Standard 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 International Standard 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; ⎯ 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 International Standard is indicated in Table AA.2. This International Standard 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 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, as relevant. HAZARDS inherent in the intended physiological function of an ANAESTHETIC WORKSTATION and its individual components within the scope of this International Standard are not covered by specific requirements in this International Standard except in 7.2.13 and 8.4.1 of the general standard. NOTE 3 See also 4.2 of the general standard. This International Standard 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 particular standard 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 201.3.211) and its ACCESSORIES. 201.1.3 Collateral standards Addition: This particular standard refers to those applicable collateral standards that are listed in Clause 2 of the general standard and Clause 201.2 of this particular standard. IEC 60601-1-3:2008 and IEC 60601-1-11:2010 do not apply. 201.1.4 Particular standards Replacement: In the IEC 60601 series, particular standards may modify, replace or delete requirements contained in the general standard and collateral standards, as appropriate for the particular ME EQUIPMENT under consideration, and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements. A requirement of a particular standard takes priority over the general standard. For brevity, IEC 60601-1:2005 is referred to in this particular standard as the general standard. Collateral standards are referred to by their document number. The numbering of clauses and subclauses of this particular standard corresponds to that of the general standard with the prefix “201” (e.g. 201.1 in this standard 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 particular standard addresses the content of Clause 4 of the IEC 60601-1-2 collateral standard, 206.4 in this particular standard 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 particular standard. “Addition” means that the text of this particular standard 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 particular standard. 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 3.139, additional definitions in this standard 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 standard” 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 particular standard, 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 particular standard.