CSA Preface
This is the third edition of 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, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-13 (third edition, 2003-05), including Amendment 1:2006. It supersedes the previous edition published in 2002 as CAN/CSA-C22.2 No. 60601-2-13, Medical electrical equipment - Part 2-13: Particular requirements for the safety of anaesthetic workstations (adopted IEC 60601-2-13:1998). At the time of publication, IEC 60601-2-13:2003 and Amendment 1:2006 are available from IEC in English only. CSA will publish the French versions when they become available from IEC.
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 Subcommittee on Anaesthetic Equipment, under the jurisdiction of the CSA Technical Committee on Anaesthetic Equipment, Respiratory Technology, and Critical Care Equipment and the Strategic Steering Committee on Health Care Technology, and has been formally approved by the Technical Committee. This Standard was also reviewed by the CSA Technical Committee on Consumer and Commercial Products, under the jurisdiction of the Strategic Steering Committee on Requirements for Electrical Safety, and has been formally approved by the Technical Committee. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada.
Scope and object
This clause of the General Standard applies except as follows:
1.1 Scope
Addition
This Particular Standard specifies safety and essential performance requirements for an ANAESTHETIC SYSTEM (as defined in 2.101.7) as well as individual devices designed for use in an ANAESTHETIC SYSTEM.
This Particular Standard does not apply to:
- ANAESTHETIC SYSTEM(S) intended for use with flammable anaesthetic agents, as determined by Annex DD,
- portable ANAESTHETIC SYSTEM(S) for use in remote sites, open fields for rescue operations or in disaster areas,
- dental analgesia apparatus.
