CAN/CSA-C22.2 No. 60601-2-2-09 (R2014)

Preface This is the fourth edition of CAN/CSA-C22.2 No. 60601-2-2, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-2 (fifth edition, 2009-02). It supersedes the previous edition, published in 2008 as CAN/CSA-C22.2 No. 60601-2-2, Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment (adopted CEI/IEC 60601-2-2:2006). It is one in a series of Standards issued by CSA under Part II of the Canadian Electrical Code. Scope, object and related standards Clause 1 of the general standard1) applies, except as follows: 201.1.1 Scope Replacement: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HF SURGICAL EQUIPMENT as defined in 201.3.222. HF SURGICAL EQUIPMENT having a RATED OUTPUT POWER not exceeding 50 W (for example for micro-COAGULATION, or for use in dentistry or ophthalmology) is exempt from certain of the requirements of this particular standard. These exemptions are indicated in the relevant requirements 201.1.2 Object Replacement: The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for HF SURGICAL EQUIPMENT as defined in 201.3.222. 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 2 of this particular standard. IEC 60601-1-2 and IEC 60601-1-8 apply as modified in Clauses 202 and 208 respectively. IEC 60601-1-3, IEC 60601-1-10 and IEC 60601-1-112) do not apply. All other published collateral standards in the IEC 60601-1 series apply as published.