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CSA C22.2 NO. 60601-2-2:19:2019 Edition

$79.30

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

Published By Publication Date Number of Pages
CSA 2019-03-01 215
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CSA Preface

This is the fifth edition of 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, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-2 (sixth edition, 2017-03). It supersedes the previous edition, published in 2009 as CAN/CSA-C22.2 No. 60601-2-2 (adopted IEC 60601-2-2:2009). 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. 60601- 2-2 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, including Amendment 1:2012, with Canadian deviations).

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 and object

Clause 1 of the general standard1 applies, except as follows:

201.1.1 * Scope

Replacement:

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HF SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES as defined in 201.3.224 and 201.3.223.

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 and HF SURGICAL ACCESSORIES as defined in 201.3.224 and 201.3.223.

CSA C22.2 NO. 60601-2-2:19
$79.30