CSA C22.2 NO. 60601-2-11:15 (R2019):2015 Edition

CSA Preface

This is the third edition of CAN/CSA-C22.2 No. 60601-2-11, Medical electrical equipment – Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-11 (third edition, 2013-01). It supersedes the previous edition published in 2001 as CAN/CSA-C22.2 No.60601-2-11 (adopted IEC 60601-2-11:1997). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code.

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 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

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 GAMMA BEAM THERAPY EQUIPMENT, including MULTI-SOURCE STEREOTACTIC RADIOTHERAPY equipment, hereafter referred to as ME EQUIPMENT.

If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS 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 ME EQUIPMENT and to ME SYSTEMS, as relevant.

HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

NOTE See also 4.2 of the general standard.

201.1.2 Object

Replacement:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for GAMMA BEAM THERAPY EQUIPMENT.

Published Code	CSA
Published By	Canadian Standards Association
Publication Date	2015-01-01
Pages Count	126
Language	France
Edition	3
File Size	2.1 MB
ISBN	9781771397438
ICS Codes	11.040.60 - Therapy equipment