CSA C22.2 NO. 60601-2-28:18:2018 Edition

CSA Preface

This is the third edition of CSA C22.2 No. 60601-2-28, Medical electrical equipment — Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-28 (third edition, 2017-06). It supersedes the previous edition, published in 2012 as CAN/CSA-C22.2 No. 60601-2-28, (adopted IEC 60601-2-28:2010). 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. 60601-2-28 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.

201.1 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 X-RAY TUBE ASSEMBLIES and to components thereof, intended for medical diagnosis and imaging.

Where the general standard IEC 60601-1 and the collateral standard IEC 60601-1-3 refer to ME EQUIPMENT, this is interpreted as X-RAY TUBE ASSEMBLIES in this particular standard. 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.

NOTE This document is also applicable to the X-RAY TUBE ASSEMBLY aspects of X-RAY SOURCE ASSEMBLIES and XRAY TUBE HEADS.

201.1.2 Object

Replacement:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for X-RAY TUBE ASSEMBLIES for medical diagnosis.

Published Code	CSA
Published By	Canadian Standards Association
Publication Date	2018-12-01
Pages Count	77
Language	France
Edition	3
File Size	3.4 MB
ISBN	9781488320422
ICS Codes	11.040.55 - Diagnostic equipment