CSA C22.2 NO. 60601-2-37:08 (R2019):2008 Edition

CSA Preface

This is the second edition of CAN/CSA-C22.2 No. 60601-2-37, Medical electrical equipment – Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, which is an adoption without modification of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-37 (second edition, 2007-08). It supersedes the previous edition published in 2003 as CAN/CSA-C22.2 No. 60601-2-37, Medical electrical equipment – Part 2-37: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment (adopted IEC 60601-2-37:2001). It is one in a series of Standards issued by CSA under Part II of the Canadian Electrical Code.

This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:08, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (adopted CEI/IEC 60601-1:2005, with Canadian deviations).

This Standard was reviewed for Canadian adoption 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. Due to the medical content of this Standard, it was also approved by the CSA Technical Committee on Applications of Electricity in Health Care under the jurisdiction of the Strategic Steering Committee on Health Care Technology. This Standard has been approved as a National Standard of Canada by the Standards Council of Canada.

Scope

Addition:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of ULTRASONIC DIAGNOSTIC EQUIPMENT as defined in 201.3.217, hereinafter 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 this standard.

NOTE See also subclause 4.2 of this standard.

This particular standard does not cover ultrasonic therapeutic equipment. Equipment used for the imaging or diagnosis of body structures by ultrasound in conjunction with other medical procedures is covered.