Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment

Designation Number:
CSA C22.2 NO. 60601-2-37:08 (R2023)
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
Amendment Revision
ICS code(s):
11.040.55
17.150.50
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

Scope: CSA C22.2 NO. 60601-2-37:08 (R2023)

 

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.

 

Project need:

To maintain alignment with international requirements (new edition of adoption, new adopted standard, new  amendment of an adopted standard, etc.)  This proposed New Amendment are being developed at the request of CSA Technical Committees. It will provide the industry with the latest requirements for the safety testing of medical devices

Note: The information provided above was obtained by the Standards Council of Canada (SCC) and is provided as part of a centralized, transparent notification system for new standards development. The system allows SCC-accredited Standards Development Organizations (SDOs), and members of the public, to be informed of new work in Canadian standards development, and allows SCC-accredited SDOs to identify and resolve potential duplication of standards and effort.

Individual SDOs are responsible for the content and accuracy of the information presented here. The text is presented in the language in which it was provided to SCC.