Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

Designation Number:
CSA C22.2 NO. 60601-2-35:22
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
Amendment Revision
ICS code(s):
11.040.01
11.140
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

Scope

Scope and object: CSA C22.2 NO. 60601-2-35:22

 

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

 

201.1.1 * Scope

 

Replacement:

 

This part of 60601 International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of HEATING DEVICES using BLANKETS, PADS or MATTRESSES in medical use, also referred to as ME EQUIPMENT. HEATING DEVICES intended to prewarm a bed are included in the scope of this document.

 

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.

 

If a clause or subclause is specifically intended to be applicable to a specifically defined type of ME EQUIPMENT, as is the case with FORCED AIR DEVICES, then 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 document are not covered by specific requirements in this document, except in 7.2.13 and 8.4.1 of the general standard.

 

NOTE See also 4.2 of the general standard.

 

This document does not apply to:

 

– HEATING DEVICES intended for physiotherapy;

– INFANT RADIANT WARMERS; for information, see IEC 60601-2-21 [1]2;

– INFANT INCUBATORS; for information, see IEC 60601-2-19 [2];

– INFANT TRANSPORT INCUBATORS, for information, see IEC 60601-2-20 [3];

– cooling devices.

 

201.1.2 Object

 

Replacement:

 

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements, which minimize HAZARDS to PATIENTS, and OPERATORS for HEATING DEVICES using BLANKETS, PADS or MATTRESSES and intended for heating in medical use and to specify tests for demonstrating compliance with these requirements.

Project need:

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.