Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment

Designation Number:
CSA C22.2 NO. 60601-2-39
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
New Edition
ICS code(s):
11.040.99
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

201.1 Scope, object and related standards 
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 PERITONEAL DIALYSIS ME EQUIPMENT as defined in 201.3.208, hereafter referred to as PD EQUIPMENT. It applies to PD EQUIPMENT intended for use either by medical staff or under the supervision of medical experts, including PD EQUIPMENT operated by the PATIENT, regardless of whether the PD EQUIPMENT is used in a hospital or domestic environment. 

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 document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard. 

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 Edition and New Standards are being developed at the request of Z290 and C234 Technical Committees. It will provide the industry with the latest requirements for the safety testing of medical devices covered by the standards in Annex A.

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.