Medical electrical equipment – Part 2-58: Particular requirements for the basic safety and essential performance of lens removal devices and vitrectomy devices for ophthalmic surgery

Designation Number:
CSA C22.2 NO. 80601-2-58
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
New Edition
ICS code(s):
11.040.70
Status:
Open for SDO comment
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

Replacement:

 

This part of IEC 80601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of LENS REMOVAL DEVICES and VITRECTOMY DEVICES for ophthalmic surgery (as defined in 201.3.209 and 201.3.217) and associated ACCESSORIES that can be connected to this MEDICAL ELECTRICAL EQUIPMENT, hereafter 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 document are not covered by specific requirements in this document except in 7.2.13 of IEC 60601-1:2005 and IEC 60601-1:2005/AMD2:2020 and 8.4.1 of IEC 60601-1:2005. 

 

NOTE See also 4.2 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.

Project need:

To maintain alignment with international requirements. This proposed New Edition is 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. 

 

This will meet the strategic needs of the following key interests:

  1. ensuring that the latest innovative/technology/safety features are available for users,
  2. addressing needs of regulators by providing suitable requirements; and   
  3. supporting certification bodies.

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.