Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

Designation Number:
CSA C22.2 NO. 80601-2-77:19
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
Amendment Revision
ICS code(s):
11.040.01
Status:
Proceeding to development
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 ROBOTICALLY 
ASSISTED SURGICAL EQUIPMENT (RASE) and ROBOTICALLY ASSISTED SURGICAL SYSTEMS 
(RASS), hereafter referred to as ME EQUIPMENT and ME SYSTEMS together with their INTERACTION 
CONDITIONS and INTERFACE CONDITIONS. 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 RASE or RASS, or its ACCESSORIES fall within scope of another particular standard, then the 
particular standard applies in addition to this standard. 

EXAMPLES IEC 60601-2-2[3] for HF SURGICAL EQUIPMENT; IEC 60601-2-18[4] for ENDOSCOPIC 
EQUIPMENT; IEC 60601-2-22[5] for laser equipment; IEC 60601-2-37[6] for ultrasound equipment; IEC 
60601-2-46[7] for operating tables, etc. 

Project need:

To maintain alignment with international requirements. This proposed 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. This will meet the strategic needs of the following key interests: a) ensuring that the latest innovative/technology/safety features are available for users, b) addressing needs of regulators by providing suitable requirements; and c) supporting certification bodies.

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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.