Medical electrical equipment - Part 2-46: Particular requirements for the basic safety and essential performance of operating tables

Designation Number:
CSA C22.2 NO. 60601-2-46
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
New Edition
ICS code(s):
11.140
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

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

201.1.1 Scope

Replacement:

This particular standard specifies safety requirements for OPERATING TABLES, whether or not having electrical parts, including TRANSPORTERS, used for the transportation of the OPERATING TABLE top to or from the base or pedestal of an OPERATING TABLE with detachable OPERATING TABLE top.

NOTE See also 4.2 of the General Standard.

This particular standard does not apply to

– dental PATIENT chairs;
– examination chairs and couches;
– PATIENT-supporting systems of diagnostic and therapeutic devices; (see IEC 60601-2-43)
– OPERATING TABLE heating blankets; (see IEC 80601-2-35)
– PATIENT transfer equipment;
– delivery tables and beds;
– medical beds; (see IEC 60601-2-52)
– field tables.

If OPERATING TABLES will be used in combination with diagnostic and/or therapeutic devices the relevant requirements of each related particular standard are also applicable.

201.1.2 Object

Replacement:

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for OPERATING TABLES as defined in 201.3.201.

Project need:

To update the current standard due to user experience/feedback/new technology (new edition). Harmonization with UL standards. This proposed New Edition is being developed at the request of Industry, regulators, and Certification agencies. It will provide the industry with updated references and requirements based on current best practices.

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.