Medical electrical equipment – Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment

Designation Number:
CSA C22.2 NO. 60601-2-34
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
New Edition
ICS code(s):
11.040.55
Status:
Open for SDO comment
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

Replacement: 

This part of IEC 60601 applies to BASIC SAFETY and ESSENTIAL PERFORMANCE of INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT as defined in 201.3.63, hereinafter also referred to as ME EQUIPMENT. 

 

This document applies to INVASIVE BLOOD PRESSURE MONITORING EQUIPMENT intended for use in professional healthcare facilities and in the EMERGENCY MEDICAL SERVICE ENVIRONMENT. 

 

This document does not apply to catheter tubing, catheter needles, Luer locks, taps and tap tables that connect to the DOME. 

 

This document does not apply to non-invasive blood pressure monitoring 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 follows:

 

The clause or subclause applies to ME EQUIPMENT, as default and, only if the corresponding safety measure or function is not completely integrated into the ME EQUIPMENT but implemented as part of an ME SYSTEM, the clause or subclause applies to the ME SYSTEM.

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.