Medical electrical equipment — Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source

Designation Number:
CSA C22.2 NO. 60601-2-31
Standard Type:
National Standard of Canada - Adoption of International Standard
Standard Development Activity:
New Edition
Status:
Proceeding to development
SDO Comment Period Start Date:
SDO Comment Period End Date:
Posted On:

Scope:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as 188 ME EQUIPMENT.

 

This standard applies to PATIENT CABLES as defined in 201.3.109, but does not apply to LEADS as defined in 201.3.106.

 

HAZARDS inherent in the intended physiological function of ME EQUIPMENT within the scope of this standard are not covered by specific requirements in this standard except in 7.2.13 and 8.4.1 of the general standard.

 

NOTE See also 4.2 of the general standard.

 

This standard does not apply to the implantable parts of ACTIVE IMPLANTABLE MEDICAL DEVICES covered 191 by ISO 14708-1 This standard does not apply to EXTERNAL PACEMAKERS which can be connected directly or indirectly to a SUPPLY MAINS.

 

This standard does not apply to transthoracic and oesophageal pacing ME EQUIPMENT and 194 antitachycardia ME EQUIPMENT.

 

The object of this particular standard is to establish particular BASIC SAFETY and ESSENTIAL PERFORMANCE requirements for EXTERNAL PACEMAKERS AS DEFINED IN 201.3. 103.

 

Project need:

To maintain alignment with international requirements on the particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source.

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