Preface:

This is the third edition of CSA C22.2 No. 60601-2-31, Medical electrical equipment — Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-31 (third edition, 2020-01). It supersedes the previous edition, published in 2009 as CAN/CSA-C22.2 No. 60601-2-31 (adopted IEC 60601-2-31:2008). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code.

This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (adopted IEC Standard 60601-1:2005, including Amendment 1:2012, with Canadian deviations).

This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.

Scope:

This part of IEC 60601 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT.

This document applies to PATIENT CABLES as defined in 201.3.209, but does not apply to LEADS as defined in 201.3.206.

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

NOTE See also 4.2 of the general standard.

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

This document does not apply to transthoracic and oesophageal pacing ME EQUIPMENT and 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 201.3.205.