CSA C22.2 No. 60601-2-31:20
This Standard applies to ME EQUIPMENT and ME SYSTEMS that are intended to be installed or used in
accordance with CSA C22.1, Canadian Electrical Code, Part I.
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.
SDO:
CSA
Language:
English
ICS Codes:
11.040.01
Status:
Standard
Publish date:
2020-05-31
Standard Number:
CSA C22.2 No. 60601-2-31:20