scope:

This Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS designed to be used in accordance with CSA C22.1 (Canadian Electrical Code, Part I) and CSA Z32.

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 relevant.

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

NOTE 1 See also 4.2.

Note 1A: In the IEC 60601 Standards series adopted for use in Canada, the Canadian standards may modify, replace, or delete requirements contained in the IEC standard as appropriate to the ME EQUIPMENT and ME SYSTEMS under evaluation, and they may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements.

The IEC 60601 series does not apply to:

- in vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT, which is covered by the IEC 61010 series [61];

- implantable parts of active implantable medical devices covered by the ISO 14708 series [69]; or

- medical gas pipeline systems covered by ISO 7396-1 [68].

NOTE 2 ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and ALARM SIGNALS.