Scope
1.1
This Standard applies to the use of medical devices and systems for the application of electrosurgical energy. It applies to all procedures in all health care settings where such medical devices and systems are used, including, but not limited to, the following:
a) surgical facilities;
b) dental clinics;
c) medical offices;
d) veterinary facilities;
e) laboratories and other research facilities;
f) cosmetic treatment facilities;
g) teaching facilities; and
h) professional exhibitions and trade shows. 1.2
This Standard provides requirements for the education, training, purchasing, installation, use, service, and maintenance of electrosurgical units (ESUs). 1.3
This Standard does not include requirements for
a) aspects of laser safety (see CSA Z386);
b) aspects of other energy-based medical device safety not utilizing electricity to deliver a therapeutic effect (e.g., ultrasonic scalpels); and
c) surgical plume. 1.4
In this Standard, "shall" is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard; "should" is used to express a recommendation or that which is advised but not required; and "may" is used to express an option or that which is permissible within the limits of the standard. Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material. Notes to tables and figures are considered part of the table or figure and may be written as requirements. Annexes are designated normative (mandatory) or informative (nonmandatory) to define their application.