Safe use of electrosurgical medical devices and systems in health care
|Publication Date:||1 January 2019|
|ICS Code (Surgical instruments and materials):||11.040.30|
This Standard deals with the following subjects:
a) the use of electrical surgical units (ESUs) - medical devices and systems for the application of electrosurgical energy;
b) training for the use of ESUs; and
c) the installation of ESUs in any health care facility (HCF), as defined in Clause 3.
This Standard provides requirements for the education, training, purchasing, installation, use, service, and maintenance of ESUs.
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.
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 (non-mandatory) to define their application.