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CSA Z387:19:2019 Edition

CSA Z387:19:2019 Edition

$24.05

Safe use of electrosurgical medical devices and systems in health care

Published By Publication Date Number of Pages
CSA 2019-03-01 35
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Preface

This is the second edition of CSA Z387, Safe use of electrosurgical medical devices and systems in health care. It supersedes the previous edition published in 2013.

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

1.1

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.

1.2

This Standard provides requirements for the education, training, purchasing, installation, use, service, and maintenance of 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 (non-mandatory) to define their application.

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