This is the third edition of CSA Z314.9, Installation, ventilation, and safe use of ethylene oxide sterilizers in health care facilities. It supersedes the previous editions, published in 2001 and 1989. It is one of a series of standards dealing with the safe and effective sterilization of medical supplies and equipment.
Scope
1.1
This Standard provides information to assist health care facilities in devising work practices that will maximize employee safety when using ethylene oxide sterilizers and ancillary equipment.
1.2
This Standard specifies requirements for the following:
(a) the installation of ethylene oxide sterilization equipment;
(b) general area and local exhaust ventilation;
(c) staff training;
(d) monitoring alarm systems; and
(e) contingency planning.
1.3
This Standard does not address sterilizer efficacy, which is dealt with in CSA Z314.2.
1.4
This Standard does not cover safety issues that are specific to individual equipment models or to individual health care facilities.
1.5
In CSA Standards, “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; “may” is used to express an option or that which is permissible within the limits of the standard; and “can” is used to express possibility or capability. 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.