This is the fifth edition of CSA Z314.1, Ethylene oxide sterilizers for health care facilities. It supersedes the previous editions, published in 2001, 1991, 1984, and 1977. It is one in a series of CSA Standards dealing with the safe and effective sterilization of medical supplies and equipment.
This Standard applies to ethylene oxide sterilizers that have automatic controls and are intended for general-purpose use in health care facilities.
(1) The term health care facilities includes, but is not limited to, hospitals, nursing homes, extended-care facilities, clinics, medical and dental offices, and health units in industry.
(2) This Standard is intended for manufacturers of ethylene oxide sterilizers. Tests involving modifications to the sterilizer controls or safety features can present hazards to those who do not possess specialized testing equipment and the expertise to conduct the tests.
This Standard specifies minimum construction, performance, testing, and labelling requirements to ensure that
(a) the environment in the sterilizing chamber is effective in sterilizing products; and
(b) personnel using the equipment are protected from hazards associated with ethylene oxide.
This Standard does not provide requirements for the following:
(a) pre- or post-sterilization procedures;
(b) machine operators;
(c) venting of waste gases used in the sterilization process; and
(d) tests to indicate the probability of product sterility.
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.