Scope

1.1
This Standard specifies essential elements in implementing a program for using chemicals to sterilize medical devices in health care facilities. Such chemicals can be vapour, gaseous, or liquid and are delivered in validated concentrations and quantities in defined sterilizers.
The body of this Standard contains requirements that are common to all chemical sterilization processes, whereas requirements specific to a particular chemical sterilization technology are contained in Annexes A to E.
The following chemical sterilants are currently approved for use in sterilizers in Canada and are addressed in this Standard:
(a) gaseous and vapour chemicals:
(i) ethylene oxide;
(ii) hydrogen peroxide;
(iii) ozone; and
(iv) hydrogen peroxide-ozone; and
(b) liquid chemicals: peracetic acid.
Exposure to chemical sterilants can present risks to health care personnel and patients; this Standard includes measures to minimize the risk of such exposure as well as discharge to the environment of sterilizing chemicals and by-products.

1.2
This Standard includes general requirements for
(a) policies, procedures, and documentation;
(b) personnel qualifications and training;
(c) quality system;
(d) evaluation and purchase of reusable medical devices;
(e) work areas and equipment;
(f) preparation and packaging of medical devices requiring sterilization;
(g) sterilizer loading, unloading, and operation;
(h) procedures required following sterilization, to minimize sterilant residuals;
(i) storage of sterilized medical devices;
(j) sterility assurance, including process challenge device (PCD) construction and use;
(k) sterilizer maintenance and quality assurance; and
(l) occupational health and safety issues specifically related to chemical sterilization.
Note: "Process challenge device" (PCD) has replaced the term "test pack".

1.3
This Standard contains particular requirements for chemical sterilization and is to be used in conjunction with CSA Z314.3 and CAN/CSA-Z314.8. Where differences exist, the requirements of this Standard apply.

1.4
This Standard does not address
(a) a high-level disinfectant (e.g., glutaraldehyde) when it is used as a high-level disinfectant or sterilant;
(b) inactivation of chemically resistant parasites and protozoa;
(c) decontamination of reusable medical devices prior to sterilization; Note: See CAN/CSA-Z314.8.
(d) steam sterilization of reusable medical devices;
Note: See CSA Z314.3.
(e) manufacturers' requirements for construction and performance of ethylene oxide sterilizers;
Note: See CSA Z314.1.
(f) installation and ventilation of ethylene oxide sterilizers;
Note: See CAN/CSA-Z314.9.
g) single-use/disposable medical devices; or
(h) medical devices that have been used with patients who are known or suspected to have Creutzfeldt-Jakob Disease or prion-related diseases.
Note: Refer to the Health Canada publication Infection Control Guidelines: Classic Creutzfeldt-Jakob Disease in Canada: Quick Reference Guide.

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; 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.