CSA Z314.23-16

1.1 This Standard specifies essential elements for using chemical processes to sterilize medical devices in health care settings, with the object of achieving an adequate level of sterility assurance and minimizing the risk of injury to health care setting personnel and patients. Note: The term “health care setting” includes, but is not limited to, hospitals, free standing surgical centres, nursing homes, extended-care facilities, clinics, medical and dental offices, and health units in industry. See CSA Z314.0 for a more comprehensive definition. The following chemical sterilants are currently approved for use in sterilizers in Canada and are addressed in this Standard: a) gaseous and vapourized chemicals: i) ethylene oxide; ii) hydrogen peroxide; iii) hydrogen peroxide-ozone; and b) liquid chemicals: i) 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 any harmful sterilizing chemicals and by-products. 1.2 This Standard includes chemical sterilization specific requirements for a) work areas and equipment; b) preparation and packaging of medical devices; c) sterilizer loading, unloading, and operation; d) procedures that might be required following sterilization, to minimize sterilant residuals; e) sterility assurance, including process challenge device (PCD) and use; f) sterilizer maintenance and quality assurance; and g) occupational health and safety (OHS) issues specifically related to chemical sterilization systems. 1.3 This Standard contains particular requirements for chemical sterilization and is to be used in conjunction with CSA Z314.0, CSA Z314.3, CSA Z314.8, CSA Z314.14, CSA Z314.15, CSA Z314.10.1, CSA Z314.10.2, and CAN/CSA-Z314.22. 1.4 This Standard does not address a) general requirements applicable to all sterilization methods; Note: See CSA Z314.0. b) decontamination of reusable medical devices; Note: See CSA-Z314.8. c) the manual use of liquid chemical sterilants; Note: See CSA Z314.8. d) automated use of high level disinfectants; Note: See CSA Z314.8. e) steam sterilization of reusable medical devices; Note: See CSA Z314.3. f) sterile barrier systems; Note: See CSA Z314.14. g) storage, distribution, and transportation of sterilized medical devices; Note: See CSA Z314.15. h) manufacturers’ requirements of ethylene oxide sterilizers; Note: See CAN/CSA Z11135. i) installation and ventilation of ethylene oxide sterilizers; Note: See CAN/CSA-Z314.9. j) inactivation of chemically resistant parasites and protozoa; k) single-use/disposable medical devices; and l) medical devices that have been used with patients who are known or suspected to have prionrelated diseases (e.g., Creutzfeldt-Jakob Disease). Note: Refer to the Health Canada publication Infection Control Guidelines: Classic Creutzfeldt-Jakob Disease in Canada: Quick Reference Guide. 1.5 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.