CAN/CSA-Z314.2-01 (R2007)

1. Scope Caution: ETHYLENE OXIDE IN LIQUID AND VAPOUR FORM IS ACUTELY TOXIC AND HAS BEEN CLASSIFIED AS A HUMAN CARCINOGEN BY THE INTERNATIONAL AGENCY FOR RESEARCH ON CANCER. FOR PROVISION OF ADEQUATE PROTECTION AGAINST THESE EFFECTS, REFER TO FEDERAL AND PROVINCIAL REGULATIONS AND TO CSA STANDARD Z314.9. 1.1 This Standard outlines essential elements in a program for using ethylene oxide to sterilize products in health care facilities in order to achieve an adequate level of sterility assurance and to minimize the risk of injury to patients and to the health and safety of staff. This standard applies to all sterilization processes that use an ethylene oxide sterilizer in accordance with CSa Standards Z314.1 and Z314.9. Notes: 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) Figure 1 shows the scope of this Standard within the reprocessing of reusable medical devices. (3) Comprehensive guidance for small, office-based facilities can be found in CSA Publication PLUS 1112. 1.2 This Standard includes requirements for (a) work areas; (b) personnel qualifications and training; (c) preparation and packaging of medical devices requiring sterilization; (d) sterilizer loading and operation; (e) aeration following sterilization; (f) storage of sterilized medical devices; (g) sterility assurance, including test pack construction and use; (h) product evaluation for sterilizable products and packaging materials; and (i) maintenance and sterilizer quality assurance. 1.3 This Standard does not apply to (a) construction and performance of ethylene oxide sterilizers; Note: See CSA Standard Z314.1. (b) installation and ventilation of ethylene oxide sterilizers; and Note: See CSA Standard Z314.9, (c) decontamination of reusable medical devices prior to sterilization. Note: See CSA Standard Z314.8. 1.4 In this Standard, "shall" indicates a mandatory requirement; "should" indicates a recommendation or that which is advised but not mandatory; and "may" indicates an advisory or optional statement. Notes accompanying clauses do not include mandatory or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material that is not properly a part of the Standard. Notes to figures and tables are considered part of the figure or table and may be written as mandatory requirements; legends to figures are also considered part of the requirements of the figure.