CAN/CSA-Z314.3-01 (R2007)

1. Scope 1.1 This Standard outlines essential elements in a program for using steam to sterilize medical devices in health care facilities, with the object of achieving an adequate level of sterility assurance and minimizing the risk of injury to the operators of steam sterilization equipment. 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 Special 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) storage of sterilized medical devices; (f) sterility assurance, including test pack construction and use; (g) product evaluation for sterilizable medical devices and packaging materials; and (h) maintenance and sterilizer quality assurance. 1.3 This Standard does not apply to (a) emergency (flash) sterilization; Note: See CSA Standard Z314.13. (b) construction and performance of steam sterilizers; Note: See CSA Standard CAN/CSA-Z314.7. (c) washer/sterilizers; or (d) 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.