Selection and use of rigid sterilization containers

1.1 This Standard defines essential elements for the selection, use, and maintenance of rigid sterilization containers. The selection criteria include minimum construction and performance requirements to help health care facilities choose products that are appropriate for their intended use.

1.2 This Standard applies to the following types of rigid sterilization containers: (a) protective organizing cases or trays that need additional wrapping or an additional method of containment for sterilization and maintenance of sterility; (b) rigid sterilization container systems that do not need additional wrapping; and (c) trays and cassettes intended for use in sterilization processes that do not rely on wrapping, such as emergency (flash) and point-of-use sterilization.

1.3 This Standard sets forth requirements in the following areas: (a) policies and procedures related to the use of rigid sterilization containers; (b) general characteristics, selection, and purchasing of rigid sterilization containers; (c) evaluation of the design, performance, and labelling of containers; (d) personnel education and training and occupational health and safety; (e) matching of containers to appropriate sterilization methods and cycles; (f) testing prior to use; (g) decontamination, preparation, and assembly of rigid sterilization containers; (h) wrapping of containers, where applicable; (i) sterilizer loading and unloading; (j) sterile storage; (k) on-site distribution and off-site transportation of rigid sterilization containers; (l) infection prevention and control; (m) aseptic presentation and use; and (n) quality assurance. In addition, this Standard addresses the preparation, handling, and loading of medical devices in containerized sets.

1.4 This Standard does not provide requirements for (a) ongoing sterility assurance programs in health care facilities; or (b) textile packs. Note: CSA Z314.2 and CSA Z314.3 provide requirements for ethylene oxide and steam sterilization in health care facilities. CSA Z314.10.1 provides requirements for the selection and use of reusable surgical textiles.

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.