CAN/CSA-Z314.15-03 (R2008)

1 Scope 1.1 This Standard provides requirements and recommended practices for the warehousing, storage, handling, and transportation of clean and sterile medical devices in facilities where open-inventory (?split-case?) storage and handling services are provided. Note: The storage facilities covered by this Standard include, but are not limited to, a) warehouses; b) storerooms; and c) storage areas maintained by device reprocessors or laundries working under contract with the health care facility. 1.2 This Standard specifically addresses a) physical and functional requirements for warehouses, storerooms, and other storage facilities that provide open-inventory (?split-case?) storage of clean and sterile medical devices; b) environmental conditions for storage and transportation; c) staff qualifications, orientation, education, and other personnel considerations; d) storage and handling of clean and sterile medical devices; e) transportation to the health care facility and distribution to the sterile storage area or point of use within the facility; f) emergency procedures; and g) quality assurance. 1.3 The following are not addressed in this Standard: a) physical and functional requirements for sterile storage areas (see CAN/CSA-Z314.2 and CAN/CSA-Z314.3); b) reprocessing of reusable medical devices that have become contaminated through accidents or mishandling during storage, transportation, or on-site distribution (see CAN/CSA-Z314.8); c) storage of medical devices at the point of manufacture and transportation between the manufacturer and the warehouse or storage area; and d) storage and transportation of medical devices in their original, factory-sealed shipping containers. 1.4 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. Legends to equations and figures are considered requirements. 1.5 The values given in SI (metric) units are the standard. The values given in parentheses are for information only.