Warehousing, storage, and transportation of clean and sterile medical devices

1.1 This Standard specifies 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.

1.2 This Standard covers (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; Note: See CSA Z314.2 and CSA Z314.3 for additional requirements for sterile storage areas. (b) environmental conditions for storage and transportation; (c) staff qualifications, orientation, and education; occupational health and safety; and other personnel considerations; (d) quality systems requirements; (e) storage and handling of clean and sterile medical devices; (f) special handling for case carts; (g) transportation to the health care facility and distribution to the sterile storage area or point of use within the facility; and (h) emergency procedures.

1.3 The storage facilities covered by this Standard include (a) warehouses; (b) storerooms; and (c) storage areas maintained by device reprocessors or laundry services working under contract with the health care facility.

1.4 This Standard does not apply to (a) the reprocessing of reusable medical devices that have become contaminated through accident or mishandling during storage, transportation, or on-site distribution; Note: See CSA Z314.8. (b) the storage of medical devices at the point of manufacturing; (c) transportation between the point of manufacturing and the warehouse or storage area; and (d) sterile storage areas associated with operating room and medical device reprocessing areas. Note: See CSA Z314.2 and CSA Z314.3.

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; "may" is used to express an option or that which is permissible within the limits of the standard; and "can" is used to express possibility or capability. 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.

1.6 The values given in SI units are the units of record for the purposes of this Standard. The values given in parentheses are for information and comparison only.