CSA Z314.15-15

1.1 This Standard specifies requirements and recommended practices for the storage, handling, transportation, and distribution of single use and reusable 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 storerooms, and other storage facilities that provide open-inventory (split-case) storage of single use and reusable single use or reusable medical devices; Note: See CSA Z314.0 for additional requirements for sterile storage areas for reprocessed products. b) environmental conditions for storage and transportation; c) staff qualifications, orientation, and education; occupational health and safety; and other personnel considerations; d) storage and handling of single use and reusable medical devices; e) management of case cart systems; f) onsite distribution; and g) emergency procedures. 1.3 The storage facilities covered by this Standard include the following: a) sterile storage areas associated with operating room and medical device reprocessing areas including third party/off site reprocessors (tier 1) (i.e., single use opened case products and reprocessed medical devices); b) storage areas outside of the sterile core within the health care setting that store both clean and sterile inventory (tier 2) (i.e., single use opened case products and reprocessed medical device); and c) storage areas that distribute and/or transport open single use inventory clearly separated from storage areas that distribute and/or transport closed cases (tier 3). Note: Tier 3 can include onsite and offsite warehouse storage locations. 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) warehousing that does not include low unit of measure (opened case product) distribution (e.g., vendor warehouse with bulk storage). 1.5 In this Standard, “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 (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.