CAN/CSA Z314.22-04 PDF

This Standard applies to all organizations that provide, use, transport, or maintain loaned, shared, or leased medical devices.

Note: Medical devices and device sets that are commonly loaned, shared, or leased include those used for orthopaedic surgery, minimally invasive surgery, neurosurgery, and flexible endoscopy, as well as those used for surgical procedures in ophthalmology, gynecology, and urology.

1.2 This Standard specifies requirements for (a) policies and procedures related to the lending, sharing, and leasing of medical devices; (b) accountabilities and responsibilities; (c) staff qualifications, orientation, education, training, and other personnel considerations; (d) transportation between organizations; (e) quality assurance; and (f) emergency procedures.

Note: Examples of the types of transactions covered by this Standard include (a) health care facility to health care facility; (b) department to department, or site to site; (c) vendor to health care facility and health care facility to vendor; and (d) manufacturer to distributor or other affiliate.

1.3 The following areas are not addressed in this Standard: (a) decontamination of reusable medical devices (see CAN/CSA-Z314.8); (b) maintenance; (c) sterilization of medical devices (see CAN/CSA-Z314.2 and CAN/CSA-Z314.3); and (d) single-use medical devices other than those accompanying a loaned, shared, or leased device.

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.