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1.1 This Standard specifies requirements for the lending, sharing, and leasing of (a) critical and semi-critical medical devices; and (b) other medical devices, such as implants or single-use devices, that accompany the loaned, shared, or leased device.

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.

 

Document History

  1. CAN/CSA Z314:23


    Canadian medical device reprocessing in all health care settings

    • Most Recent
  2. CAN/CSA Z314-18


    Canadian medical device reprocessing

    • Historical Version
  3. CSA Z314.23-16


    Chemical sterilization of reusable medical devices in health care settings

    • Historical Version
  4. CSA Z314.22-16


    Management of loaned, reusable medical devices

    • Historical Version
  5. CSA Z314.10.2-15


    Laundering, maintenance, and preparation of reusable gowns, drapes, and wrappers for health care settings and laundries

    • Historical Version
  6. CSA Z314.10.1-15


    Selection and use of gowns and drapes intended for use in health care facilities

    • Historical Version
  7. CSA Z314.15-15


    Storage, transportation, and distribution of single use and reusable medical devices

    • Historical Version
  8. CSA Z314.14-15


    Selection and use of packaging (sterile barrier systems) in healthcare settings

    • Historical Version
  9. CSA Z314.3-14


    Effective sterilization in health care settings by the steam process

    • Historical Version
  10. CSA Z314.8-14


    Decontamination of Reusable Medical Devices

    • Historical Version
  11. CSA Z314.0-13


    Medical device reprosessing - General requirements

    • Historical Version
  12. CSA Z314.23-12


    Chemical sterilization of reusable medical devices in health care facilities

    • Historical Version
  13. CSA Z314.22-10 (R2015)


    Management of loaned, reusable medical devices, Includes Update No. 1 (2011)

    • Historical Version
  14. CSA Z314.14-10 (R2015)


    Selection and Use of Rigid Sterilization Containers

    • Historical Version
  15. CAN/CSA Z314.10.2-10 (R2015)


    Laundering, maintenance, and preparation of multiple-use gowns, drapes, and wrappers in health care facilities

    • Historical Version
  16. CAN/CSA Z314.10.1-10 (R2015)


    Selection and use of gowns, drapes, and wrappers in health care facilities

    • Historical Version
  17. CAN/CSA Z314.15-10 (R2015)


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

    • Historical Version
  18. CSA Z314.3-09 (R2014)


    Effective sterilization in health care facilities by the steam process

    • Historical Version
  19. CAN/CSA Z314.8-08 (R2013)


    Decontamination of Reusable Medical Devices

    • Historical Version
  20. CAN/CSA Z314.14-04


    Selection and Use of Rigid Sterilization Containers

    • Historical Version
  21. CAN/CSA Z314.22-04

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    Management of Loaned, Shared, and Leased Medical Devices, Includes Update No. 1 (2006)

    • Historical Version
  22. CAN/CSA Z314.15-03 (R2008)


    Warehousing, Storage, and Transportation of Clean and Sterile Medical Devices

    • Historical Version
  23. CAN/CSA Z314.10-03 (R2008)


    Selection, Use, Maintenance, and Laundering of Reusable Textile Wrappers, Surgical Gowns, and Drapes for Health Care Facilities

    • Historical Version
  24. CAN/CSA Z314.3-01 (R2006)


    Effective Sterilization in Health Care Facilities by the Steam Process

    • Historical Version
  25. CAN/CSA Z314.8-00 (R2005)


    Decontamination of Reusable Medical Devices

    • Historical Version
  26. CAN/CSA Z314.10-97


    Selection, Use, Maintenance and Laundering of Reusable Textile Wrappers, Surgical Gowns and Drapes for Health Facilities

    • Historical Version
  27. CSA Z314.14-93 (R1999)


    Selection and Use of Rigid Sterilization Containers

    • Historical Version
  28. CAN/CSA Z314.3-M91


    Effective Sterilization in Hospitals by the Steam Process

    • Historical Version