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About This Item

 

Full Description



1. Scope

1.1
This Standard outlines essential elements in a program for using steam to sterilize medical devices in health care facilities, with the object of achieving an adequate level of sterility assurance and minimizing the risk of injury to the operators of steam sterilization equipment.
Notes:
(1) The term "health care facilities" includes, but is not limited to, hospitals, nursing homes, extended-care facilities, clinics, medical and dental offices, and health units in industry.
(2) Figure 1 shows the scope of this Standard within the reprocessing of reusable medical devices.
(3) Comprehensive guidance for small, office-based facilities can be found in CSA Special Publication PLUS 1112.

1.2
This Standard includes requirements for
(a) work areas;
(b) personnel qualifications and training;
(c) preparation and packaging of medical devices requiring sterilization;
(d) sterilizer loading and operation;
(e) storage of sterilized medical devices;
(f) sterility assurance, including test pack construction and use;
(g) product evaluation for sterilizable medical devices and packaging materials; and
(h) maintenance and sterilizer quality assurance.

1.3
This Standard does not apply to
(a) emergency (flash) sterilization;
Note: See CSA Standard Z314.13.
(b) construction and performance of steam sterilizers;
Note: See CSA Standard CAN/CSA-Z314.7.
(c) washer/sterilizers; or
(d) decontamination of reusable medical devices prior to sterilization.
Note: See CSA Standard Z314.8.

1.4
In this Standard, "shall" indicates a mandatory requirement; "should" indicates a recommendation or that which is advised but not mandatory; and "may" indicates an advisory or optional statement. Notes accompanying clauses do not include mandatory or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material that is not properly a part of the Standard. Notes to figures and tables are considered part of the figure or table and may be written as mandatory requirements; legends to figures are also considered part of the requirements of the figure.
 

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


    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)

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    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