CSA Z314.3 Effective Sterilization in Health Care Settings by the Steam Process (sixth edition)

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Dear Stakeholder:

CSA Z314.3 Effective sterilization in health care settings by the steam process (sixth edition) is a new edition draft Standard under development. The draft specifies essential elements for using steam to sterilize medical devices in health care settings, with the object of achieving an adequate level of sterility assurance and minimizing the risk of injury to health care setting personnel and patients.

This standard is one of a series of standards to be used in conjunction with CSA Z314.0-13, Medical device reprocessing – General requirements, which provides a framework to establish, document and maintain requirements for the reprocessing of medical devices as part of a quality management system. CSA Z314.3 is intended to provide requirements for the safe and reliable steam sterilization of reusable medical devices, water and steam quality, and extended steam sterilization cycles. It is now available for public review and comment from November 19, 2013 – January 20, 2014 on the CSA Public Review Site (publicreview.csa.ca).

Once on the CSA Public Review Site, please use the search bar to find ‘Z314.3' or alternatively select the industry heading "Health Care and Medical Devices" and browse for Z314.3. Click on "Draft Details" to see the draft's scope but you will need a user id and password to read and comment on the entire document. If you don't have a user id and password, please register using the "Register" button on the login and registration screen.

For any questions, please contact the CSA Project Manager: Cathryn Cortissoz at cathryn.cortissoz@csagroup.org.