CSA - CAN/CSA-Z314.5-88
Industrial Sterilization of Medical Devices by the Ethylene Oxide Process
|Publication Date:||1 April 1988|
This Standard defines essential elements in a sterility assurance program for medical devices.
Note: This Standard is intended to include the programs of all companies that
(a) produce medical devices to be sterilized by ethylene oxide whether by the producing firm or by another firm on a contractual basis, prior to their sale; and
(b) perform only sterilization services on a contractual basis.
This Standard has as its objectives the achievement of an adequate level of sterility assurance for a device and the reduction of the residual effect of ethylene oxide on the recipient of the device.
Note: In order to implement the requirements of this Standard, it Is recommended that company management take into account government statutes, regulations, and guidelines.
In order to achieve the objectives of Clause 1.2, this Standard includes requirements for
(a) the construction and maintenance of buildings and equipment;
(b) production procedures; and
(c) sterility assurance.
This Standard does not include requirements for construction and performance of ethylene oxide sterilizers.
Note: For the subject matter excluded by Clause 1.4, refer to CSA Standard Z314.1, Ethylene Oxide Sterilizers for Hospitals.
CAUTION: ETHYLENE OXIDE IS CONSIDERED TO BE A HEALTH HAZARD. ADEQUATE STEPS SHOULD BE TAKEN TO MINIMIZE OPERATOR EXPOSURE TO THIS MATERIAL (SEE APPENDIX B FOR EXPOSURE CONTROL GUIDELINES).