Industry News: CSA Publishes New Standard on Chemical Sterilization
The Canadian Standards Association (CSA) has just published its new standard “Chemical Sterilization of Reusable Medical Devices in Healthcare Facilities” Z314.23-12, available from either CSA or the American National Standards Institute.
CSA Describe the new Standard as follows
This is the first edition of CSA Z314.23, Effective chemical sterilization in healthcare facilities. It is one of a series of CSA Standards dealing with the safe and effective sterilization of medical supplies and equipment. It supersedes CAN/CSA-Z314.2, Effective sterilization in healthcare facilities by the ethylene oxide process, published in 2009, 2001, 1991, 1984, and 1977.
This Standard specifies essential elements in implementing a program for using chemicals to sterilize medical devices in health care facilities. Such chemicals can be vapour, gaseous, or liquid and are delivered in validated concentrations and quantities in defined sterilizers.
The body of this Standard contains requirements that are common to all chemical sterilization processes, whereas requirements specific to a particular chemical sterilization technology are contained in Annexes A to E.
The following chemical sterilants are currently approved for use in sterilizers in Canada and are addressed in this Standard:
(a) gaseous and vapour chemicals:
(i) ethylene oxide;
(ii) hydrogen peroxide;
(iii) ozone; and
(iv) hydrogen peroxide-ozone; and
(b) liquid chemicals: peracetic acid.
Exposure to chemical sterilants can present risks to health care personnel and patients; this Standard includes measures to minimize the risk of such exposure as well as discharge to the environment of sterilizing chemicals and by-products.
Further details are available at CSA’s website.