Medical Device Sterilization Standards

Sterile medical device clause 3 20 of iso 13485 2016 states that sterility requirements of each medical device can be subject to applicable regulatory requirements.

Medical device sterilization standards.

However since 1950 there has been an increase in medical devices and instruments made of materials e g plastics that require low temperature sterilization. Most medical and surgical devices used in healthcare facilities are made of materials that are heat stable and therefore undergo heat primarily steam sterilization. For example a regulatory authority in the region in which you supply medical devices demands ethylene oxide sterilization for a specific medical device so you have to ensure. Hso s standards for the reprocessing and sterilization of reusable medical devices address the safe and effective reprocessing and sterilization of reusable 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 reprocessing and sterilization equipment.

A list of recognized sterilization standards appears at fda s center for devices and radiological health cdrh s web site. How steam sterilization works. Iso tc 198 wg 1 industrial ethylene oxide sterilization working group iso tc 198 wg 2 radiation sterilization working group iso tc 198 wg 3 moist heat sterilization working group iso tc 198 wg 4 biological indicators working group iso tc 198 wg 5 terminology working group iso tc 198 wg 6 chemical. Firms may elect to comply with these standards.

A consolidation of several previous standards ansi aami st79 2017 offers a comprehensive guide to steam sterilization and sterility assurance in health care facilities. Iso 11737 2 2009 specifies the general criteria for tests of sterility on medical devices that have been exposed to a treatment with the sterilizing agent reduced relative to that anticipated to be used in routine sterilization processing. However compliance to. Nothing can withstand extreme temperatures and bacteria is no exception.

For medical devices sterilization is unsurprisingly crucial to patient health. Also aami tir34 2014 r 2017 water for the reprocessing of medical devices. Please see ansi aami st79 2017 comprehensive guide to steam sterilization and sterility assurance in health care facilities for more information section 3 3 3 1 and annex m.