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. However compliance to. 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.

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. Also aami tir34 2014 r 2017 water for the reprocessing of medical devices. Nothing can withstand extreme temperatures and bacteria is no exception. These tests are intended to be performed when defining validating or maintaining a sterilization process.

For ethylene oxide sterilization two voluntary consensus standards ansi aami iso 11135 2014 and ansi aami iso 10993 7 2008 r 2012 describe how to develop validate and control ethylene oxide. For the best results sterilization needs to begin with the manufacturers who make use of steam ethylene oxide radiation and other methods to assure the cleanliness of their products long before they are ever brought into use many of these sterilization techniques are addressed. 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. Firms may elect to comply with these standards.

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. A list of recognized sterilization standards appears at fda s center for devices and radiological health cdrh s web site. For medical devices sterilization is unsurprisingly crucial to patient health.