Medical Device Sterilization 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.

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. These tests are intended to be performed when defining validating or maintaining a sterilization process. 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. A list of recognized sterilization standards appears at fda s center for devices and radiological health cdrh s web site.

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. 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. 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 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.

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. Also aami tir34 2014 r 2017 water for the reprocessing of medical devices. How steam sterilization works. Nothing can withstand extreme temperatures and bacteria is no exception.

For medical devices sterilization is unsurprisingly crucial to patient health. 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. However compliance to.