Endoscope manufacturers and health care facilities are under increased scrutiny from regulatory bodies, including the US FDA. It is essential that both manufactures and end users understand the increasing requirements enacted to improve patient safety.
ANSI/AAMI/ISO 11135:2014 Annex E recently underwent revision expanding on the requirements for the release of product from a single batch Ethylene Oxide (EO) sterilization process.
Product family grouping is discussed in Clause 4 of ANSI/AAMI/ISO 11137-2:2013 entitled ‘Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose’.
We use cookies to improve your site experience, assess usage of the site, and to support the marketing of our services. For information about how to set cookie preferences, please visit our Cookie Policy. If you agree to our use of cookies press “I Agree”, or continue to use our site, which will be considered consent. I AgreeCookie Policy
