AAMI/ISO TIR17665-3:2014/(R)2016

This Technical Specification provides guidance about the attributes of a medical device to be considered by the user when assigning a medical device to a product family for the purpose of identifying and aligning it to a processing category for a specific moist heat sterilization process. In this part of ISO 17665 the attributes which relate to efficient sterilization and which are used to identify a product family have been selected from operational experience, engineering considerations and experimental data relating to the efficacy of the different types of moist heat sterilizers and their sterilization processes, and the types and design of differing medical devices and sterile barrier systems and/or packaging systems. Medical devices that are labelled by the manufacturer as being capable of being sterilized via moist heat may be categorized into product families by a user. However, not all medical devices will fit into one of the product families described in this part of ISO 17665. In these cases, new product families will need to be identified based on the consideration of the products attributes and require additional performance qualification. Annex 3