DIN CEN ISO/TS 16775:2014-10

This document (CEN ISO/TS 16775:2013) has been prepared by Technical Committee ISO/TC 198 "Sterilisation of health care products", in collaboration with Technical Committee CEN/TC 102 "Sterilizers and associated equipment for processing of medical devices", the secretariat of which is held by DIN. This document provides guidance for the application of the requirements contained in ISO 11607 1 and ISO 11607 2. This document does not add to, or otherwise change, the requirements of ISO 11607 1 and ISO 11607 2. This is an informative document, not normative. This document does not include requirements to be used as basis of regulatory inspection or certification assessment activities. This guidance can be used to better understand the requirements of ISO 11607 1 and/or ISO 11607 2 and illustrates some of the variety of methods and approaches available for meeting the requirements of those International Standards. It is not required that this document be used to demonstrate compliance with them. This document contains guidelines for evaluation, selection and use of packaging materials, preformed sterile barrier systems, sterile barrier systems and packaging systems. Guidance on validation requirements for forming, sealing and assembly processes is also given. This document provides information for health care facilities (see Clause 3) and for the medical devices industry (see Clause 4).