DIN CEN ISO/TS 16775 DIN SPEC 58997:2014-10

This Technical Specification provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2. It does not add to, or otherwise change, the requirements of ISO 11607-1 and/or ISO 11607-2. This Technical Specification 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 to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 11607-1 and/or ISO 11607-2. This document provides guidelines for evaluation, selection and use of packaging materials, preformed sterile barrier systems, sterile barrier systems and packaging systems. It also provides guidance on validation requirements for forming sealing and assembly processes. This document is applicable to health care facilities (see clause 3) and to the medical devices industry (see clause 4). This document provides no guidelines for applications of packaging materials and systems after their opening. In the use of packaging for other purposes such as a 'sterile field' or transport of contaminated items, other regulatory standards will apply.