ISO/TS 16775 is an informative document, not normative. ISO/TS 16775 provides guidance for the application of the requirements contained in ISO 116071 and ISO 116072.
Guidelines provided in ISO/TS 16775 can be used to better understand the requirements of ISO 116071 and ISO 116072 and illustrates 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 conformity with them.
Guidelines provided in ISO/TS 16775 for evaluation, selection and use of packaging materials, preformed sterile barrier systems, sterile barrier systems and packaging systems and guidance on validation requirements for forming, sealing and assembly processes are also given.
Note: This standard does not cover:
ISO/TS 16775 on packaging for terminally sterilized medical devices is applicable to:
Guidelines of ISO/TS 16775 helps for evaluation, selection and use of packaging materials, preformed sterile barrier systems, sterile barrier systems and packaging systems. This helps to produce safe and efficient packaging products for terminally sterilized medical devices.
The requirements outlined in ISO/TS 16775 are generic and applicable to healthcare facilities and wherever medical devices are packaged and sterilized.
PD CEN ISO/TS 16775:2021, supersedes PD CEN ISO/TS 16775:2014, which is withdrawn.
In comparison with the PD CEN ISO/TS 16775:2014, the following technical modifications have been made:
CENISO/TS 16775
ISO/TS 16775