What is ISO/TS 16775 about?
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:
- Does not add to, or otherwise change, the requirements of ISO 116071 and ISO 116072
- Does not include requirements to be used as basis of regulatory inspection or certification assessment activities.
- Does not provide guidance for applications of packaging materials and systems after their opening.
Who is ISO/TS 16775 for?
ISO/TS 16775 on packaging for terminally sterilized medical devices is applicable to:
- Healthcare facilities
- Medical device manufacturers
- Healthcare scientists
- Doctors and healthcare professionals
- Medical device reprocessors
Why should you use ISO/TS 16775?
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.
What’s changed since the last update?
PD CEN ISO/TS 16775:2021, supersedes PD CEN ISO/TS 16775:2014, which is withdrawn.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:
- Clause normative references have been added
- Clause 3 “Terms and definitions” has been updated
- Structural adaptation of the text to the structure of ISO 116071:2019 and ISO 116072:2019
- Updates to reflect current editions of ISO 116071:2019 and ISO 116072:2019
- Intent and guidance is provided for each clause of the standard to improve the usability of this document