-
- Available Formats
- Options
- Availability
- Priced From ( in USD )
-
- Immediate download
- $250.00
- Add to Cart
-
- Printed Edition
- Ships in 1-2 business days
- $288.00
- Add to Cart
-
- Printed Edition + PDF
- Immediate download
- $437.00
- Add to Cart
Customers Who Bought This Also Bought
-
ISO 11607-1:2019
Priced From $200.00 -
ISO 11607-2:2019
Priced From $111.00 -
ISO/TS 16775:2021
Priced From $250.00
-
AAMI/ISO TIR16775:2014
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2- This is the most recent version of this document.
-
CAN/CSA-ISO/TS 16775:17
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (Adopted ISO technical specification 16775:2014, first edition, 2014-05-15)- This is the most recent version of this document.
-
BS PD CEN ISO/TS 16775:2014
Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2- Historical Version
About This Item
Full Description
ISO/TS 16775:2014 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. It is an informative document, not normative, and does not include requirements to be used as basis of regulatory inspection or certification assessment activities.
The 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 to be used to demonstrate compliance with them.
Guidelines are given 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.
ISO/TS 16775:2014 provides information for health care facilities and for the medical devices industry. It does not provide guidance 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.
Document History
-
ISO/TS 16775:2021
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2- Most Recent
-
ISO/TS 16775:2014
currently
viewing
Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2- Historical Version