🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
ISO/TS 16775:2014

ISO/TS 16775:2014

$55.25

Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2

Published By Publication Date Number of Pages
ISO 2014-05 122
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Categories: ,

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

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.

Related products

ISO/TS 16775:2014
$55.25