Home

ISO/TS 16775:2014
Subscribe to updates

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

Abstract

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.

 

  • Edition: 1 (Monolingual) ICS: 11.080.30
    Status: Published Stage: 60.60 (2014-05-09)
    TC/SC: ISO/TC 198 Number of Pages: 115
  • No revision information available

  • No corrigenda or amendments available

Related standards

Format
  • PDF

    This format preserves the paper layout, and is watermarked

  • EPUB

    This format allows documents to be read on tablets and smartphones

  • COLOUR PDF

    Enhanced user-friendly colour PDF format

  • REDLINE

    See any updates made from previous versions at a glance

  • PAPER

    Normally A4 size documents. Shipping costs apply

Language

+

PDF + ePub
Paper

Swiss francs CHF 198

Add to basket

Got a question?

Check out our FAQs

Email customer services
or call us on +41 22 749 08 88
09:00 – 12:30, 14:00 – 17:00 (UTC+1).