Abstract Preview

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.


General information

  • Status :  Published
    Publication date : 2014-05
  • Edition : 1
    Number of pages : 115
  • :
    ISO/TC 198
    Sterilization of health care products
  • 11.080.30
    Sterilized packaging

Buy this standard

Format Language
PDF + ePub
Paper
PDF
  • CHF198

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

Keep up to date with ISO

Sign up to our newsletter for the latest news, views and product information