ISO 11607-2:2019
p
ISO 11607-2:2019
70800

Abstract

 Preview

This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.

It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.


General information 

  •  :  Published
     : 2019-02
  •  : 2
     : 13
  •  : ISO/TC 198 Sterilization of health care products
  •  :
    11.080.30 Sterilized packaging

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal:

Buy this standard

en
Format Language
std 1 88 PDF + ePub
std 2 88 Paper
  • CHF88

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.