Standard

ISO 11607-2:2019

Historical draft

Note: This standard has a new edition: ISO 11607-2:2019

Preview

Corrigendums and amendments are bought separately.

Language
Services

Abstract

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.

Document information

  • Standard from ISO
  • Published:
  • Expires:
  • Edition: 2
  • Version: 1
  • Document type: IS
  • ICS 11.080.30
  • ISO TC ISO/TC 198

Product Relations

Product life cycle