Language:
    • Available Formats
    • Options
    • Availability
    • Priced From ( in USD )
    • Printed Edition
    • Ships in 1-2 business days
    • $128.00
    • Add to Cart
    • Printed Edition + PDF
    • Immediate download
    • $170.00
    • Add to Cart

Customers Who Bought This Also Bought

 

About This Item

 

Full Description

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 History

  1. ISO 11607-2:2019

    👀currently
    viewing


    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes

    • Most Recent
  2. ISO 11607-2:2006


    Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes

    • Historical Version
  3. ISO 11607:2003


    Packaging for terminally sterilized medical devices

    • Historical Version