BS EN ISO 11607-2:2020

Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes

What is BS EN ISO 11607-2:2020 about?

This is the second of two international standards written to ensure that terminally sterilized medical device packaging allows sterilization, provides physical protection and maintains sterility to the point of use. BS EN ISO 11607-2:2020 looks at validation requirements for forming, sealing and assembly processes.

Who is BS EN ISO 11607-2:2020 for?

• Manufacturers of medical devices, including IVDs
• Manufacturers of packaging materials and packaging systems for sterile devices
• Healthcare facilities with in-house or contracted sterilization services

Why should you use BS EN ISO 11607-2:2020?

It 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.

Use of the standard:

• Supports compliance with the General Safety and Performance Requirements (GSPR) contained in the EU MDR
• Supports increased focus internationally on requirements for sterile barrier systems for sterile medical devices
• Tackles the usability of packaging as well as its physical and microbiological performance
• Promotes state of the art procedures

NOTE: BS EN ISO 11607-2:2020 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

What's new about BS EN ISO 11607-2:2020?

The standard was revised to harmonize with the General Safety and Performance Requirements (GSPR) contained in the EU MDR, which stipulate that a design allow for easy and safe handling and prevent microbial contamination, and that the integrity of that packaging is clearly evident to the final user.

Other changes to Part 2 include:

a) The addition of terms and definitions for 'process variable', 'process parameter' and 'monitoring of processes'

b) Alignment of various definitions with the latest version of ISO 11139

c) The terminology of 'critical' process parameters is discontinued

d) The concept of a process specification is introduced to include all elements required to manufacture a product that consistently meets specifications

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