BS EN ISO 11607-1:2020

What is ISO 11607-1 - Sterilized medical devices about?

This is the first 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 11607-1:2020 looks at requirements for packaging materials, as well as sterile barrier systems and packaging systems.

Who is ISO 11607-1 - Sterilized medical devices 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 ISO 11607-1 - Sterilized medical devices?

The development and construction of packaging systems for terminally sterilized medical devices is complicated and critical to patient safety. BS EN ISO 11607-1:2020 specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems intended to maintain the sterility of terminally sterilized medical devices until the point of use.

Use of the standard:

• Supports compliance with the General Safety and Performance Requirements (GSPR) contained in the EU MDR[WT1] 
• 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 11607-1:2020 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

It does not describe a quality assurance system for control of all stages of manufacture. It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.

What has changed since the last update?

ISO 11607-1 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 1 include:

a)      Definitions have been aligned with the latest version of ISO 11139

b)     New requirements added for the evaluation of usability for aseptic presentation

c)      New requirements added for the inspection of sterile barrier system integrity prior to use

d)     A new subclause added with requirements for revalidation in line with ISO 11607-2

e)     Annex B updated and various national, international and European test methods added or deleted

f)       A new Annex D added with environmental considerations

g)      A new Annex E added with draft guidance on ways to differentiate a sterile barrier system from protective packaging