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ISO 11607-1:2006 Part 1:

Requirements for materials, sterile barrier systems and packaging systems

Due for publication in mid-2006

 

ISO 11607-1:2006 Part 2:

Validation requirements for forming, sealing and assembly processes

Due for publication in mid-2006

 

It is expected that the 2006 versions of ISO 11607 will include definitions of new terminology for packaging layers.

                                                                            

Summary of earlier version:

ISO 11607, Packaging for terminally sterilized medical devices.

Scope

·        Specifies the requirements for both single use and reusable containers.

• Outlines principal requirements for packaging process development and validation.
• Specifies requirements for essential criteria used to evaluate package performance.
• This standard does not necessarily apply to packaging for products manufactured aseptically where additional requirements to prevent product contamination apply.

Definitions: see Glossary

Note: Annexes to Standard contain test method details

Annex A

Test method for resistance of impermeable materials to the passage of air.

            Refers to ISO 5636-5, ISO 5636-2 and ISO 5636-1

Annex B

Evaluating package performance in distribution, storage and handling systems.

            Distribution System

                        Refers to ASTM D-4169, ISTA Procedures 1and 1A also ISTA Procedures 2and 2A

            Storage System

                        Refers to ASTM D-4332

            Handling System

Requires methodology for packaging to be documented and lists steps to be evaluated for any effects detrimental to the end product.

Annex C

Dye penetration test

            This test method is described in full.                                                                   Home