ISO 13485 · Expert · 13 min lesson
Packaging design and material selection under ISO 11607-1 and sterile barrier systems
ISO 11607-1:2019 and Amendment 1:2023 clauses 4 to 8, ISO 13485:2016 clause 7.5.7, EU MDR Annex I section 11.4
What you will learn
- Distinguish sterile barrier system, protective packaging and packaging system, and explain how ISO 11607-1, ISO 13485 clause 7.5.7 and MDR Annex I section 11.4 fit together.
- Select materials and design a sterile barrier system from device, sterilisation, distribution and user requirements, including microbial barrier and aseptic presentation.
- Build a traceable selection rationale under the risk management amendment, control supplier changes and recognise a weak design record.
Key takeaways
- ISO 11607-1 sets requirements for materials, sterile barrier systems and packaging systems; part 2 covers validation of the forming, sealing and assembly processes.
- A sterile barrier system keeps the device sterile until use; protective packaging guards it in handling and distribution; together with labels they form the packaging system.
- Material choice starts from design inputs: device hazards such as sharp edges, the sterilisation method, shelf life, distribution and aseptic opening.
- A supplier datasheet is not proof; compatibility, microbial barrier and performance must be shown on the actual packaging system (ISO 11607-1 clauses 5 to 7).
- Amendment 1:2023 ties packaging decisions to risk management, and any change of film, supplier or design must go through change control and re-evaluation.
Free practice question
Veridian's supplier notifies a change of the pouch film coating to a lower cost adhesive. The datasheet values look the same, and the buyer proposes to accept it at once.
What should the quality system require?
Immediate acceptance because datasheet values match.
Not quite. Datasheet equality does not prove seal, ageing or sterilisation behaviour, so clause 7.5.7 is not met.
A documented impact assessment, and testing or revalidation where the change could affect the sterile barrier.
Correct. Clause 7.5.7 of ISO 13485 requires sterile barrier processes to be validated after changes, so an assessment is needed first.
Acceptance if the price falls by at least five percent.
Not quite. Price is not a criterion in ISO 11607-1 clause 5 or ISO 13485 clause 7.5.7.
Refusal of all supplier changes permanently.
Not quite. Changes are allowed; they must be assessed and controlled under ISO 13485 clause 7.4 and 7.5.7.
Key terms
- sterile barrier system: The minimum package that prevents ingress of microorganisms and allows aseptic presentation of the product at the point of use.
- protective packaging: Configuration of materials designed to prevent damage to the sterile barrier system and its contents until the point of use.
- packaging system: The combination of the sterile barrier system and protective packaging.
- preformed sterile barrier system: A sterile barrier system supplied partly assembled, such as a pouch or header bag, ready to be filled and closed.
- porous material: Material such as medical paper or nonwoven polyethylene that lets sterilant gas pass while holding back microorganisms.
- microbial barrier: The ability of a material or system to stop microorganisms reaching the contents, tested under ISO 11607-1 clause 5.
- aseptic presentation: Opening the package so the contents can be removed without contaminating them.
- ISO 11607: Two-part standard for packaging of terminally sterilised medical devices: part 1 design and materials, part 2 process validation.
Official sources
- ISO 11607-1:2019 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
- ISO 11607-2:2019 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
- ISO 13485:2016 Medical devices - Quality management systems
- Regulation (EU) 2017/745 on medical devices (MDR)
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.