Packaging for Terminally Sterilized Medical Devices — Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems
Specifies requirements and test methods for the materials, preformed sterile barrier systems, sterile barrier systems, and packaging systems that maintain the sterility of a terminally sterilized medical device until the point of use. Amendment 1:2023 adds Annexes F and G on the application of risk management to packaging.
What this does not cover
stated in the document's own scope- Covers the packaging (materials and sterile barrier systems); validation of the forming, sealing and assembly processes is ISO 11607-2.
- Applies to terminally sterilized devices; aseptically processed products are outside its scope.
- Specifies packaging requirements, not the sterilization process itself, which is governed by ISO 17665, ISO 11135, and related standards.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
ISO 11607-1 specifies the requirements and test methods for the packaging that keeps a terminally sterilized medical device sterile until it is used — the materials, preformed sterile barrier systems, sterile barrier systems, and the overall packaging system. It is concerned with the packaging design and material properties: the microbial barrier, compatibility with the chosen sterilization process, integrity through handling, distribution and storage, and the ability to present the device aseptically at the point of use. Part 1 addresses the packaging itself; its companion Part 2 covers validation of the forming, sealing and assembly processes. Amendment 1:2023 added Annexes F and G on the application of risk management to packaging decisions.
Scope & applicability
Medical-device manufacturers designing, validating, and controlling sterile packaging. Part 1 covers the packaging design and material requirements; Part 2 covers the validation of the forming, sealing, and assembly processes.
Legal basis & how it acquires force
ISO 11607-1 is a voluntary consensus standard, but it is a harmonised standard under EU medical-device legislation and is recognised by FDA, so conformance is the practical route to demonstrating that sterile packaging meets device regulatory requirements. It is applied within a manufacturer’s ISO 13485 quality system and ISO 14971 risk management. The current text is ISO 11607-1:2019 (second edition) as amended by Amendment 1:2023.
Document structure
| Part | Covers |
|---|---|
| Materials and pre-formed systems | Requirements for packaging materials and preformed sterile barrier systems, including microbial-barrier and compatibility properties |
| Sterile barrier and packaging systems | Requirements for the sterile barrier system and the protective packaging system as a whole |
| Performance and stability | Integrity, seal strength, aseptic presentation, and stability/shelf-life evidence |
| Information and evaluation | Documentation, labelling, and the evaluation/testing needed to demonstrate conformance |
| Risk management (Amd 1:2023) | Annexes F and G applying ISO 14971 risk-management concepts to packaging |
Key requirements
- Materials and sterile barrier systems that provide an adequate microbial barrier and are compatible with the sterilization process
- Sterile barrier system integrity maintained through handling, distribution, and storage to the point of use
- Aseptic-presentation capability so the device can be removed without contamination
- Documented design, evaluation, and stability/shelf-life evidence for the packaging system
- Application of risk management to packaging decisions (Amd 1:2023, Annexes F and G)
International alignment
ISO 11607-1 works with Part 2 (process validation) and sits alongside the sterilization-validation standards ISO 17665 (moist heat) and ISO 11135 (ethylene oxide): the packaging must be validated as compatible with the sterilization method those standards govern. Packaging decisions are made inside the ISO 14971 risk framework and the ISO 13485 quality system.
ISO 11607-1:2019: frequently asked questions
Quick answers to common questions about ISO 11607-1:2019.
What is the current version of ISO 11607-1?
ISO 11607-1:2019 (second edition), amended by Amendment 1:2023, which was published in September 2023 and added Annexes F and G on the application of risk management.
What is the difference between ISO 11607-1 and -2?
Part 1 sets the requirements for the packaging materials and sterile barrier systems; Part 2 sets the validation requirements for the forming, sealing and assembly processes that produce them.
Does ISO 11607-1 cover aseptically filled products?
No. It applies to terminally sterilized medical devices — those sterilized in their final packaging. Aseptically processed products fall outside its scope.