Overview
EN ISO 11607-1:2020/A1:2023 is the CEN-endorsed amendment to ISO 11607‑1 that integrates the application of risk management into requirements for packaging of terminally sterilized medical devices. The standard covers requirements for materials, sterile barrier systems (SBS) and complete packaging systems, and links packaging design, testing and validation to a risk‑based approach. This amendment was approved by CEN in 2023 and supports conformity to EU medical device regulations when cited (see Annex ZA/ZB).
Key topics and requirements
- Scope: Requirements for materials, SBS and packaging systems used to maintain sterility from sterilization to point of use.
- Risk management application: Explicit direction to apply established risk management processes to packaging design, testing and validation (aligning with MDR 2017/745 and IVDR 2017/746 expectations where applicable).
- Performance and stability testing: Packaging performance, sterile barrier system integrity and stability testing are required to demonstrate maintenance of sterility.
- Material and process qualification: Qualification of materials and systematic design measures to reduce risk are emphasized.
- Usability and aseptic presentation: Packaging design must consider user/environment factors; packaging usability evaluation supports aseptic presentation requirements.
- Validation linkage: References and normative linkage to EN ISO 11607‑2 for forming, sealing and assembly process validation.
- Regulatory alignment: Annex ZA/ZB map clauses to General Safety and Performance Requirements (GSPRs) of EU Regulation (EU) 2017/745 and 2017/746 and detail where coverage is partial or not applicable.
Note: the amendment clarifies what packaging topics are covered and where limitations exist (for example, benefit–risk assessments for the medical device itself are outside the scope of packaging standards).
Practical applications
- Design and development of sterile packaging and sterile barrier systems for single‑use and reusable medical devices.
- Packaging material selection, qualification and supplier control.
- Development of packaging validation protocols (performance, stability, integrity) and alignment with forming/sealing validation per EN ISO 11607‑2.
- Preparing technical documentation to support regulatory submissions and demonstrating presumption of conformity to MDR/IVDR when the standard is cited.
- Supporting post‑market surveillance and change control where packaging-related risks are re‑assessed.
Who should use this standard
- Medical device manufacturers and packaging designers
- Sterilization engineers and process validation teams
- Quality assurance, regulatory and risk management professionals
- Notified bodies and conformity assessment teams
- Packaging material suppliers and contract manufacturers
Related standards
- EN ISO 11607‑2 (Validation requirements for forming, sealing and assembly processes) - normative companion document.
- Referenced material test standards (e.g., ISO paper/board air permeance standards) as listed in the standard’s normative references.
Keywords: EN ISO 11607-1:2020/A1:2023, packaging for terminally sterilized medical devices, sterile barrier systems, risk management, medical device packaging standard, packaging validation, EN ISO 11607-2, MDR 2017/745.