Packaging - Related International Standards
The following non-harmonised international standards are related to Packaging for EU MDR compliance reference.
| Standard | Title | Status | GSPRs | Link |
|---|---|---|---|---|
| ASTM F1980-21 | Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices | active | 11 | Link |
| ASTM D4169-23e1 | Standard Practice for Performance Testing of Shipping Containers and Systems | active | 11, 14 | Link |
| ASTM F2825-18(2026) | Standard Practice for Climatic Stressing of Packaging Systems for Single Parcel Delivery | active | 11 | Link |
| ASTM D4332-22 | Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing | active | 11 | Link |
| ASTM F2095-07(2021) | Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates | active | 11 | Link |
| ISO 11607-1:2019/Amd 1:2023 | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems | active | 11 | Link |
| ISO 11607-2:2019/Amd 1:2023 | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes | active | 11 | Link |