Harmonised Standards — Sterilization & Packaging
Official Source: EC Health — Harmonised Standards | Based on CID (EU) 2021/1182 (consolidated) and amendment CID (EU) 2026/1231
Harmonised Standards List (7 standards)
| Standard | Title Summary | GSPR Reference | Status |
|---|---|---|---|
| EN ISO 11135:2014 + 2019 | Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) | GSPR 11 (Sterilization & packaging) | Current |
| EN ISO 11137-1:2015 + 2019 | Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) | GSPR 11 (Sterilization & packaging) | Current |
| EN ISO 11137-2:2015 + 2023 | Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013) | GSPR 11 (Sterilization & packaging) | Current |
| EN ISO 11607-1:2020 + 2023 | Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019) | GSPR 11 (Sterilization & packaging) | Current |
| EN ISO 11607-2:2020 + 2023 | Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019) | GSPR 11 (Sterilization & packaging) | Current |
| EN ISO 11737-1:2018 + 2021 | Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018) | GSPR 11 (Sterilization & packaging) | Current |
| EN ISO 11737-2:2020 | Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019) | GSPR 11 (Sterilization & packaging) | Current |