Harmonised Standards — Sterilization & Packaging
Official Source: EC Health — Harmonised Standards | Based on CID (EU) 2021/1182 (consolidated) and amendment CID (EU) 2026/193
Harmonised Standards List (21 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 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 |
| EN ISO 25424:2019 + 2022 | Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilisation process for medical devices (ISO 25424:2018) | 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 13408-6:2021 | Part 6: Isolator systems (ISO 13408-6:2021) | GSPR 11 (Sterilization & packaging) | Current |
| EN ISO 14160:2021 | Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020) | GSPR 11 (Sterilization & packaging) | Current |
| EN 285:2015+A1:2021 | Steam sterilizers - Large sterilizers | 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 13408-1:2024 | Part 1: General requirements (ISO 13408-1:2023) | GSPR 11 (Sterilization & packaging) | Current |
| EN 556-1:2024 | Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices | GSPR 11 (Sterilization & packaging) | Current |
| EN 556-2:2024 | Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices | GSPR 11 (Sterilization & packaging) | Current |
| EN 14180:2025 | Low temperature steam and formaldehyde sterilizers - Requirements and testing | GSPR 11 (Sterilization & packaging) | Current |
| EN ISO 7197:2024 | Sterile, single-use hydrocephalus shunts and components (ISO 7197:2024) | GSPR 11 (Sterilization & packaging) | Current |
| EN ISO 17665:2024 | Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024) | GSPR 11 (Sterilization & packaging) | Current |
| EN ISO 18562-1:2024 | Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2024) | GSPR 11 (Sterilization & packaging) | Current |
| EN ISO 18562-2:2024 | Part 2: Tests for emissions of particulate matter (ISO 18562-2:2024) | GSPR 11 (Sterilization & packaging) | Current |
| EN ISO 18562-3:2024 | Part 3: Tests for emissions of volatile organic compounds (VOCs) (ISO 18562-3:2024) | GSPR 11 (Sterilization & packaging) | Current |
| EN ISO 18562-4:2024 | Part 4: Tests for leachables in condensate (ISO 18562-4:2024) | GSPR 11 (Sterilization & packaging) | Current |