Compliance auditISO 11137-1:2025
ISO 11137-1:2025 — Radiation sterilization of medical devices
Requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
- control points
- 56
- anchored clauses
- 25
- Clauses covered
- 8
Clauses covered
| Quality management system elements | 4 | 4.1 · 4.2 · 4.3 · 4.4 |
| Characterization of the sterilizing agent | 3 | 5.3 · 5.4 · 5.1-5.2 |
| Characterization of the process and equipment | 2 | 6.1 · 6.2 |
| Product definition | 1 | 7 |
| Process definition | 4 | 8.1 · 8.2 · 8.3 · 8.4 |
| Validation | 4 | 9.1 · 9.2 · 9.3 · 9.4 |
| Routine control and release | 2 | 10 · 11 |
| Maintaining process effectiveness | 5 | 12.1 · 12.2 · 12.3 · 12.4 · 12.5 |
Scale
CompliantOpportunity for improvementNon-compliantNot applicable
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