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| Clause | Title | What It Covers | | :--- | :--- | :--- | | 1 | Scope | Delineation of the standard's applicability | | 2 | Normative references | Other standards referenced (ISO 11137‑1/‑2, ISO/TS 13004, etc.) | | 3 | Terms, definitions and symbols | Essential dosimetry terminology | | 4 | Measurement of dose | Core principles of dose measurement | | 5 | Establishing the maximum acceptable dose | Determining the highest dose a product can tolerate | | 6 | Establishing the sterilization dose | Linking dosimetry to the methods in ISO 11137‑2 | | 7 | Installation qualification (IQ) | Verifying that dosimetry equipment is correctly installed | | 8 | Operational qualification (OQ) | Testing equipment under simulated production conditions | | 9 | Performance qualification (PQ) | Demonstrating that the process works with actual product loads | | 10 | Routine monitoring and control | Ongoing dose measurement during production | Iso 11137-3 Pdf Free Download
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ISO 11137-3 is part of the ISO 11137 series, which defines the requirements for validation, process control, and dosimetry for radiation sterilization of healthcare products. While sets the requirements for development and validation and ISO 11137-2 covers sterilization dose establishment, ISO 11137-3 acts as a guidance document for the, often complex, field of dosimetry . Core Focus of ISO 11137-3 This public link is valid for 7 days
Guidance on finding the upper limit of radiation a product can withstand before its materials degrade.
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For teams working under ISO 11137-3 parameters, execution relies on three primary pillars of dosimetry control:
Selecting, calibrating, and using systems to measure radiation doses accurately.
