ISO 11137-1 radiation sterilization readiness grid
Self-assessment of a radiation sterilization process per ISO 11137-1:2025 (development, validation, routine control).
Available (Edition 2025)
ISO 11137-1:2025
FormatExcel (.xlsx)
$0Free
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What this resource includes
The 43 requirements across 9 sections (QMS, sterilizing agent, process and equipment, product, dose, validation, routine control, release, maintaining effectiveness).
A conformity scale with rate and dashboard computed automatically.
Covers dose setting, dose mapping and IQ, OQ, PQ qualification (with ISO 11137-2 and ISO 11137-3).
Original HEMC content, no reproduction of the normative text.
HEMC methodological reference. It does not replace a full reading of the standard or tailored support.