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- Gamma Irradiation Sterilization Validation Procedure | ISO 13485 | FDA QSR Compliant
Gamma Irradiation Sterilization Validation Procedure | ISO 13485 | FDA QSR Compliant
- ISO 11137 Compliant
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- MS Word Format
- Digital Content - Instant Download
Gamma Irradiation Sterilization Validation ProcedureThe Gamma Irradiation Sterilization Validation Procedure defines the process to validate and monitor medical device products sterilized by gamma radiation. The gamma sterilization validation procedure applies to all medical devices sterilized by gamma radiation per ISO 11137-1, ISO 11137-2 and ISO 11137-3.
Gamma Irradiation Sterilization Validation Procedure OverviewThe Gamma Irradiation Sterilization Validation Procedure includes instruction on dose mapping, bioburden, sample selection, sample item portion (SIP), microbiological testing, verification dose, confirmatory verification dose experiments, dose audits, dose augmentation, routine monitoring, and establishing product families.
The Gamma Irradiation Sterilization Validation Procedure applies to medical devices sterilized by gamma irradiation in accordance with ISO 11137. Gamma Irradiation Sterilization Validation Procedure ComplianceThe Gamma Irradiation Sterilization Validation procedure is ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO 11737, FDA QSR, and ISO 13485:2016 compliant.
To learn more about our Gamma Irradiation Sterilization Validation procedure contact us at [email protected]
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