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71 items

 Most recent

AAMI TIR104:2022

Guidance on transferring health care products between radiation sterilization sources

CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]

 Most recent

AAMI TIR29:2012 (R2017)

Guide for process characterization and control in radiation sterilization of medical devices

CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]

 Most recent

ASTM 52303-24e1

Standard Guide for Absorbed-Dose Mapping in Radiation Processing Facilities

CONTENT PROVIDER
ASTM International [astm]

 Most recent

AAMI TIR37:2013 (AAMI TIR 37:2013)

Sterilization of health care products-Radiation-Guidance on sterilization of biologics and tissue-based products

CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]

 Most recent

ONORM EN ISO 11137-2:2023

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

CONTENT PROVIDER
Austrian Standards Institute [on]

 Most recent

GB 16383-2014

Quality control for radiation sterilization of medical and hygienical products (TEXT OF DOCUMENT IS IN CHINESE)

CONTENT PROVIDER
CHINESE GB Standards [spc]

 Most recent

AAMI TIR35:2016 (R2021)

Sterilization of health care products - Radiation sterilization - Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits

CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]

 Most recent

ASTM 51649-22e1

Standard Practice for Electron Beam Radiation Processing at Energies Between 300 keV and 25 MeV

CONTENT PROVIDER
ASTM International [astm]

 Most recent

ASTM 51707-22e1

Standard Guide for Estimation of Measurement Uncertainty in Dosimetry for Radiation Processing

CONTENT PROVIDER
ASTM International [astm]

 Most recent

ASTM 51818-20e1

Standard Practice for Dosimetry in an Electron Beam Facility for Radiation Processing at Energies Between 80 and 300 keV

CONTENT PROVIDER
ASTM International [astm]

 Most recent

ASTM ISO/ASTM51649-22

Standard Practice for Electron Beam Radiation Processing at Energies Between 300 keV and 25 MeV

CONTENT PROVIDER
ASTM International [astm]

 Most recent

ASTM ISO/ASTM51707-22

Standard Guide for Estimation of Measurement Uncertainty in Dosimetry for Radiation Processing

CONTENT PROVIDER
ASTM International [astm]

 Most recent

ONORM EN ISO 11137-3:2017

Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)

CONTENT PROVIDER
Austrian Standards Institute [on]

 Most recent

ANSI/AAMI/ISO 13004:2022

Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD

CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]

 Most recent

AAMI TIR76:2021

Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose at a specified sterility assurance level: Method Vdmax SD-S

CONTENT PROVIDER
Association for the Advancement of Medical Instrumentation [aami]

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