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Sterilization Validation and Routine Operation Handbook (2001)

Radiation

Paperback Engels 2019 1e druk 9781138561939
Verwachte levertijd ongeveer 11 werkdagen

Samenvatting

The validation and radiation sterilization process for biomaterials and medical devices requires careful planning to ensure regulatory compliance followed by precise accuracy in execution and documentation. This in-depth guide details all steps from prevalidation planning to final report and ongoing monitoring and control. Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. The guidance presented complies with ANSI/AAMI/ISO 11137: 1994, Sterilization of health care product-Requirements for validation and routine control-Radiation sterilization and the newly published AAMI substantiation of 25 kGy using VDmax procedure. The author discusses methods to aid in comprehending the requirements in these standards. She also provides practical procedures for the validation and routine monitoring and control of specific gamma and electron beam radiation sterilization processes.

Specificaties

ISBN13:9781138561939
Taal:Engels
Bindwijze:Paperback
Aantal pagina's:170
Uitgever:CRC Press
Druk:1

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        Sterilization Validation and Routine Operation Handbook (2001)