Sterilization Validation and Routine Operation Handbook (2001) : Radiation
by
Anne Booth
Book Details
Format
Paperback / Softback
ISBN-10
1138561932
ISBN-13
9781138561939
Publisher
Taylor & Francis Ltd
Imprint
CRC Press
Country of Manufacture
GB
Country of Publication
GB
Publication Date
Jan 28th, 2019
Print length
170 Pages
Weight
226 grams
Product Classification:
Regulation of medicines & medical devices Medical laboratory testing & techniques Surgical techniques
Ksh 7,550.00
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An in-depth, one-source guide and reference, Sterilization Validation & Routine Operation Handbook: Radiation provides a framework for the validation and routine operation of an irradiation sterilization process. All steps from pre-validation planning to final report and ongoing monitoring and control are covered in detail.
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.
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