Sterilization Validation and Routine Operation Handbook (2001) - Radiation (Paperback)

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.

General

Imprint:	Crc Press
Country of origin:	United Kingdom
Series:	CRC Press Revivals
Release date:	2019
First published:	2001
Authors:	Anne Booth
Format:	Paperback
Pages:	170
ISBN-13:	978-1-138-56193-9
Categories:	Books > Medicine > Surgery > Surgical techniques Books > Law > Laws of other jurisdictions & general law > Social law > General Books > Medicine > General issues > Medical equipment & techniques > Medical laboratory testing & techniques
LSN:	1-138-56193-2
Barcode:	9781138561939

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