Sterilization Validation and Routine Operation Handbook (2001)

Radiation

Nonfiction, Health & Well Being, Medical, Medical Science, Pharmacology
Cover of the book Sterilization Validation and Routine Operation Handbook (2001) by Anne F Booth, CRC Press
View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart
Author: Anne F Booth ISBN: 9781351357562
Publisher: CRC Press Publication: November 22, 2017
Imprint: CRC Press Language: English
Author: Anne F Booth
ISBN: 9781351357562
Publisher: CRC Press
Publication: November 22, 2017
Imprint: CRC Press
Language: English

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.

Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook: Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

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.

Background chapters provide needed information on radiation sterilization technologies, sterilization microbiology, validation approaches and working with a radiation sterilization contractor. Much of the information in this new book is presented in convenient tables and charts, with diagrams and other schematics that simply illustrate appropriate validation methodologies. Sterilization Validation & Routine Operation Handbook: Radiation brings together in one resource information scattered throughout many documents and will be useful to all those involved in the sterilization of medical materials, drugs and devices.

More books from CRC Press

Cover of the book Two- and Three-Dimensional Flow of Groundwater by Anne F Booth
Cover of the book Contract Practice for Surveyors by Anne F Booth
Cover of the book Ergonomics in Action by Anne F Booth
Cover of the book Biohydrometallurgical Recycling of Metals from Industrial Wastes by Anne F Booth
Cover of the book Magnesium Alloys as Degradable Biomaterials by Anne F Booth
Cover of the book Tribosystem Analysis by Anne F Booth
Cover of the book Emergency Medicine by Anne F Booth
Cover of the book Monotone Iterative Techniques for Discontinuous Nonlinear Differential Equations by Anne F Booth
Cover of the book Carbon-Neutral Architectural Design by Anne F Booth
Cover of the book Graphical Methods for Data Analysis by Anne F Booth
Cover of the book Public Private Partnerships in International Construction by Anne F Booth
Cover of the book Understanding Human Error in Mine Safety by Anne F Booth
Cover of the book Simplifying Perspective by Anne F Booth
Cover of the book Pathology Of Aging Rats by Anne F Booth
Cover of the book High Performance Liquid Chromatography in Pesticide Residue Analysis by Anne F Booth
We use our own "cookies" and third party cookies to improve services and to see statistical information. By using this website, you agree to our Privacy Policy