Sterilization of Health Care Products-Requirements for the Development, Validation, and Routine Control of an Industrial Sterilization Process for Medical Devices-Dry Heat PDF Download
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Author: Association for the Advancement of Medical Instrumentation
Publisher:
ISBN: 9781570201905
Category :
Languages : en
Pages :
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Author: Association for the Advancement of Medical Instrumentation
Publisher:
ISBN: 9781570201905
Category :
Languages : en
Pages :
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Book Description
Author: American National Standards Institute
Publisher:
ISBN: 9781570204180
Category : Disinfection and disinfectants
Languages : en
Pages : 62
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Book Description
Author: British Standards Institute Staff
Publisher:
ISBN: 9780580779336
Category :
Languages : en
Pages : 74
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Book Description
Sterilization (hygiene), Sterile equipment, Sterilizers, Medical equipment, Medical instruments, Process control, Quality control, Verification
Author: Technical Committee ISO/TC 198, Sterilization of Health Care Products
Publisher:
ISBN:
Category : Ethylene oxide
Languages : en
Pages : 78
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Book Description
Author:
Publisher:
ISBN: 9781570202537
Category : Medical instruments and apparatus
Languages : en
Pages :
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Author: Anne F Booth
Publisher: CRC Press
ISBN: 1351357565
Category : Medical
Languages : en
Pages : 155
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Book Description
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.
Author:
Publisher:
ISBN: 9788325105785
Category :
Languages : en
Pages : 40
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Author: Singapore Standards Council
Publisher:
ISBN: 9789814835534
Category : Standardization
Languages : en
Pages : 77
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Author:
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages :
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Author: Standards Australia (Organization)
Publisher:
ISBN: 9780733779176
Category : Medical instruments and apparatus
Languages : en
Pages : 38
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Book Description
