Author: Association for the Advancement of Medical Instrumentation
Publisher:
ISBN: 9781570201592
Category : Equipment and Supplies
Languages : en
Pages : 15

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Book Description

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: Anne F Booth
Publisher: CRC Press
ISBN: 1351357573
Category : Medical
Languages : en
Pages : 170

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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:
Category :
Languages : en
Pages :

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Book Description

Author: International Organization for Standardization
Publisher:
ISBN:
Category : Medical instruments and apparatus
Languages : en
Pages : 12

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Book Description

Author: Barry P. Fairand
Publisher: CRC Press
ISBN: 1482286203
Category : Medical
Languages : en
Pages : 154

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Book Description
Focusing on how the radiation process works and how it is applied in sterilizing medical devices and healthcare products, Radiation Sterilization for Health Care Products covers recent developments in radiation technology such as e-beams, gamma rays, and x-rays. The author discusses the design and operation of irradiators as well as factors that affect cost and efficiency. He offers readers practical insights on this critical step in healthcare product manufacturing, its current uses, and its related cost concerns. Authortitative and comprehensive, the book brings togehter information scattered throughout the literature into one convenient resource.

Author: Barry P. Fairand
Publisher: CRC Press
ISBN: 9781587160745
Category : Technology & Engineering
Languages : en
Pages : 162

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Book Description
Focusing on how the radiation process works and how it is applied in sterilizing medical devices and healthcare products, this book provides the latest developments in radiation technology in the form of e-beams, gamma rays, and x-rays. It covers the design and operation of irradiators as well as factors that affect cost and efficiency. It offers readers practical insights on this critical step in healthcare product manufacturing, its current uses, and its related cost concerns. Bringing all the information into one source, Radiation Sterilization for Health Care Products is a uniquely comprehensive resource.

Author: British Standards Institute Staff
Publisher:
ISBN: 9780580851520
Category :
Languages : en
Pages : 68

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Book Description
Sterilization (hygiene), Health services, Products, Radiation, Microorganisms, Medical equipment, Verification, Medical technology

Author:
Publisher:
ISBN: 9781488306242
Category : Medical instruments and apparatus
Languages : en
Pages : 68

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Book Description
This part of ISO 11137 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose.This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit.

Author: Aziz Nather
Publisher: World Scientific
ISBN: 9812705902
Category : Science
Languages : en
Pages : 584

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Book Description
This important book discusses the need for gamma irradiation in the processing of tissue allografts. With particular emphasis on tissue banking in the Asia-Pacific region, it covers a wide range of issues in tissue banking, including the basic science of radiation, quality control of the irradiation process, and clinical applications of irradiated bone grafts and amnions. A compulsory textbook for the well-regarded Singapore-based IAEA/NUS Diploma Course in Tissue Banking, it is also a useful guide for tissue bankers in establishing quality systems in their banks. Whether they be tissue banking students, tissue graft producers, radiation scientists, or transplantation surgeons, readers of this book will discover the latest developments in this exciting interdisciplinary field.