Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization PDF Download
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Author:
Publisher:
ISBN:
Category : Medical equipment
Languages : en
Pages :
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Author:
Publisher:
ISBN:
Category : Medical equipment
Languages : en
Pages :
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Book Description
Author: Anne F. Booth
Publisher: CRC Press
ISBN: 9781566767569
Category : Medical
Languages : en
Pages : 142
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Book Description
Stringent regulations require you to validate sterilization processes and step-by-step guidelines are needed to develop and implement a suitable validation program. Sterilization Validation and Routine Operation Handbook: Ethylene Oxide is the best practical guide available for the validation of EtO process. The information provided complies with ANSI/AAMI/ISO 11135: 1994, Medical devices-Validation and routine control of ethylene oxide sterilization which is based on a standard developed by the European Standardization Committee (CEN) entitled EN 550, Sterilization of medical devices- Validation and routine control of ethylene oxide sterilization. The text defines methods to assist you in the interpretation and understanding of the requirements in the standard and offers logical procedures for the validation and routine monitoring of your specific ethylene oxide process.
Author: British Standards Institute Staff
Publisher:
ISBN: 9780580232015
Category : Standards
Languages : en
Pages : 32
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Book Description
Medical equipment, Sterilization (hygiene), Ethylene oxide, Hygiene, Medical instruments, Sterile equipment, Performance, Performance testing, Quality control, Maintenance, Acceptance (approval), Specimen preparation, Test equipment
Author: British Standards Institute Staff
Publisher:
ISBN: 9780580749124
Category :
Languages : en
Pages : 94
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Book Description
Medical equipment, Sterilization (hygiene), Ethylene oxide, Hygiene, Medical instruments, Sterile equipment, Performance, Performance testing, Quality control, Maintenance, Acceptance (approval), Verification, Microbiological analysis, Instructions for use, Personnel, Sterilizers, Management
Author: Anne F Booth
Publisher: CRC Press
ISBN: 1351357565
Category : Medical
Languages : en
Pages : 160
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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: British Standards Institute Staff
Publisher:
ISBN: 9780580508806
Category :
Languages : en
Pages : 54
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Book Description
Medical equipment, Sterilization (hygiene), Ethylene oxide, Hygiene, Medical instruments, Sterile equipment, Performance, Performance testing, Quality control, Maintenance, Acceptance (approval), Verification, Microbiological analysis, Instructions for use, Personnel, Sterilizers, Management
Author: American National Standards Institute
Publisher:
ISBN: 9781570200151
Category : Medical instruments and apparatus
Languages : en
Pages : 20
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Book Description
Author: Association for the Advancement of Medical Instrumentation
Publisher:
ISBN:
Category : Sterilization
Languages : en
Pages : 12
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Book Description
Author:
Publisher:
ISBN: 9781570202865
Category : Ethylene oxide
Languages : en
Pages :
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Book Description
Author: Standards Australia (Organization)
Publisher:
ISBN: 9780733779176
Category : Medical instruments and apparatus
Languages : en
Pages : 38
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Book Description
