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Download or read book Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization written by and published by . This book was released on 1994 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : British Standards Institute Staff
Publisher :
ISBN 13 : 9780580232015
Total Pages : 32 pages
Book Rating : 4.2/5 (32 download)
Download or read book Sterilization of Medical Devices. Validation and Routine Control of Ethylene Oxide Sterilization written by British Standards Institute Staff and published by . This book was released on 1994-10 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical equipment, Sterilization (hygiene), Ethylene oxide, Hygiene, Medical instruments, Sterile equipment, Performance, Performance testing, Quality control, Maintenance, Acceptance (approval), Specimen preparation, Test equipment
Author : Anne F. Booth
Publisher : CRC Press
ISBN 13 : 9781566767569
Total Pages : 142 pages
Book Rating : 4.7/5 (675 download)
Download or read book Sterilization Validation and Routine Operation Handbook written by Anne F. Booth and published by CRC Press. This book was released on 1999-09-01 with total page 142 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Anne F Booth
Publisher : CRC Press
ISBN 13 : 1351357565
Total Pages : 160 pages
Book Rating : 4.3/5 (513 download)
Download or read book Sterilization Validation and Routine Operation Handbook (2001) written by Anne F Booth and published by CRC Press. This book was released on 2017-11-22 with total page 160 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 13 : 9780580508806
Total Pages : 54 pages
Book Rating : 4.5/5 (88 download)
Download or read book Sterilization of Health Care Products. Ethylene Oxide. Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices written by British Standards Institute Staff and published by . This book was released on 2007-06-29 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : British Standards Institute Staff
Publisher :
ISBN 13 : 9780580749124
Total Pages : 94 pages
Book Rating : 4.7/5 (491 download)
Download or read book Sterilization of Health-Care Products. Ethylene Oxide. Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices written by British Standards Institute Staff and published by . This book was released on 1914-07-31 with total page 94 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 13 : 9781570200151
Total Pages : 20 pages
Book Rating : 4.2/5 (1 download)
Download or read book Medical Devices written by American National Standards Institute and published by . This book was released on 1994-03 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Association for the Advancement of Medical Instrumentation
Publisher :
ISBN 13 :
Total Pages : 12 pages
Book Rating : 4.:/5 (114 download)
Download or read book Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices written by Association for the Advancement of Medical Instrumentation and published by . This book was released on 1981 with total page 12 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 : 9781570202865
Total Pages : pages
Book Rating : 4.2/5 (28 download)
Download or read book Sterilization of Health Care Products: Requirements for development, validation and routine control of a sterilization process for medical devices written by and published by . This book was released on with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Standards Australia (Organization)
Publisher :
ISBN 13 : 9780733779176
Total Pages : 38 pages
Book Rating : 4.7/5 (791 download)
Download or read book Sterilization of Health Care Products written by Standards Australia (Organization) and published by . This book was released on 2006-01-01 with total page 38 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Anne F Booth
Publisher : CRC Press
ISBN 13 : 1351357573
Total Pages : 170 pages
Book Rating : 4.3/5 (513 download)
Download or read book Sterilization Validation and Routine Operation Handbook (2001) written by Anne F Booth and published by CRC Press. This book was released on 2017-11-22 with total page 170 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Wayne J. Rogers
Publisher : iSmithers Rapra Publishing
ISBN 13 : 9781859574904
Total Pages : 344 pages
Book Rating : 4.5/5 (749 download)
Download or read book Sterilisation of Polymer Healthcare Products written by Wayne J. Rogers and published by iSmithers Rapra Publishing. This book was released on 2005 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sterilisation has always been challenging but sterilisation of healthcare products and polymers, especially together is an even greater challenge - how do you sterilise without adversely affecting the end use or the end user? This book discusses all the sterilisation methods used for polymeric healthcare products both traditional and new.
Author : Anne Booth
Publisher : Routledge
ISBN 13 : 1351413805
Total Pages : 380 pages
Book Rating : 4.3/5 (514 download)
Download or read book Sterilization of Medical Devices written by Anne Booth and published by Routledge. This book was released on 2018-12-12 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book presents vital information on international sterilization standards and guidance on practical application of these standards in the manufacturing process. It covers validation, industrial sterilization methods, emerging sterilization techniques, laboratory testing, manufacturing of sterile devices, and device reuse. Excerpted from The Validator, edited by Anne F. Booth, more than fifty experts share their knowledge of current technologies in easy-to-understand articles that establish methods to ensure compliance. Contents include reviews of ISO sterilization standards, industrial sterilization methods and technologies, and support testing methodologies.
Author : British Standards Institute Staff
Publisher :
ISBN 13 : 9780580232039
Total Pages : 16 pages
Book Rating : 4.2/5 (32 download)
Download or read book Sterilization of Medical Devices written by British Standards Institute Staff and published by . This book was released on 1994 with total page 16 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical equipment, Sterilization (hygiene), Steam, Verification, Quality control, Quality assurance, Certification (approval), Installation, Performance, Maintenance, Personnel, Medical instruments
Author : British Standards Institute Staff
Publisher :
ISBN 13 : 9780580232022
Total Pages : 34 pages
Book Rating : 4.2/5 (32 download)
Download or read book Sterilization of Medical Devices. Validation and Routine Control of Sterilization by Irradiation written by British Standards Institute Staff and published by . This book was released on 1994-11 with total page 34 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical equipment, Sterilization (hygiene), Dry sterilization, Gamma-radiation, Electron beams, Radiation, Radiation measurement, Verification, Quality control, Quality assurance, Medical technology, Process specification, Documents, Records (documents), Calibration, Maintenance, Medical instruments
Author : British Standards Institute Staff
Publisher :
ISBN 13 : 9780580489822
Total Pages : 52 pages
Book Rating : 4.4/5 (898 download)
Download or read book Sterilization of Health Care Products. Moist Heat. Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices written by British Standards Institute Staff and published by . This book was released on 2006-09-29 with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical equipment, Sterilization (hygiene), Steam, Verification, Quality control, Quality assurance, Acceptance (approval), Installation, Performance, Maintenance, Personnel, Medical instruments, Sterilizers, Steam sterilizers
Author :
Publisher :
ISBN 13 : 9788325105785
Total Pages : 40 pages
Book Rating : 4.1/5 (57 download)
Download or read book Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1: 2006) written by and published by . This book was released on 2006 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt:
