Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

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ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (139 download)

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Book Synopsis Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices by :

Download or read book Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices written by and published by . This book was released on 2009 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Sterilization of Health Products : General Requirements for Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices

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ISBN 13 : 9781553245872
Total Pages : 36 pages
Book Rating : 4.2/5 (458 download)

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Book Synopsis Sterilization of Health Products : General Requirements for Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices by : Canadian Standards Association

Download or read book Sterilization of Health Products : General Requirements for Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices written by Canadian Standards Association and published by . This book was released on 2001 with total page 36 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Sterilization of Health Care Products. General Requirements for Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices

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ISBN 13 : 9780580370854
Total Pages : 50 pages
Book Rating : 4.3/5 (78 download)

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Book Synopsis Sterilization of Health Care Products. General Requirements for Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices by : British Standards Institute Staff

Download or read book Sterilization of Health Care Products. General Requirements for Characterization of a Sterilizing Agent and 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 2001-03 with total page 50 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sterilization (hygiene), Sterile equipment, Sterilizers, Medical equipment, Medical instruments, Process control, Quality control, Verification

Sterilization of Health Care Products-General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices

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ISBN 13 : 9781570201486
Total Pages : pages
Book Rating : 4.2/5 (14 download)

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Book Synopsis Sterilization of Health Care Products-General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices by : Association for the Advancement of Medical Instrumentation

Download or read book Sterilization of Health Care Products-General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices written by Association for the Advancement of Medical Instrumentation and published by . This book was released on 2001-02 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

UNE-EN ISO 14937:2010

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ISBN 13 :
Total Pages : 52 pages
Book Rating : 4.:/5 (16 download)

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Book Synopsis UNE-EN ISO 14937:2010 by :

Download or read book UNE-EN ISO 14937:2010 written by and published by . This book was released on 2018 with total page 52 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Sterilization of Health Care Products. Liquid Chemical Sterilizing Agents for Single-Use Medical Devices Utilizing Animal Tissues and Their Derivatives. Requirements for Characterization, Development, Validation and Routine Control of a Sterilization Process for Medical Devices

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ISBN 13 : 9780580578519
Total Pages : 46 pages
Book Rating : 4.5/5 (785 download)

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Book Synopsis Sterilization of Health Care Products. Liquid Chemical Sterilizing Agents for Single-Use Medical Devices Utilizing Animal Tissues and Their Derivatives. Requirements for Characterization, Development, Validation and Routine Control of a Sterilization Process for Medical Devices by : British Standards Institute Staff

Download or read book Sterilization of Health Care Products. Liquid Chemical Sterilizing Agents for Single-Use Medical Devices Utilizing Animal Tissues and Their Derivatives. Requirements for Characterization, 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 1911-07-31 with total page 46 pages. Available in PDF, EPUB and Kindle. Book excerpt: Animal products, Sterilization (hygiene), Liquids, Medical equipment, Medical instruments, Sterile equipment, Disposable, Verification, Quality control, Certification (approval), Compatibility, Performance, Personnel, Maintenance, Microbiological analysis, Microorganisms

Sterilization of Health Care Products. Liquid Chemical Sterilizing Agents for Single-use Medical Devices Utilizing Animal Tissues and Their Derivatives. Requirements for Characterization, Development, Validation and Routine Control of a Sterilization Process for Medical Devices

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Publisher :
ISBN 13 :
Total Pages : 54 pages
Book Rating : 4.:/5 (126 download)

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Book Synopsis Sterilization of Health Care Products. Liquid Chemical Sterilizing Agents for Single-use Medical Devices Utilizing Animal Tissues and Their Derivatives. Requirements for Characterization, Development, Validation and Routine Control of a Sterilization Process for Medical Devices by : British Standards Institution

Download or read book Sterilization of Health Care Products. Liquid Chemical Sterilizing Agents for Single-use Medical Devices Utilizing Animal Tissues and Their Derivatives. Requirements for Characterization, Development, Validation and Routine Control of a Sterilization Process for Medical Devices written by British Standards Institution and published by . This book was released on 2021 with total page 54 pages. Available in PDF, EPUB and Kindle. Book excerpt:

UNE-EN ISO 14160:2012

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Publisher :
ISBN 13 :
Total Pages : 45 pages
Book Rating : 4.:/5 (16 download)

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Book Synopsis UNE-EN ISO 14160:2012 by :

Download or read book UNE-EN ISO 14160:2012 written by and published by . This book was released on 2018 with total page 45 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Sterilization of Health-Care Products. Ethylene Oxide. Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices

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ISBN 13 : 9780580749124
Total Pages : 94 pages
Book Rating : 4.7/5 (491 download)

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Book Synopsis Sterilization of Health-Care Products. Ethylene Oxide. Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices by : British Standards Institute Staff

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

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)

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Publisher :
ISBN 13 : 9788325105785
Total Pages : 40 pages
Book Rating : 4.1/5 (57 download)

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Book Synopsis 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) by :

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:

Sterilization Validation and Routine Operation Handbook (2001)

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Publisher : CRC Press
ISBN 13 : 1351357565
Total Pages : 155 pages
Book Rating : 4.3/5 (513 download)

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Book Synopsis Sterilization Validation and Routine Operation Handbook (2001) by : Anne F Booth

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 155 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.

Sterilization of Health Care Products. Ethylene Oxide. Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices

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ISBN 13 : 9780580508806
Total Pages : 54 pages
Book Rating : 4.5/5 (88 download)

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Book Synopsis Sterilization of Health Care Products. Ethylene Oxide. Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices by : British Standards Institute Staff

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

Sterilisation of Biomaterials and Medical Devices

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Publisher : Elsevier
ISBN 13 : 0857096265
Total Pages : 347 pages
Book Rating : 4.8/5 (57 download)

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Book Synopsis Sterilisation of Biomaterials and Medical Devices by : Sophie Lerouge

Download or read book Sterilisation of Biomaterials and Medical Devices written by Sophie Lerouge and published by Elsevier. This book was released on 2012-09-27 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: The effective sterilisation of any material or device to be implanted in or used in close contact with the human body is essential for the elimination of harmful agents such as bacteria. Sterilisation of biomaterials and medical devices reviews established and commonly used technologies alongside new and emerging processes.Following an introduction to the key concepts and challenges involved in sterilisation, the sterilisation of biomaterials and medical devices using steam and dry heat, ionising radiation and ethylene oxide is reviewed. A range of non-traditional sterilisation techniques, such as hydrogen peroxide gas plasma, ozone and steam formaldehyde, is then discussed together with research in sterilisation and decontamination of surfaces by plasma discharges. Sterilisation techniques for polymers, drug-device products and tissue allografts are then reviewed, together with antimicrobial coatings for ‘self-sterilisation’ and the challenge presented by prions and endotoxins in the sterilisation of reusable medical devices. The book concludes with a discussion of future trends in the sterilisation of biomaterials and medical devices.With its distinguished editors and expert team of international contributors, Sterilisation of biomaterials and medical devices is an essential reference for all materials scientists, engineers and researchers within the medical devices industry. It also provides a thorough overview for academics and clinicians working in this area. Reviews established and commonly used technologies alongside new and emerging processes Introduces and reviews the key concepts and challenges involved in sterilisation Discusses future trends in the sterilisation of biomaterials and medical devices

Antisepsis, Disinfection, and Sterilization

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Publisher : John Wiley & Sons
ISBN 13 : 1555819680
Total Pages : 431 pages
Book Rating : 4.5/5 (558 download)

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Book Synopsis Antisepsis, Disinfection, and Sterilization by : Gerald E. McDonnell

Download or read book Antisepsis, Disinfection, and Sterilization written by Gerald E. McDonnell and published by John Wiley & Sons. This book was released on 2020-07-10 with total page 431 pages. Available in PDF, EPUB and Kindle. Book excerpt: Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance, by Gerald E. McDonnell, is a detailed and accessible presentation of the current methods of microbial control. Each major category, such as physical disinfection methods, is given a chapter, in which theory, spectrum of activity, advantages, disadvantages, and modes of action of the methods are thoroughly and clearly presented. Sufficient background on the life cycles and general anatomy of microorganisms is provided so that the reader who is new to microbiology will better appreciate how physical and chemical biocides work their magic on microbes. Other topics in the book include: Evaluating the efficacy of chemical antiseptics and disinfectants, and of physical methods of microbial control and sterilization. Understanding how to choose the proper biocidal product and process for specific applications. Classic physical and chemical disinfection methods, such as heat, cold, non-ionizing radiation, acids, oxidizing agents, and metals. Newer chemical disinfectants, including, isothiazolones, micro-and nano-particles, and bacteriophages as control agents. Antisepsis of skin and wounds and the biocides that can be used as antiseptics. Classic methods of physical sterilization, such as, moist heat and dry heat sterilization, ionizing radiation, and filtration, along with newer methods, including, the use of plasma or pulsed light. Chemical sterilization methods that use ethylene oxide, formaldehyde, or a variety of other oxidizing agents. A detailed look at the modes of action of biocides in controlling microbial growth and disrupting microbial physiology. Mechanisms that microorganisms use to resist the effects of biocides. The second edition of Antisepsis, Disinfection, and Sterilization: Types, Action, and Resistance is well suited as a textbook and is outstanding as a reference book for facilities managers and application engineers in manufacturing plants, hospitals, and food production facilities. It is also essential for public health officials, healthcare professionals, and infection control practitioners.

Biomedical Product and Materials Evaluation

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Publisher : Woodhead Publishing
ISBN 13 : 012824173X
Total Pages : 808 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Biomedical Product and Materials Evaluation by : P.V. Mohanan

Download or read book Biomedical Product and Materials Evaluation written by P.V. Mohanan and published by Woodhead Publishing. This book was released on 2022-01-22 with total page 808 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biomedical Product and Materials Evaluation: Standards and Ethics provides a much-needed overview of the procedures, issues, standards and ethical issues in the early development of biomedical products. The book covers a range of key biomedical products, from 3D printed organs and blood derived products, to stem calls and decellularized tissue products. Each chapter reviews a single product type, associated materials, biomedical applications, proven development strategies, and potential challenges. The core focus of the book is on the standardization and ethical aspects of biomedical product development, with these elements addressed and discussed in chapters dedicated to product evaluation. This is a useful reference for academics, researchers and industry professionals in R&D groups with an interest in biomaterial research and production, as well as those working in the fields of biomedical engineering, biotechnology and toxicology. Covers a variety of biomedical products, including specific biomaterials, organs-on-chips, wound care products, combinational products, and more Delves into strategies and considerations for product evaluation, including cytotoxicity assays, microbial and blood compatibility studies Discusses standardization and ethical hurdles in biomedical product development and how to overcome them

WHO Expert Committee on Specifications for Pharmaceutical Preparations

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Publisher : World Health Organization
ISBN 13 : 924006382X
Total Pages : 430 pages
Book Rating : 4.2/5 (4 download)

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Book Synopsis WHO Expert Committee on Specifications for Pharmaceutical Preparations by : World Health Organization

Download or read book WHO Expert Committee on Specifications for Pharmaceutical Preparations written by World Health Organization and published by World Health Organization. This book was released on 2022-12-22 with total page 430 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition

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Publisher : CRC Press
ISBN 13 : 1420021621
Total Pages : 500 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition by : Stephen P. Denyer

Download or read book Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition written by Stephen P. Denyer and published by CRC Press. This book was released on 2006-12-26 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: Microbiological matters continue to exercise considerable influence on product quality. In both the pharmaceutical and medical device industries, products of greater sophistication, along with evolving regulatory requirements, are elevating the challenges related to maintaining microbiological integrity. Updated to reflect technological and regulatory changes, the Guide to Microbiological Control in Pharmaceuticals and Medical Devices, Second Edition covers thoseprincipal aspects of microbiology that arerelevant to the preformulation, formulation, manufacturing, and license application stages involved with the production of pharmaceuticals and medical devices. In recognition of the diverse disciplines involved in pharmaceutical and medical device production, this work provides a brief introduction to microbiology geared towards the nonmicrobiologist. Covering good manufacturing practice in the control of contamination, the text explores quality control, the preservation of formulations, and principles of sterilization, including microbiological-specific considerations for biotechnological products and other medical devices. It also provides additional materials on package integrity and contamination risks in clean rooms. The editors have produced a companion text, the Handbook of Microbiological Quality Control in Pharmaceuticals and Medical Devices (see reverse), which when paired with the Guide offers a complete theoretical and practical treatment of microbiological control. This book provides a comprehensive distillation of information concerning methodology and regulations that would otherwise remain scattered throughout the literature. It allows scientists from many fields to address potential problems in advance and implement suitable strategies at the earliest stages of development.