Stérilisation des produits de santé : exigences générales pour la caractérisation d'un agent stérilisant et pour le développement, la validation et la vérification de routine d'un processus de stérilisation pour dispositifs médicaux

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ISBN 13 : 9781553245858
Total Pages : 38 pages
Book Rating : 4.2/5 (458 download)

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Book Synopsis Stérilisation des produits de santé : exigences générales pour la caractérisation d'un agent stérilisant et pour le développement, la validation et la vérification de routine d'un processus de stérilisation pour dispositifs médicaux by : Association canadienne de normalisation

Download or read book Stérilisation des produits de santé : exigences générales pour la caractérisation d'un agent stérilisant et pour le développement, la validation et la vérification de routine d'un processus de stérilisation pour dispositifs médicaux written by Association canadienne de normalisation and published by . This book was released on 2001 with total page 38 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Stérilisation des produits de santé

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ISBN 13 : 9781554364503
Total Pages : pages
Book Rating : 4.3/5 (645 download)

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Book Synopsis Stérilisation des produits de santé by : Association canadienne de normalisation

Download or read book Stérilisation des produits de santé written by Association canadienne de normalisation and published by . This book was released on 2007 with total page 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. Moist Heat. Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices

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ISBN 13 : 9780580489822
Total Pages : 52 pages
Book Rating : 4.4/5 (898 download)

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Book Synopsis Sterilization of Health Care Products. Moist Heat. 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. 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

Sterilization of Health Care Products. Dry Heat. Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices

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ISBN 13 : 9780580779336
Total Pages : 74 pages
Book Rating : 4.7/5 (793 download)

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Book Synopsis Sterilization of Health Care Products. Dry Heat. 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. Dry 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 1913-04-30 with total page 74 pages. Available in PDF, EPUB and Kindle. Book excerpt: Sterilization (hygiene), Sterile equipment, Sterilizers, Medical equipment, Medical instruments, Process control, Quality control, Verification

Développement et validation des procédés de stérilisation par la chaleur humide

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ISBN 13 :
Total Pages : 236 pages
Book Rating : 4.:/5 (1 download)

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Book Synopsis Développement et validation des procédés de stérilisation par la chaleur humide by : Fatima-Zahra Malha

Download or read book Développement et validation des procédés de stérilisation par la chaleur humide written by Fatima-Zahra Malha and published by . This book was released on 2017 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pour assurer la sécurité et la qualité des médicaments destinés à être stériles, la réglementation impose la vérification de la stérilité de ces produits, ainsi que la qualification et la validation de tous les moyens et les procédés utilisés pour leur stérilisation. Le choix du procédé de stérilisation doit être adapté à l'entité à stériliser de sorte à maintenir sa stabilité et son intégrité. Cela nécessite dans certains cas le développement et l'utilisation de différentes méthodes de stérilisation dans le cadre du même procédé de fabrication, ce qui entraîne une certaine complexité et des contraintes à gérer au niveau industriel. Selon les réglementations en vigueur, la stérilisation par la chaleur humide dans un autoclave est à utiliser en première intention, car ce procédé est d'une grande efficacité pour l'inactivation d'un large spectre de microorganismes. Cette thèse s'attache à décrire les notions théoriques nécessaires au développement et à la validation d'un procédé de stérilisation par la chaleur humide. La première partie de cette thèse sera dédiée à la présentation des méthodes de stérilisation les plus utilisées dans l'industrie pharmaceutique, à la description des notions théoriques nécessaires à la compréhension et au développement d'un procédé de stérilisation par la chaleur humide, ainsi qu'aux méthodes et moyens à mettre en œuvre pour évaluer l'efficacité du procédé lors des validations. La deuxième partie a pour objet l'explication du déroulement des grandes étapes de développement et de validation du procédé de stérilisation par la chaleur humide, en mettant en application les notions présentées dans la première partie de la thèse.

Stérilisation des dispositifs médicaux

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Publisher :
ISBN 13 :
Total Pages : 62 pages
Book Rating : 4.:/5 (144 download)

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Book Synopsis Stérilisation des dispositifs médicaux by : Association canadienne de normalisation

Download or read book Stérilisation des dispositifs médicaux written by Association canadienne de normalisation and published by . This book was released on 1998 with total page 62 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Sterilization of Health Care Products

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ISBN 13 :
Total Pages : 51 pages
Book Rating : 4.:/5 (954 download)

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Book Synopsis Sterilization of Health Care Products by : International Organization for Standardization

Download or read book Sterilization of Health Care Products written by International Organization for Standardization and published by . This book was released on 2013 with total page 51 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. 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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Publisher :
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

Stérilisation des dispositifs médicaux

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ISBN 13 :
Total Pages : 61 pages
Book Rating : 4.:/5 (3 download)

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Book Synopsis Stérilisation des dispositifs médicaux by : Association canadienne de normalisation

Download or read book Stérilisation des dispositifs médicaux written by Association canadienne de normalisation and published by . This book was released on 1998 with total page 61 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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

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

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ISBN 13 : 9780580770715
Total Pages : 50 pages
Book Rating : 4.7/5 (77 download)

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Book Synopsis Sterilization of Health Care Products. Radiation. 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. Radiation. 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 2006-08-31 with total page 50 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medical equipment, Sterilization (hygiene), Radiation, Ionizing radiation, Gamma-radiation, Electron beams, X-rays, Radiation measurement, Verification, Quality control, Quality assurance, Medical technology, Process specification, Documents, Records (documents), Calibration, Maintenance, Medical instruments

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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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.

Stérilisation à basse température dans les établissements de santé Français

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ISBN 13 :
Total Pages : 0 pages
Book Rating : 4.:/5 (137 download)

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Book Synopsis Stérilisation à basse température dans les établissements de santé Français by : Thomas Dziura

Download or read book Stérilisation à basse température dans les établissements de santé Français written by Thomas Dziura and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: La Stérilisation à Basse Température (SBT) permet le traitement des Dispositifs Médicaux Réutilisables (DMR) thermosensibles tel que les endoscopes souples, les optiques de robots chirurgicaux, des sondes d'échographie pour cavités stériles, mais aussi des DMR commercialisés plus récemment pour de nouvelles techniques chirurgicales. Tous les hôpitaux ne sont pas équipés pour faire de la SBT et traitent leurs DMR de catégorie critique thermosensibles par une désinfection de haut niveau (DHN). La Société Française d'Hygiène Hospitalière va publier en novembre 2022 une mise à jour du Guide de bonnes pratiques de désinfection des dispositifs médicaux. Cette mise à jour fait la promotion de la SBT au détriment de la désinfection de haut niveau. L'objectif est donc d'inciter à ne plus utiliser de DMR thermosensible ayant subi une désinfection de haut niveau pour un geste médical ou chirurgical nécessitant l'abord une cavité stérile (abdomen, appareil urinaire ... ). Le principal objectif de cette étude était de voir dans quelle mesure les établissements de santé vont appliquer ces nouvelles recommandations, qu'ils soient équipés ou non d'un stérilisateur à basse température. De ce fait un état des lieux de la SBT en France a été proposé. Un questionnaire a été diffusé à l'attention des services de stérilisation Français et 53 réponses ont été recueillies. Les résultats de cette étude permettent d'évaluer comment les établissements de soins envisagent de s'adapter vis-à-vis des nouvelles recommandations. La parution de la norme NF ISO 22441 relative aux exigences pour la mise au point, la validation et le contrôle de routine d'un procédé de stérilisation [au peroxyde d'hydrogène gazeux] pour dispositifs médicaux, montre bien que le procédé se pérennise et se structure.

Rédaction d'un référentiel des dispositifs médicaux restérilisables utilisé pour la formation des personnels de la stérilisation

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ISBN 13 :
Total Pages : 246 pages
Book Rating : 4.:/5 (69 download)

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Book Synopsis Rédaction d'un référentiel des dispositifs médicaux restérilisables utilisé pour la formation des personnels de la stérilisation by : Hiba Najia Naas

Download or read book Rédaction d'un référentiel des dispositifs médicaux restérilisables utilisé pour la formation des personnels de la stérilisation written by Hiba Najia Naas and published by . This book was released on 2009 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: