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Medical Device Guidelines and Regulations Handbook / edited by Prakash Srinivasan Timiri Shanmugam, Pugazhenthan Thangaraju, Nandakumar Palani, Thamizharasan Sampath

Contributor(s): Timiri Shanmugam, Prakash Srinivasan, editor literario | Thangaraju, Pugazhenthan, editor literario | Palani, Nandakumar, editor literario | Sampath, Thamizharasan, editor literario
Material type: materialTypeLabelE-bookPublisher: Cham : Springer International Publishing, 2022Edition: 1st edition 2022.Description: 1 recurso en línea (VI, 385 páginas) : 14 ilustraciones, 12 ilustraciones a color.ISBN: 9783030918552.Subject: Ingeniería biomédica | Medicina -- Material y equipo | Materiales biomédicosOnline resources: Acceso a este recurso digital (usuarios Universidad Europea de Madrid)Digital Resources
Contents:
Guidelines -- ISO 10993 - Biological Evaluation of Medical Devices -- ISO 22442 - Medical Devices utilizing Animal Tissues and Their Derivatives -- ISO 14971 & 24971 - Medical Device Risk Management -- ISO 21534 - Non-Active Surgical Implants - Joint replacement implants -- ISO 16061 Instrumentation for Use in Association with Non-Active Surgical Implants -- ISO 13485 - Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes -- ISO 19227- Implants for Surgery - Cleanliness of Orthopedic implants -- ISO 14155 - Clinical Investigation of Medical Devices for Human Subjects -- ISO 11607 - Packaging for Terminally Sterilized Medical Devices -- ISO 11137 -1, 2 and 3 - Sterilization of Health Care Products -- ISO 11135 - Sterilization of Health Care Products -Ethylene Oxide - Requirements for development, validation and routine control of a sterilization process for medical devices -- ISO 17665-1 - Sterilization of Health Care Products - Moist Heat -- Regulations -- FDA- CFR Title 21 - Food and Drugs: Parts 800 to 1299 -- Global Medical Device Regulations (covering various individual countries) -- EU 722/2012 - Animal Tissue Regulations in Effect for Some Medical Devices -- EU 2017/746 - In Vitro Diagnostic Medical Devices -- EU 1097/2006 - REACH.
Summary: This comprehensive resource features in-depth discussions of important guidelines and regulations you will need to understand and properly meet medical device code-related requirements. Focusing on the practical application of the regulations, the Medical Device Guidelines and Regulations Handbook delivers clear explanations, real-world examples, and annotation on the applicable provisions that will allow you to safely and confidently choose materials and processes for medical device development, testing, and manufacturing. A critical resource for researchers and professionals in the medical device field; Thoroughly covers ISO 10993, ISO 22442, ISO 14971, ISO 13485, ISO 21534, REACH, RoHS, CLP, EU MDR; Presents simplified guidelines and regulation points.
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Holdings
Item type Current library Collection Call number Status Date due Barcode Item holds
LIBRO-E NO PRÉSTAMO LIBRO-E NO PRÉSTAMO Madrid Digital Acceso Electrónico (UEM) Ciencias de la Salud R856 2022 EB (Browse shelf(Opens below)) Acceso electrónico eBook.28102336
Total holds: 0

Guidelines -- ISO 10993 - Biological Evaluation of Medical Devices -- ISO 22442 - Medical Devices utilizing Animal Tissues and Their Derivatives -- ISO 14971 & 24971 - Medical Device Risk Management -- ISO 21534 - Non-Active Surgical Implants - Joint replacement implants -- ISO 16061 Instrumentation for Use in Association with Non-Active Surgical Implants -- ISO 13485 - Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes -- ISO 19227- Implants for Surgery - Cleanliness of Orthopedic implants -- ISO 14155 - Clinical Investigation of Medical Devices for Human Subjects -- ISO 11607 - Packaging for Terminally Sterilized Medical Devices -- ISO 11137 -1, 2 and 3 - Sterilization of Health Care Products -- ISO 11135 - Sterilization of Health Care Products -Ethylene Oxide - Requirements for development, validation and routine control of a sterilization process for medical devices -- ISO 17665-1 - Sterilization of Health Care Products - Moist Heat -- Regulations -- FDA- CFR Title 21 - Food and Drugs: Parts 800 to 1299 -- Global Medical Device Regulations (covering various individual countries) -- EU 722/2012 - Animal Tissue Regulations in Effect for Some Medical Devices -- EU 2017/746 - In Vitro Diagnostic Medical Devices -- EU 1097/2006 - REACH.

This comprehensive resource features in-depth discussions of important guidelines and regulations you will need to understand and properly meet medical device code-related requirements. Focusing on the practical application of the regulations, the Medical Device Guidelines and Regulations Handbook delivers clear explanations, real-world examples, and annotation on the applicable provisions that will allow you to safely and confidently choose materials and processes for medical device development, testing, and manufacturing. A critical resource for researchers and professionals in the medical device field; Thoroughly covers ISO 10993, ISO 22442, ISO 14971, ISO 13485, ISO 21534, REACH, RoHS, CLP, EU MDR; Presents simplified guidelines and regulation points.

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