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Medical device guidelines and regula...
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Shanmugam, Prakash Srinivasan Timiri.
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Medical device guidelines and regulations handbook
紀錄類型:
書目-電子資源 : Monograph/item
正題名/作者:
Medical device guidelines and regulations handbook/ edited by Prakash Srinivasan Timiri Shanmugam ... [et al.].
其他作者:
Shanmugam, Prakash Srinivasan Timiri.
出版者:
Cham :Springer International Publishing : : 2022.,
面頁冊數:
vi, 385 p. :ill. (some col.), digital ;24 cm.
內容註:
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.
Contained By:
Springer Nature eBook
標題:
Medical instruments and apparatus. -
電子資源:
https://doi.org/10.1007/978-3-030-91855-2
ISBN:
9783030918552
Medical device guidelines and regulations handbook
Medical device guidelines and regulations handbook
[electronic resource] /edited by Prakash Srinivasan Timiri Shanmugam ... [et al.]. - Cham :Springer International Publishing :2022. - vi, 385 p. :ill. (some col.), digital ;24 cm.
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.
ISBN: 9783030918552
Standard No.: 10.1007/978-3-030-91855-2doiSubjects--Topical Terms:
672534
Medical instruments and apparatus.
LC Class. No.: R856 / .M43 2022
Dewey Class. No.: 610.284
Medical device guidelines and regulations handbook
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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.
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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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