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Medical device guidelines and regula...

Shanmugam, Prakash Srinivasan Timiri.

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Medical device guidelines and regulations handbook

Record Type:	Electronic resources : Monograph/item
Title/Author:	Medical device guidelines and regulations handbook/ edited by Prakash Srinivasan Timiri Shanmugam ... [et al.].
other author:	Shanmugam, Prakash Srinivasan Timiri.
Published:	Cham :Springer International Publishing : : 2022.,
Description:	vi, 385 p. :ill. (some col.), digital ;24 cm.
[NT 15003449]:	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
Subject:	Medical instruments and apparatus. -
Online resource:	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

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520 $a 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.
650 0 $a Medical instruments and apparatus. $3 672534
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650 1 4 $a Biomedical Engineering and Bioengineering. $3 3381533
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650 2 4 $a Medical and Health Technologies. $3 3595637
700 1 $a Shanmugam, Prakash Srinivasan Timiri. $3 3510132
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