TY  - BOOK
AU  - Timiri Shanmugam,Prakash Srinivasan
AU  - Thangaraju,Pugazhenthan
AU  - Palani,Nandakumar
AU  - Sampath,Thamizharasan
ED  - SpringerLink (Online service)
TI  - Medical Device Guidelines and Regulations Handbook
SN  - 9783030918552
PY  - 2022///
CY  - Cham
PB  - Springer International Publishing, Imprint: Springer
KW  - Biomedical engineering
KW  - Biomedical Engineering and Bioengineering
KW  - Biomedical Devices and Instrumentation
KW  - Medical and Health Technologies
KW  - Equipment and Supplies -- standards
KW  - Equipment Design -- standards
KW  - Materials Testing -- standards
N1  - 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
N2  - 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
UR  - https://doi.org/10.1007/978-3-030-91855-2
ER  -