Full Description
This comprehensive resource features in-depth discussions of important guidelines and regulations needed 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.
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.
