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Medical Device Guidelines and Regulations Handbook /

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 d...

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Bibliographic Details
Corporate Author: SpringerLink (Online service)
Other Authors: Timiri Shanmugam, Prakash Srinivasan (Editor), Thangaraju, Pugazhenthan (Editor), Palani, Nandakumar (Editor), Sampath, Thamizharasan (Editor)
Format: eBook
Language:English
Published: Cham : Springer International Publishing : Imprint: Springer, 2022.
Edition:1st ed. 2022.
Subjects:
Biomedical engineering.
Biomedical Engineering and Bioengineering.
Biomedical Devices and Instrumentation.
Medical and Health Technologies.
Electronic books.
Online Access:Connect to the full text of this electronic book
Table of Contents:
  • Guidelines
  • ISO 10993 - Biological Evaluation of Medical Devices
  • ISO 22442 - Medical Devices utilizing Animal Tissues and Their Derivatives
  • ISO 14971 and 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.