Medical device guidelines and regulations handbook

Medical device guidelines and regulations handbook / Prakash Srinivasan Timiri Shanmugam, Pugazhenthan Thangaraju, Nandakumar Palani, Thamizharasan Sampath, editors.

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...

Full description

Saved in:
Bibliographic Details
Other Authors: Shanmugam, Prakash Srinivasan Timiri (Editor), Thangaraju, Pugazhenthan (Editor), Palani, Nandakumar (Editor), Sampath, Thamizharasan (Editor)
Format: eBook
Language:English
Published: Cham, Switzerland : Springer, 2022.
Subjects:
Medical instruments and apparatus.
Biomedical engineering.
biomedical engineering.
Biomedical engineering
Medical instruments and apparatus
handbooks.
Handbooks and manuals.
Guides et manuels.
Online Access:Click for online access
Table of 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.

Similar Items