Includes bibliographical references and index.

ISO 14155: Clinical Investigation of Medical Devices for Human Subjects -- ISO 13485: Medical Devices – Quality Management Systems, Requirements for Regulatory Purposes -- ISO 14971 and ISO 24971: Medical Device Risk Management -- ISO 19227: Implants for Surgery – Cleanliness of Orthopedic Implants -- ISO 21534: Non-active Surgical Implants – Joint Replacement Implants -- ISO 16061: Instrumentation for Use in Association with Non-active Surgical Implants—General Requirements -- ISO 22442: Medical Devices Utilizing Animal Tissues and Their Derivatives -- ISO 11137: An Overview on Radiation for Sterilization of Medical Devices and Healthcare Products -- ISO 11135: Sterilization of Health-Care Products—Ethylene Oxide, Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices -- An Overview on Sterilization of Health Care Products using Moist Heat: ISO 17665 -- ISO 10993: Biological Evaluation of Medical Devices -- FDA-CFR Title 21-Food and Drugs: Parts 800 to 1299 -- EU 1907/2006 – Registration, Evaluation, Authorisation and Restriction of Chemicals -- EU 1272/2008 – Classification, Labelling and Packaging of Substances and Mixtures --
EU 2015/863: Restriction of Hazardous Substances (RoHS) -3 -- EU 722/2012 – Animal Tissue Regulations in Effect for Some Medical Devices -- EU 2017/746 – In Vitro Diagnostic Medical Devices -- Device Regulations of Other Countries