Medical Implant Standards

https://www.astm.org/products-services/standards-and-publications/standards/medical-device-standards-and-implant-standards.html

ASTM's medical device and implant standards are instrumental in specifying and evaluating the design and performance requirements of a number of biomedical materials, tools, and equipments. These apparatuses are used in surgical procedures …

Implants and Prosthetics | FDA

https://www.fda.gov/medical-devices/products-and-medical-procedures/implants-and-prosthetics

Medical implants are devices or tissues that are placed inside or on the surface of the body. Many implants are prosthetics, intended to replace missing body parts. Other …

Safety of Metals and Other Materials Used in Medical …

https://www.fda.gov/medical-devices/products-and-medical-procedures/safety-metals-and-other-materials-used-medical-devices

Building on prior work and steps outlined in the Medical Device Safety Action Plan announced in 2018, the FDA conducted a comprehensive review of metals used in …

ISO - ISO 13485 — Medical devices

https://www.iso.org/iso-13485-medical-devices.html

Management system standards Providing a model to follow when setting up and operating a management system, find out more about how MSS work and where they can be applied. Highlights from our store ISO 13485:2016 …