Description

ASTM F561 – Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids

1.1 This practice covers recommendations for the retrieval, handling, and analysis of implanted medical devices and associated specimens that are removed from human and animal subjects during revision surgery and at postmortem. This practice may be used for the analysis of any implant including inert, bioactive, resorbable, and tissue engineered products. This practice can also be used for analysis of specimens and fluids from in vitro tests, including those from wear tests and joint simulators. The aim is to provide guidance to minimize iatrogenic damage during the recovery and handling of the associated specimens which could obscure the investigational results. This practice is also intended to provide guidance as to gathering data at the proper time and circumstance.