ASTMF561–97;RJU2MS05NW__.pdfVIP

NOTICE: This standard has either been superceded and replaced by a new version or discontinued. Contact ASTM International () for the latest information. Designation: F 561 – 97 Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated Tissues1 This standard is issued under the fixed designation F 561; the number immediately following the designation indicates the year of original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A superscript epsilon () indicates an editorial change since the last revision or reapproval. 1. Scope appropriate means that does not adversely affect the implant or 1.1 This practice covers recommendations for the retrieval, the associated tissue that may be subject to subsequent handling, and analysis of implantable medical devices and analysis. This standard does not purport to address all of the associated specimens which are removed from patients, during safety concerns, if any, associated with its use. It is the revision surgery, at postmortem, or as part of animal studies. responsibility of the user of this standard to establish appro- The aim is to provide guidance in preventing damage to the priate safety and health practices and determine the applica- associated specimens which could obscure the investigational bility of regulatory limitations prior to use. results, and in gathering data at the proper time and circum- 2. Referenced Documents stance to validate the study. 1.2 This practice offers guidelines for