1.1 The purpose of this standard practice is to describe how the limit values for single use implants as manufactured shall be set. 1.2 The standard practice does not address limit values for substances which are intrinsic to the implant properties or design. In particular it does not address substances released during implant resorption, implant coatings, or leachables by design. 1.3 This standard practice does not address limit values for implants which are re-processed, re-cleaned after unpacking for re-use in the hospital or by the manufacturer. 1.4 This standard practice is intended solely to provide guidance regarding suitable assessment methods and defining limit values for residues, which may or may not affect implant biocompatibility. This standard does not address biocompatibility as an intrinsic material property. Biocompatibliy is addressed in F748 Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices, or in ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation and testing. 1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Currently, there are no guidlines or practices that help medical device industries to set limit values for residues in quality control.
Keywordscleanliness, residues, limit value, toxicology, medical device
The title and scope are in draft form and are under development within this ASTM Committee.Back to Top
Draft Under Development