ASTM F2502 : 05

Standard Specification and Test Methods for Bioabsorbable Plates and Screws for Internal Fixation Implants

Standard Details

1.1 This specification and test methods covers a mechanical characterization reference for hydrolytically degradable polymer resin (from this point on referenced as "bioabsorbable") plates and screws for orthopedic internal fixation.

1.2 This specification establishes common terminology to describe the size and other physical characteristics of bioabsorbable implants and performance definitions related to the performance of bioabsorbable devices.

1.3 This specification establishes standard test methods to consistently measure performance-related mechanical characteristics of bioabsorbable devices when tested under defined conditions of pretreatment, temperature, humidity, and testing machine speed.

1.4 This specification may not be appropriate for all bioabsorbable devices. The user is cautioned to consider the appropriateness of the standard in view of the particular bioabsorbable device and its potential application.

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.

General Information

Status : Historical

Standard Type: Main

Document No: ASTM F2502 : 05

Document Year: 2005

Pages: 11

Section Volume:
13.02 Volume 13.02 Medical and Surgical Materials and Devices (II): F2502-Latest; Emergency Medical Services; Search and Rescue; Anesthetic and Respiratory Equipment