ASTM F 1635 : 2016 : REDLINE
Current
The latest, up-to-date edition.
Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
English
01-12-2016
Important note : All end users must be registered with an Account prior to user licenses being assigned.CONTAINED IN VOL. 13.01, 2017 Describes in vitro degradation of hydrolytically degradable polymers (HDP) intended for use in surgical implants.
| Committee |
F 04
|
| DocumentType |
Redline
|
| Pages |
8
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Current
|
1.1This test method covers in vitro degradation of hydrolytically degradable polymers (HDP) intended for use in surgical implants.
1.2The requirements of this test method apply to HDPs in various forms:
1.2.1Virgin polymer resins, or
1.2.2Any form fabricated from virgin polymer such as a semi-finished component of a finished product, a finished product, which may include packaged and sterilized implants, or a specially fabricated test specimen.
1.3This test method provides guidance for mechanical loading or fluid flow, or both, when relevant to the device being evaluated. The specifics of loading type, magnitude, and frequency for a given application are beyond the scope of this test method.
1.4The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5This 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.
| ASTM F 3225 : 2017 | Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs) |
| PD ISO/TS 17137:2014 | Cardiovascular implants and extracorporeal systems. Cardiovascular absorbable implants |
| BS ISO 13781:2017 | Implants for surgery. Homopolymers, copolymers and blends on poly(lactide). In vitro degradation testing |
| ISO/TS 17137:2014 | Cardiovascular implants and extracorporeal systems Cardiovascular absorbable implants |
| AAMI ISO TIR 17137 : 2014 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOVASCULAR ABSORBABLE IMPLANTS |
| ASTM F 2027 : 2016 : REDLINE | Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
| ASTM F 2150 : 2013 : REDLINE | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products |
| ASTM F 2502 : 2017 : REDLINE | Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants |
| ASTM F 2224 : 2009 : R2014 | Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants |
| ASTM F 3036 : 2013 | Standard Guide for Testing Absorbable Stents |
| ISO 13781:2017 | Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing |
| ASTM F 2903 : 2011 | Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020) |
| ASTM F 2883 : 2011 | Standard Guide for Characterization of Ceramic and Mineral Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications (Withdrawn 2020) |
| 15/30296854 DC : 0 | BS ISO 13781 - INPLANTS FOR SURGERY - HOMOPOLYMERS, COPOLYMERS AND BLENDS ON POLY(LACTIDE) - IN VITRO DEGRADATION TESTING |
| ASTM F 3223 : 2017 | Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction |
| ASTM F 3260 : 2018 : REDLINE | Standard Test Method for Determining the Flexural Stiffness of Medical Textiles |
| ASTM F 2224 : 2009 | Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants |
| ASTM D 2857 : 2016 | Standard Practice for Dilute Solution Viscosity of Polymers |
| ASTM D 671 : 1993 | Standard Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force (Withdrawn 2002) |
| ISO 13781:2017 | Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing |
| ASTM D 790 : 2017 : REDLINE | Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials |
| ASTM F 748 : 2016 : REDLINE | Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 10993-9:2009 | Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
| ASTM D 695 : 2015 : REDLINE | Standard Test Method for Compressive Properties of Rigid Plastics |
| ASTM D 1822 : 2013 : REDLINE | Standard Test Method for Tensile-Impact Energy to Break Plastics and Electrical Insulating Materials |
| ASTM D 638 : 2014 : REDLINE | Standard Test Method for Tensile Properties of Plastics |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.