ASTM F 1635 : 2016
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
Hardcopy , PDF
English
01-12-2016
Important note : Users cannot be edited or removed once added to your Multi user PDF.This test method covers in vitro degradation of hydrolytically degradable polymers (HDP) intended for use in surgical implants.
| Committee |
F 04
|
| DocumentType |
Test Method
|
| Pages |
7
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Current
|
| Supersedes |
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 3260 : 2018 | Standard Test Method for Determining the Flexural Stiffness of Medical Textiles |
| ASTM F 561 : 2019 | Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids |
| 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Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications (Withdrawn 2020) |
| ASTM F 2027 : 2016 | Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
| ASTM F 2502 : 2017 | Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants |
| ASTM F 2150 : 2013 | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products |
| ASTM F 3225 : 2017 | Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs) |
| 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 3036 : 2013 | Standard Guide for Testing Absorbable Stents |
| ASTM F 2224 : 2009 : R2014 | Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants |
| ASTM F 2903 : 2011 | Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020) |
| ASTM D 2857 : 2016 | Standard Practice for Dilute Solution Viscosity of Polymers |
| ASTM D 1708 : 1996 | Standard Test Method for Tensile Properties of Plastics By Use of Microtensile Specimens |
| ASTM D 1708 : 2006 : REV A | Standard Test Method for Tensile Properties of Plastics by Use of Microtensile Specimens |
| ASTM D 2857 : 1995 : R2001 | Standard Practice for Dilute Solution Viscosity of Polymers |
| ASTM D 2857 : 1995 | Standard Practice for Dilute Solution Viscosity of Polymers |
| ASTM D 1708 : 2002 | Standard Test Method for Tensile Properties of Plastics By Use of Microtensile Specimens |
| ASTM D 1708 : 2006 | Standard Test Method for Tensile Properties of Plastics by Use of Microtensile Specimens |
| ASTM D 2857 : 1995 : R2007 | Standard Practice for Dilute Solution Viscosity of Polymers (Withdrawn 2016) |
| ASTM D 2857 : 1970 : R1977 | Standard Test Method for Dilute Solution Viscosity Of Polymers |
| ASTM D 2857 : 2022 | Standard Practice for Dilute Solution Viscosity of Polymers |
| ASTM D 1822 : 2013 | Standard Test Method for Tensile-Impact Energy to Break Plastics and Electrical Insulating Materials |
| ASTM D 1822 : 2006 | Standard Test Method for Tensile-Impact Energy to Break Plastics and Electrical Insulating Materials |
| ASTM D 638 : 2014 | Standard Test Method for Tensile Properties of Plastics |
| ASTM D 1822 : 1999 | Standard Test Method for Tensile-Impact Energy to Break Plastics and Electrical Insulating Materials |
| ASTM D 1822 : 2021 | Standard Test Method for Determining the Tensile-Impact Resistance of Plastics |
| ASTM D 1708 : 2013 | Standard Test Method for Tensile Properties of Plastics by Use of Microtensile Specimens |
| ASTM D 1708 : 2010 | Standard Test Method for Tensile Properties of Plastics by Use of Microtensile Specimens |
| ASTM D 695 : 2015 | Standard Test Method for Compressive Properties of Rigid Plastics |
| ASTM D 1708 : 2002 : REV A | Standard Test Method for Tensile Properties of Plastics By Use of Microtensile Specimens |
| ASTM D 695 : 2023 | Standard Test Method for Compressive Properties of Rigid Plastics |
| ASTM D 1708 : 2018 | Standard Test Method for Tensile Properties of Plastics by Use of Microtensile Specimens |
| ASTM D 638 : 2022 | 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.