ASTM F 1635 : 2004 : REV A
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Standard Test Method for in Vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
Hardcopy , PDF
11-11-2014
English
01-10-2004
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
F 04
|
| DocumentType |
Test Method
|
| Pages |
5
|
| PublisherName |
American Society for Testing and Materials
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
1.1 This test method covers in vitro degradation of hydrolytically degradable polymers (HDP) intended for use in surgical implants.
1.2 The requirements of this test method apply to HDPs in various forms:
1.2.1 Virgin polymer resins, or
1.2.2 Any 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.
1.3 This test method has no provisions for mechanical loading, fluid flow, or other dynamic challenges.
1.4 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.
| ASTM F 3036 : 2013 | Standard Guide for Testing Absorbable Stents |
| ASTM F 2150 : 2013 | Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Tissue-Engineered Medical Products |
| 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Based Scaffolds used for Tissue-Engineered Medical Products (TEMPs) and as Device for Surgical Implant Applications (Withdrawn 2020) |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 2224 : 2009 : R2014 | Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants |
| ASTM F 561 : 2019 | Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids |
| ASTM F 2903 : 2011 | Standard Guide for Tissue Engineered Medical Products (TEMPs) for Reinforcement of Tendon and Ligament Surgical Repair (Withdrawn 2020) |
| 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 | Standard Test Method for Determining the Flexural Stiffness of Medical Textiles |
| ASTM F 3225 : 2017 | Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs) |
| 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 |
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.