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ASTM F1635-04a

(Test Method)

Standard Test Method for in Vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants

Standard Test Method for <i>in Vitro</i> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants

SCOPE
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.

General Information

Status
Historical
Publication Date
30-Sep-2004
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.15 - Material Test Methods
Current Stage
Ref Project

Relations

Replaces
ASTM F1635-04 - Standard Test Method for <i>in Vitro</i> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
Effective Date
01-Oct-2004
Replaced By
ASTM F1635-11 - Standard Test Method for <i>in vitro</i> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
Effective Date
01-Mar-2011
Referred By
ASTM F2502-17 - Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
Effective Date
01-Oct-2004
Referred By
ASTM F3510-21 - Standard Guide for Characterizing Fiber-Based Constructs for Tissue-Engineered Medical Products
Effective Date
01-Oct-2004
Referred By
ASTM F3225-17(2022) - Standard Guide for Characterization and Assessment of Vascular Graft Tissue Engineered Medical Products (TEMPs)
Effective Date
01-Oct-2004
Referred By
ASTM F561-19 - Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
Effective Date
01-Oct-2004
Referred By
ASTM F2224-09(2020) - Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
Effective Date
01-Oct-2004
Referred By
ASTM F3260-18 - Standard Test Method for Determining the Flexural Stiffness of Medical Textiles
Effective Date
01-Oct-2004
Referred By
ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
Effective Date
01-Oct-2004
Referred By
ASTM F2150-19 - Standard Guide for Characterization and Testing of Biomaterial Scaffolds Used in Regenerative Medicine and Tissue-Engineered Medical Products
Effective Date
01-Oct-2004
Referred By
ASTM F3223-17 - Standard Guide for Characterization and Assessment of Tissue Engineered Medical Products (TEMPs) for Knee Meniscus Surgical Repair and/or Reconstruction
Effective Date
01-Oct-2004
Referred By
ASTM F3036-21 - Standard Guide for Testing Absorbable Stents
Effective Date
01-Oct-2004
Referred By
ASTM F3274-21 - Standard Guide for Testing and Characterization of Alginate Foam Scaffolds Used in Tissue-Engineered Medical Products (TEMPs)
Effective Date
01-Oct-2004
Referred By
ASTM F1983-23 - Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
Effective Date
01-Oct-2004

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ASTM F1635-04a - Standard Test Method for <i>in Vitro</i> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical ImplantsASTM F1635-04a - Standard Test Method for <i>in Vitro</i> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
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ASTM F1635-04a - Standard Test Method for <i>in Vitro</i> Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants
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Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F1635–04a
Standard Test Method for
in vitro Degradation Testing of Hydrolytically Degradable
Polymer Resins and Fabricated Forms for Surgical
1
Implants
This standard is issued under the fixed designation F1635; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope D790 Test Methods for Flexural Properties of Unreinforced
and Reinforced Plastics and Electrical Insulating Materials
1.1 This test method covers in vitro degradation of hydro-
D882 Test Method for Tensile Properties of Thin Plastic
lytically degradable polymers (HDP) intended for use in
Sheeting
surgical implants.
D1708 Test Method for Tensile Properties of Plastics by
1.2 The requirements of this test method apply to HDPs in
Use of Microtensile Specimens
various forms:
D1822 Test Method for Tensile-Impact Energy to Break
1.2.1 Virgin polymer resins, or
Plastics and Electrical Insulating Materials
1.2.2 Any form fabricated from virgin polymer such as a
D2857 Practice for Dilute Solution Viscosity of Polymers
semi-finished component of a finished product, a finished
F748 Practice for Selecting Generic Biological Test Meth-
product, which may include packaged and sterilized implants,
ods for Materials and Devices
or a specially fabricated test specimen.
2.2 Other Referenced Standard:
1.3 This test method has no provisions for mechanical
ISO 10993-9:1999 Biological Evaluation of Medical
loading, fluid flow, or other dynamic challenges.
Devices—Part 9 Framework for Identification and Quan-
1.4 This standard does not purport to address all of the
4
tification of Potential Degradation Products
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
3. Terminology
priate safety and health practices and determine the applica-
3.1 Definitions:
bility of regulatory limitations prior to use.
3.1.1 resin—any polymer that is a basic material for plas-
5
2. Referenced Documents tics.
2
3.1.2 hydrolytically degradable polymer (HDP)—any poly-
2.1 ASTM Standards:
meric material in which the primary mechanism of chemical
D638 Test Method for Tensile Properties of Plastics
degradation in the body is by hydrolysis (water reacting with
D671 Test Method for Flexural Fatigue of Plastics by
3 the polymer resulting in cleavage of the chain).
Constant-Amplitude-of-Force
D695 Test Method for Compressive Properties of Rigid
4. Summary of Test Method
Plastics
4.1 Samples of polymer resins, semi-finished components,
D747 Test Method for Apparent Bending Modulus of Plas-
finishedsurgicalimplants,orspeciallydesignedtestspecimens
tics by Means of a Cantilever Beam
fabricated from those resins are placed in buffered saline
solution at physiologic temperatures. Samples are periodically
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
removed and tested for various material or mechanical prop-
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
erties at specified intervals. The required test intervals vary
F04.15 on Material Test Methods.
greatly depending on the specific polymeric composition. For
Current edition approved Oct. 1, 2004. Published October 2004. Originally
approved in 1995. Last previous edition approved in 2004 as F1635 – 04. DOI: example,poly(l-lactide)andpoly(e-caprolactone)degradevery
10.1520/F1635-04A.
slowly and can require two or more years for complete
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
4
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036.
3 5
Withdrawn. Polymer Technology Dictionary, Tony Whelan ed., Chapman & Hall, 1994.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F1635–04a
degradation. Polymers based substantially on glycolide can range (see X1.3.1). The ionic concentration should be in the
completely degrade in two to three months depending on the physiological range for the intended application (for example,
exact composition and on the size of the specimen. Degrada- asolutionthatcontains0.1Mphosphatebufferand0.1MNaCl
tion time is also strongly affected by specimen size, polymer would be appropriate for most tissue or blood contact devices).
molecular weight, and crystallinity. The solution-to-HDP mass ratio shall be as hig
...

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1.7 This document is a guide. As defined by ASTM in their “Form and Style for ASTM Standards” book in section C15.2, “A standard guide is a compendium of information or series of options that does not recommend a specific course of action. Guides are intended ...

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Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

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5.1 The current hip simulator wear test standards (ISO 14242-1 or ISO 14242-3) stipulate only one load waveform and one set of articulation motions. There is a need for more versatile and rigorous wear test regimes, but the knowledge of what represents realistic high demand wear test features is limited. More research is clearly needed before a standard that defines what a representative high demand wear test should include can be written. The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations.  
5.2 This guide makes suggestions of what high demand test features may need to be added to an overall high demand wear test regime. The features described here are not meant to be all inclusive. Based on current knowledge they appear to be relevant to adverse conditions that can occur in clinical use.  
5.3 All the test features, both conventional and high demand, could have interactive effects on the wear of the components.
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1.1 The objective of this guide is to advise researchers on the possible high demand wear test features that should be included in evaluation of hard-on-hard articulations. This guide makes suggestions for high demand test features that may need to be added to an overall wear test regime. Device articulating components manufactured from other metallic alloys, ceramics, or with coated or elementally modified surfaces without significant clinical use could possibly be evaluated with this guide. However, such materials may include risks and failure mechanisms that are not addressed in this guide.  
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Standard Specification and Test Methods for Metallic Medical Bone Screws

ABSTRACT
This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. There are a large variety of medical bone screws currently in use, the following type of screws are used: type HA - spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head, type HB - spherical undersurface of head, deep, asymmetrical buttress thread, and shallow screw head, type HC - conical undersurface of head, symmetrical thread, and type HD - conical undersurface of head, symmetrical thread. The torsional strength, breaking angle, axial pullout strength, insertion torque, self-tapping force, and removal torque shall be tested to meet the requirements prescribed.
SIGNIFICANCE AND USE
A1.1 Significance and Use
A1.1.1 This test method is used to measure the torsional yield strength, maximum torque, and breaking angle of the bone screw under standard conditions. The results obtained in this test method are not intended to predict the torque encountered while inserting or removing a bone screw in human or animal bone. This test method is intended only to measure the uniformity of the product tested or to compare the mechanical properties of different, yet similarly sized, products.
SCOPE
1.1 This specification provides requirements for materials, finish and marking, care and handling, and the acceptable dimensions and tolerances for metallic bone screws that are implanted into bone. The dimensions and tolerances in this specification are applicable only to metallic bone screws described in this specification.  
1.2 This specification provides performance considerations and standard test methods for measuring mechanical properties in torsion of metallic bone screws that are implanted into bone. These test methods may also be applicable to other screws besides those whose dimensions and tolerances are specified here. The following annexes are included:  
1.2.1 Annex A1—Test Method for Determining the Torsional Properties of Metallic Bone Screws.  
1.2.2 Annex A2—Test Method for Driving Torque of Medical Bone Screws.  
1.2.3 Annex A3—Test Method for Determining the Axial Pullout Load of Medical Bone Screws.  
1.2.4 Annex A4—Test Method for Determining the Self-Tapping Performance of Self-Tapping Medical Bone Screws.  
1.2.5 Annex A5—Specifications for Type HA and Type HB Metallic Bone Screws.  
1.2.6 Annex A6—Specifications for Type HC and Type HD Metallic Bone Screws.  
1.2.7 Annex A7—Specifications for Metallic Bone Screw Drive Connections.  
1.3 This specification is based, in part, upon ISO 5835, ISO 6475, and ISO 9268.  
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.5 Multiple test methods are included in this standard. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may only be a subset of the herein described test methods.  
1.6 This standard may involve the use of hazardous materials, operations, and equipment. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Technical specification
    22 pages
    English language
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  • Technical specification
    22 pages
    English language
    sale 15% off