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ASTM F2027-00e1

(Guide)

Standard Guide for Characterization and Testing of Substrate Materials for Tissue-Engineered Medical Products

Standard Guide for Characterization and Testing of Substrate Materials for Tissue-Engineered Medical Products

SCOPE
1.1 This guide addresses material characteristics of raw or virgin materials in a non-fabricated form that will ultimately undergo additional processing into growth, support, or delivery vehicles for cells or biomolecules. This guide does not apply to packaged, sterilized, and finished tissue-engineered medical products.
1.2 The purpose of the guide is to assist the developer of tissue-engineered medical products to locate relevant existing standards and test methods and to provide guidance for interim use of materials for which a standard does not exist.

General Information

Status
Historical
Publication Date
09-May-2000
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.42 - Biomaterials and Biomolecules for TEMPs
Current Stage
Ref Project

Relations

Replaces
ASTM F2027-00 - Standard Guide for Characterization and Testing of Substrate Materials for Tissue-Engineered Medical Products
Effective Date
10-May-2000
Replaced By
ASTM F2027-08 - Standard Guide for Characterization and Testing of Raw or Starting Biomaterials for Tissue-Engineered Medical Products
Effective Date
01-May-2008
Referred By
ASTM F3163-22 - Standard Guide for Categories and Terminology of Cellular and/or Tissue-Based Products (CTPs) for Skin Wounds
Effective Date
10-May-2000
Referred By
ASTM F3274-21 - Standard Guide for Testing and Characterization of Alginate Foam Scaffolds Used in Tissue-Engineered Medical Products (TEMPs)
Effective Date
10-May-2000
Referred By
ASTM F2211-13(2021) - Standard Classification for Tissue-Engineered Medical Products (TEMPs)
Effective Date
10-May-2000
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
10-May-2000
Referred By
ASTM F3510-21 - Standard Guide for Characterizing Fiber-Based Constructs for Tissue-Engineered Medical Products
Effective Date
10-May-2000

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ASTM F2027-00e1 - Standard Guide for Characterization and Testing of Substrate Materials for Tissue-Engineered Medical ProductsASTM F2027-00e1 - Standard Guide for Characterization and Testing of Substrate Materials for Tissue-Engineered Medical Products
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ASTM F2027-00e1 - Standard Guide for Characterization and Testing of Substrate Materials for Tissue-Engineered Medical Products
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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
e1
Designation:F2027–00
Standard Guide for
Characterization and Testing of Substrate Materials for
1
Tissue-Engineered Medical Products
This standard is issued under the fixed designation F 2027; 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 (e) indicates an editorial change since the last revision or reapproval.
1
e NOTE—Table 1 was editorially corrected in June 2001.
1. Scope F 665 Classification for Vinyl Chloride Plastics Used in
5
Biomedical Application
1.1 This guide addresses material characteristics of raw or
F 702 Specification for Polysulfone Resin for Medical Ap-
virgin materials in a nonfabricated form that will ultimately
5
plications
undergoadditionalprocessingintogrowth,support,ordelivery
F 748 Practice for Selecting Generic Biological Test Meth-
vehicles for cells or biomolecules.This guide does not apply to
5
ods for Materials and Devices
packaged, sterilized, and finished tissue-engineered medical
F 749 Practice for Evaluating Material Extracts by Intracu-
products.
5
taneous Injection in the Rabbit
1.2 The purpose of the guide is to assist the developer of
F 755 Specification for Selection of Porous Polyethylene
tissue-engineered medical products to locate relevant existing
5
for Use in Surgical Implants
standards and test methods and to provide guidance for interim
F 756 Practice for Assessment of Hemolytic Properties of
use of materials for which a standard does not exist.
5
Materials
2. Referenced Documents
F 763 Practice for Short-Term Screening of Implant Mate-
5
rials
2.1 ASTM Standards:
2
F 813 PracticeforDirectContactCellCultureEvaluationof
D 1763 Specification for Epoxy Resins
5
3
Materials for Medical Devices
D 1898 Practice for Sampling of Plastics
F 895 Test Method forAgar Diffusion Cell Culture Screen-
E 1298 Guide for Determination of Purity, Impurities, and
5
4
ing for Cytotoxicity
Contaminants in Biological Drug Products
F 981 Practice for Assessment of Compatibility of Bioma-
F 67 Specification for Unalloyed Titanium for Surgical
5
terials for Surgical Implants with Respect to Effect of
Implant Applications
5
5
Materials on Muscle and Bone
F 451 Specification for Acrylic Bone Cement
F 997 Specification for Polycarbonate Resin for Medical
F 560 Specification for Unalloyed Tantalum for Surgical
3
5
Applications
Implant Applications
F 1088 Specification for Beta-Tricalcium Phosphate for
F 603 Specification for High-Purity Dense Aluminum Ox-
5
5
Surgical Implantation
ide for Surgical Implant Application
F 1185 Specification for Composition of Ceramic Hydroxy-
F 604 Specification for Silicone Elastomers Used in Medi-
5
5
lapatite for Surgical Implants
cal Applications
F 1251 Terminology Relating to Polymeric Biomaterials in
F 624 Guide for Evaluation of Thermoplastic Polyurethane
5
5
Medical and Surgical Devices
Solids and Solutions for Biomedical Applications
F 1425 Specification for Virgin Poly (L-lactic Acid) Resin
F 641 Specification for Implantable Epoxy Electronic En-
3
5
for Surgical Implants
capsulants
F 1439 Guide for Performance of Lifetime Bioassay for the
5
Tumorigenic Potential of Implant Materials
F 1472 Specification for Wrought Ti-6Al-4VAlloy for Sur-
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
5
gical Implant Applications
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F 1579 Specification for Polyaryletherketone (PAEK) Res-
F04.42 on Tissue Characterization.
5
Current edition approved May 10, 2000. Published August 2000.
ins for Surgical Implant Applications
2
Annual Book of ASTM Standards, Vol 08.01.
F 1581 Specification for Composition of Anorganic Bone
3
Discontinued; see 1997 Annual Book of ASTM Standards, Vol 08.01.
5
4
for Surgical Implants
Annual Book of ASTM Standards, Vol 11.05.
5
Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
e1
F2027–00
F 1634 Practice for In Vitro Environmental Conditioning of 3. Terminology
Polymer Matrix Composite Materials and Implant De-
3.1 Definitions:
5
vices
3.1.1 natural materials, n—synthesized or produced by
F 1635 TestMethodforInVitroDegradationtestingofPoly
living cells.
(L-Lactic Acid) Resin and Fabricated Forms for Surgical
3.1.2 substrates, n—raw or virgin materials that will ulti-
5
Implants
mately be used in tissue-engineered medical products for
F 1855 Specification for Polyoxymethylene Acetal for
growth, support, or delivery of cells or biomolecules.
5
Medical Applications
F 1876 Standard Specification for Polyetherketoneetherke-
4. Descriptive Chemical and Phy
...

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ASTM F2777-23(Test Method)
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4.1 This test method can be used to describe the effects of materials, manufacturing, and design variables on the fatigue/cyclic creep performance of UHMWPE bearing components subject to substantial rotation in the transverse plane (relative to the tibial tray) for a relatively large number of cycles.  
4.2 The loading and kinematics of bearing component designs in vivo will, in general, differ from the loading and kinematics defined in this test method. The results obtained here cannot be used to directly predict in vivo performance. However, this test method is designed to enable comparisons between the fatigue performance of different bearing component designs when tested under similar conditions.  
4.3 The test described is applicable to any bicompartmental knee design, including mobile bearing knees that have mechanisms in the tibial articulating component to constrain the posterior movement of the femoral component and a built-in retention mechanism to keep the articulating component on the tibial plate.
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1.1 This standard specifies a test method for determining the endurance properties and deformation, under specified laboratory conditions, of ultra high molecular weight polyethylene (UHMWPE) tibial bearing components used in bicompartmental or tricompartmental knee prosthesis designs.  
1.2 This test method is intended to simulate near posterior edge loading similar to the type of loading that would occur during high flexion motions such as squatting or kneeling.  
1.3 Although the methodology described attempts to identify physiological orientations and loading conditions, the interpretation of results is limited to an in vitro comparison between knee prosthesis designs and their ability to resist deformation and fracture under stated test conditions.  
1.4 This test method applies to bearing components manufactured from UHMWPE.  
1.5 This test method could be adapted to address unicompartmental total knee replacement (TKR) systems, provided that the designs of the unicompartmental systems have sufficient constraint to allow use of this test method. This test method does not include instructions for testing two unicompartmental knees as a bicompartmental system.  
1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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This specification covers chemical, mechanical, and metallurgical general requirements for metal injection molded (MIM) cobalt-28chromium-6molybddenum components to be used in manufacturing surgical implants. In this specification, the MIM components covered may have been densified beyond their as-sintered density by post-sinter processing. For the chemical requirements, the components supplied in this specification must conform in accordance to the chemical requirements specified herein in Table 1. The product analysis tolerances must also conform to the product tolerances presented in Table 2. The specification also enumerates the mechanical requirements for MIM components wherein the tensile properties of the MIM must conform to the mechanical properties in Table 3. The microstructural requirements and specimen preparation shall be in accordance with Guide E3 and Practice E407.
SCOPE
1.1 This specification covers chemical, mechanical, and metallurgical requirements for metal injection molded (MIM) cobalt-28chromium-6molybdenum components to be used in the manufacture of surgical implants  
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1.4 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.

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ASTM F3140-23(Test Method)
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4.1 This test method can be used to describe the effects of materials, manufacturing, and design variables on the fatigue performance of metallic tibial trays subject to cyclic loading for relatively large numbers of cycles.  
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1.3 This test method may require modifications to accommodate other tibial tray designs.  
1.4 This test method is intended to provide useful, consistent, and reproducible information about the fatigue performance of metallic tibial trays with unsupported mid-section of the condyle.  
1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
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1.1 This specification covers the material requirements for calcium phosphate coatings for surgical implant applications.  
1.2 In particulate and monolithic form, the calcium phosphate materials system has been well characterized regarding biological response (1, 2)2 and laboratory characterization (2-4). Several publications (5-10) have documented the in vitro and in vivo properties of selected calcium phosphate coating systems.  
1.3 This specification covers hydroxylapatite coatings, other calcium phosphate (for example, octacalcium calcium phosphate, amorphous calcium phosphate, dicalcium phosphate dihydrate) coatings, or a coating containing a combination of two or more calcium phosphate phases, with or without intentional minor additions of other elements or compounds (for example, fluorine, manganese, magnesium, carbonate),3 and applied by methods including, but not limited to, the following: (1) plasma spray deposition, (2) solution precipitation, (3) dipping/sintering, (4) electrophoretic deposition, and (5) sputtering.  
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1.6 This specification excludes organic coatings that may contain calcium and phosphate ionic species.  
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Standard Guide for Total Knee Replacement Loading Profiles

SIGNIFICANCE AND USE
4.1 The purpose of this test guide is to provide load profile information on how one could test a total knee replacement in order to evaluate in vitro its function and wear during several types of knee motions as described in 4.2 and 4.3.  
4.2 This test guide may help characterize the magnitude and location of implant wear as an implant is repetitively moved according to specified load and displacement waveforms.  
4.3 This test guide may also help characterize the functional limitations of a total knee replacement as its motion is guided by these waveforms. These limitations may be observed as impingement, subluxation, or high loading in the soft tissue constraints, whether they are represented physically or virtually.  
4.4 The motions and load conditions in vivo will, in general, differ from the load and motions defined in this guide. The results obtained from this guide cannot be used to directly predict in vivo performance. However, this guide is designed to allow for comparisons in performance of different knee designs, when tested under similar conditions.
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1.2 This document provides guidance for functional simulation that could be used to evaluate in vitro the durability of knee prosthetic devices under force control.  
1.3 Function simulation is defined as the reproduction of loads and motions that might be encountered in activities of daily living, but it does not necessarily cover every possible type of loading. Functional simulation differs from typical wear testing in that it attempts to exercise the prosthetic device through a variety of loading and motion conditions such as might be encountered in situ in the human body in order to reveal various damage modes and damage mechanisms that might be encountered throughout the life of the prosthetic device.  
1.4 Force control is defined as the mode of control of the test machine that accepts a force level as the set point input and which utilizes a force feedback signal in a control loop to achieve that set point input. For knee simulation, the flexion motion is placed under angular displacement control, internal and external rotation is placed under torque control, and axial load, anterior-posterior shear, and medial-lateral shear are placed under force control.  
1.5 This document establishes kinetic and kinematic test conditions for several activities of daily living, including walking, turning navigational movements, stair climbing, stair descent, and squatting. The kinetic and kinematic test conditions are expressed as reference waveforms used to drive the relevant simulator machine actuators. These waveforms represent motion, as in the case of flexion extension, or kinetic signals representing the forces and moments resulting from body dynamics, gravitation, and the active musculature acting across the knee.  
1.6 This document does not address the assessment or measurement of damage modes, or wear or failure of the prosthetic device.  
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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ASTM F3047M-23(Guide)
Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations

SIGNIFICANCE AND USE
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.
SCOPE
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.  
1.2 Hard-on-hard hip bearing systems include metal-on-metal (for example, Specifications F75, F799, and F1537; ISO 5832-4, ISO 5832-12), ceramic-on-ceramic (for example, ISO 6474-1, ISO 6474-2, ISO 13356), ceramic-on-metal, or any other bearing systems where both the head and cup components have high surface hardness. An argument has been made that the hard-on-hard THR articulation may be better for younger, more active patients. These younger patients may be more physically fit and expect to be able to perform more energetic activities. Consequently, new designs of hard-on-hard THR articulations may have some implantations subjected to more demanding and longer wear performance requirements.  
1.3 Total Hip Replacement (THR) with metal-on-metal articulations have been used clinically for more than 50 years (1, 2).2 Early designs had mixed clinical results. Eventually they were eclipsed by THR systems using metal-on-polyethylene articulations. In the 1990s the metal-on-metal articulation again became popular with more modern designs (3), including surface replacement.  
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1.5 The values stated in SI units are to be regarded as the standard.  
1.6 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.

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ASTM F543-23(Specification)
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
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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
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  • Technical specification
    22 pages
    English language
    sale 15% off