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ASTM F763-04

(Practice)

Standard Practice for Short-Term Screening of Implant Materials

Standard Practice for Short-Term Screening of Implant Materials

SIGNIFICANCE AND USE
The use of in vivo implantation techniques for characterizing the biocompatibility of materials to be utilized in various medical applications provides a unique assessment of such materials not achieved by other procedures. Physical characteristics (that is, form, density, hardness, surface finish) can influence the character of the tissue response to the test materials.
This practice is intended as a rapid screening procedure for determining the acceptability of candidate materials. It would be invoked prior to using the long-term tests described in Practice F 981. It is understood that for some applications additional tests, including long-term implantation studies, may be required to assess the final suitability of the candidate materials.
This practice may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested, their potential applications, and the recommendations contained in Practice F 748.
SCOPE
1.1 This practice provides guidelines for short-term testing or screening of candidate materials, both porous and dense, as to the effects of the material on animal tissue in which it is implanted. This is a rapid screening prodedure for determining acceptability of candidate materials.
1.2 This practice, along with other appropriate biological tests (including other appropriate ASTM tests) may be used in the biocompatibility assessment of the candidate materials for use in the fabrication of devices for clinical application.
1.3 This experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, carcinogenicity, teratogenicity, or mutagenicity of the material since other standards deal with these issues.
1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F 748 provides guidance for the selection of appropriate methods for testing materials for a specific application.

General Information

Status
Historical
Publication Date
30-Apr-2004
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.16 - Biocompatibility Test Methods
Current Stage
Ref Project

Relations

Replaces
ASTM F763-99(2003) - Standard Practice for Short-Term Screening of Implant Materials
Effective Date
01-May-2004
Replaced By
ASTM F763-04(2010) - Standard Practice for Short-Term Screening of Implant Materials
Effective Date
01-Jun-2010
Referred By
ASTM F648-21 - Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
Effective Date
01-May-2004
Referred By
ASTM F748-16 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
Effective Date
01-May-2004
Referred By
ASTM F2565-21 - Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications
Effective Date
01-May-2004
Referred By
ASTM F2695-12(2020) - Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications
Effective Date
01-May-2004
Referred By
ASTM F451-21 - Standard Specification for Acrylic Bone Cement
Effective Date
01-May-2004
Referred By
ASTM F981-23 - Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
Effective Date
01-May-2004
Referred By
ASTM E3219-20 - Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)
Effective Date
01-May-2004
Referred By
ASTM F1983-23 - Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
Effective Date
01-May-2004
Referred By
ASTM F2759-19 - Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
Effective Date
01-May-2004
Referred By
ASTM F2347-15 - Standard Guide for Characterization and Testing of Hyaluronan as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
Effective Date
01-May-2004
Referred By
ASTM F1408-20a - Standard Practice for Subcutaneous Screening Test for Implant Materials
Effective Date
01-May-2004
Referred By
ASTM F2064-17 - Standard Guide for Characterization and Testing of Alginates as Starting Materials Intended for Use in Biomedical and Tissue Engineered Medical Product Applications
Effective Date
01-May-2004
Referred By
ASTM F2103-18 - Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications
Effective Date
01-May-2004

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ASTM F763-04 - Standard Practice for Short-Term Screening of Implant MaterialsASTM F763-04 - Standard Practice for Short-Term Screening of Implant Materials
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ASTM F763-04 - Standard Practice for Short-Term Screening of Implant Materials
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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: F763 – 04
Standard Practice for
1
Short-Term Screening of Implant Materials
ThisstandardisissuedunderthefixeddesignationF763;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope Implants (UNS S31673)
F562 Specification for Wrought 35Cobalt-35Nickel-
1.1 This practice provides guidelines for short-term testing
20Chromium-10Molybdenum Alloy for Surgical Implant
or screening of candidate materials, both porous and dense, as
Applications (UNS R30035)
to the effects of the material on animal tissue in which it is
F563 Specification for Wrought Cobalt-20Nickel-
implanted. This is a rapid screening prodedure for determining
20Chromium-3.5Molybdenum-3.5Tungsten-5Iron Alloy
acceptability of candidate materials.
3
for Surgical Implant Applications (UNS R30563)
1.2 This practice, along with other appropriate biological
F603 Specification for High-Purity DenseAluminum Oxide
tests (including other appropriateASTM tests) may be used in
3
for Medical Application
the biocompatibility assessment of the candidate materials for
F648 Specification for Ultra-High-Molecular-Weight Poly-
use in the fabrication of devices for clinical application.
ethylene Powder and Fabricated Form for Surgical Im-
1.3 This experimental protocol is not designed to provide a
plants
comprehensive assessment of the systemic toxicity, carcinoge-
F748 Practice for Selecting Generic Biological Test Meth-
nicity, teratogenicity, or mutagenicity of the material since
ods for Materials and Devices
other standards deal with these issues.
F981 Practice forAssessment of Compatibility of Biomate-
1.4 This practice is one of several developed for the
rials for Surgical Implants with Respect to Effect of
assessment of the biocompatibility of materials. Practice F748
Materials on Muscle and Bone
provides guidance for the selection of appropriate methods for
testing materials for a specific application.
3. Terminology
2. Referenced Documents 3.1 Description of a Term Specific to this Standard:
2
3.1.1 biocompatibility assay—a comparison of the tissue
2.1 ASTM Standards:
response produced through the close association of the im-
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
planted candidate material to its implant site within the host
Alloy Castings and Casting Alloy for Surgical Implants
animal to that tissue response recognized and established as
(UNS R30075)
suitable with control materials.
F86 Practice for Surface Preparation and Marking of Me-
tallic Surgical Implants
4. Summary of Practice
F90 Specification for Wrought Cobalt-20Chromium-
4.1 Under aseptic conditions, test specimens of the candi-
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
date material and of controls are inserted into a muscle or
tions (UNS R30605)
group of muscles of the animal host.After a period of time the
F136 Specification for Wrought Titanium-6Aluminum-
animals are euthanized. The tissue reactions to implants of the
4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical
candidate material during the acute to subchronic time period
Implant Applications (UNS R56401)
of healing are compared with tissue reactions to control
F138 Specification for Wrought 18Chromium-14Nickel-
materials which have a well characterized response. The
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
implants are not subject to major stress while in situ.
1
5. Significance and Use
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
Surgical Materials and Devices and is the direct responsibility of Subcommittee
5.1 The use of in vivo implantation techniques for charac-
F04.16 on Biocompatibility Test Methods.
terizing the biocompatibility of materials to be utilized in
Current edition approved May 1, 2004. Published June 2004. Originally
approved in 1982. Last previous edition approved in 2003 as F763 – 99 (2003). various medical applications provides a unique assessment of
DOI: 10.1520/F0763-04.
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
3
Standards volume information, refer to the standard’s Document Summary page on Withdrawn. The last approved version of this historical standard is referenced
the ASTM website. on www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
F763 – 04
such materials not achieved by other procedures. Physical 7.2 Implantsizesarelefttothediscretionoftheinvestigator.
characteristics (that is, form, densi
...

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This specification covers UNS N06002, UNS N06030, UNS N06035, UNS N06022, UNS N06200, UNS N06230, UNS N06600, UNS N06617, UNS N06625, UNS N08020, UNS N08026, UNS N08024, UNS N08120, UNS N08926, UNS N08367, UNS N10242, UNS N10276, UNS N10665, UNS N10675, UNS N12160, UNS R20033, UNS N06059, UNS N06686, UNS N10629, UNS N08031, UNS N06045, UNS N06025, and UNS R30556 nickel alloy billets and bars for reforging. The products shall be hot worked from ingots by rolling, forging, extruding, hammering, or pressing. The material shall conform to the chemical composition requirements prescribed by the reference material. The chemical composition of the material shall be determined by chemical analysis in accordance with test method E1473.
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1.1 This specification covers UNS N06002, UNS N06030, UNS N06035, UNS N06022, UNS N06200, UNS N10362, UNS N06230, UNS N06600, UNS N06617, UNS N06625, UNS N08020, UNS N08026, UNS N08024, UNS N08120, UNS N08926, UNS N08367, UNS N10242, UNS N10276, UNS N10665, UNS N10675, UNS N12160, UNS R20033, UNS N06059, UNS N06686, UNS N10629, UNS N08031, UNS N06045, UNS N06025, UNS N06699, and UNS R305562 billets and bars for reforging.  
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