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ASTM F981-04

(Practice)

Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

SIGNIFICANCE AND USE
This practice covers a test protocol for comparing the local tissue response evoked by biomaterials, from which medical implantable devices might ultimately be fabricated, with the local tissue response elicited by control materials currently accepted for the fabrication of surgical devices. The materials may include metals (and metal alloys), dense aluminum oxide, and polyethylene that are standardized on the basis of acceptable long-term well-characterized long-term response. The controls consistently produce cellular reaction and wound healing to a degree that has been found to be acceptable to the host.
SCOPE
1.1 This practice provides a series of experimental protocols for biological assays of tissue reaction to nonabsorbable biomaterials for surgical implants. It assesses the effects of the material on animal tissue in which it is implanted. The experimental protocol is not designed to provide a comprehensive assessment of the systemic toxicity, immune response, carcinogenicity, teratogenicity, or mutagenicity of the material since other standards deal with these issues. It applies only to materials with projected applications in humans where the materials will reside in bone or soft tissue in excess of 30 days and will remain unabsorbed. It is recommended that short-term assays, according to Practice F 763, first be performed. Applications in other organ systems or tissues may be inappropriate and are therefore excluded. Control materials will consist of any one of the metal alloys in Specifications F 67, F 75, F 90, F 136, F 138, or F 562, high purity dense aluminum oxide as described in Specification F 603, ultra high molecular weight polyethylene as stated in Specification F 648 or USP polyethylene negative control.
1.2 This practice is a combination of Practice F 361 - 80 and Practice F 469 - 78. The purpose, basic procedure, and method of evaluation of each type of material are similar; therefore, they have been combined.
1.3 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-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 F981-99(2003) - Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
Effective Date
01-May-2004
Replaced By
ASTM F981-04(2010) - Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
Effective Date
01-Jun-2010
Referred By
ASTM F561-19 - Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
Effective Date
01-May-2004
Referred By
ASTM F90-23 - Standard Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS R30605)
Effective Date
01-May-2004
Referred By
ASTM F3089-23 - Standard Guide for Characterization and Standardization of Polymerizable Collagen-Based Products and Associated Collagen-Cell Interactions
Effective Date
01-May-2004
Referred By
ASTM F3515-21 - Standard Guide for Characterization and Testing of Porcine Fibrinogen as a Starting Material for Use in Biomedical and Tissue-Engineered Medical Product Applications
Effective Date
01-May-2004
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 F2212-20 - Standard Guide for Characterization of Type I Collagen as Starting Material for Surgical Implants and Substrates for Tissue Engineered Medical Products (TEMPs)
Effective Date
01-May-2004
Referred By
ASTM F1350-15 - Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
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 F562-22 - Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035)
Effective Date
01-May-2004
Referred By
ASTM F1185-23 - Standard Specification for Composition of Medical-Grade Hydroxylapatite for Surgical Implants
Effective Date
01-May-2004
Referred By
ASTM F1538-03(2017) - Standard Specification for Glass and Glass Ceramic Biomaterials for Implantation
Effective Date
01-May-2004
Referred By
ASTM F2068-15 - Standard Specification for Femoral Prostheses—Metallic Implants (Withdrawn 2023)
Effective Date
01-May-2004
Referred By
ASTM F1357-23 - Standard Specification for Articulating Total Wrist Implants
Effective Date
01-May-2004

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ASTM F981-04 - Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and BoneASTM F981-04 - Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
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ASTM F981-04 - Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
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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:F981–04
Standard Practice for
Assessment of Compatibility of Biomaterials for Surgical
Implants with Respect to Effect of Materials on Muscle and
1
Bone
ThisstandardisissuedunderthefixeddesignationF981;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 F67 Specification for Unalloyed Titanium, for Surgical
Implant Applications (UNS R50250, UNS R50400, UNS
1.1 Thispracticeprovidesaseriesofexperimentalprotocols
R50550, UNS R50700)
for biological assays of tissue reaction to nonabsorbable
F75 Specification for Cobalt-28 Chromium-6 Molybdenum
biomaterials for surgical implants. It assesses the effects of the
Alloy Castings and Casting Alloy for Surgical Implants
material on animal tissue in which it is implanted. The
(UNS R30075)
experimental protocol is not designed to provide a comprehen-
F86 Practice for Surface Preparation and Marking of Me-
sive assessment of the systemic toxicity, immune response,
tallic Surgical Implants
carcinogenicity, teratogenicity, or mutagenicity of the material
F90 Specification for Wrought Cobalt-20Chromium-
since other standards deal with these issues. It applies only to
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
materials with projected applications in humans where the
tions (UNS R30605)
materials will reside in bone or soft tissue in excess of 30 days
F136 Specification for Wrought Titanium-6Aluminum-
and will remain unabsorbed. It is recommended that short-term
4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical
assays, according to Practice F763, first be performed. Appli-
Implant Applications (UNS R56401)
cations in other organ systems or tissues may be inappropriate
F138 Specification for Wrought 18Chromium-14Nickel-
and are therefore excluded. Control materials will consist of
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
any one of the metal alloys in Specifications F67, F75, F90,
Implants (UNS S31673)
F136, F138,or F562, high purity dense aluminum oxide as
F361 Practice for Assessment of Compatibility of Metallic
described in Specification F603, ultra high molecular weight
Materials for Surgical Implants with Respect to Effect of
polyethylene as stated in Specification F648 or USP polyeth-
3
Materials on Tissue
ylene negative control.
F469 Practice for Assessment of Compatibility of Nonpo-
1.2 ThispracticeisacombinationofPracticeF361 – 80and
rous Polymeric Materials for Surgical Implants with Re-
Practice F469 – 78. The purpose, basic procedure, and method
3
gard to Effect of Materials on Tissue
of evaluation of each type of material are similar; therefore,
F562 Specification for Wrought 35Cobalt-35Nickel-
they have been combined.
20Chromium-10Molybdenum Alloy for Surgical Implant
1.3 This standard does not purport to address all of the
Applications (UNS R30035)
safety concerns, if any, associated with its use. It is the
F603 Specification for High-Purity DenseAluminum Oxide
responsibility of the user of this standard to establish appro-
4
for Medical Application
priate safety and health practices and determine the applica-
F648 Specification for Ultra-High-Molecular-Weight Poly-
bility of regulatory limitations prior to use.
ethylene Powder and Fabricated Form for Surgical Im-
2. Referenced Documents plants
2
F763 Practice for Short-Term Screening of Implant Materi-
2.1 ASTM Standards:
als
3. Summary of Practice
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
3.1 This practice describes the preparation of implants, the
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.16 on Biocompatibility Test Methods.
number of implants and test hosts, test sites, exposure sched-
Current edition approved May 1, 2004. Published June 2004. Originally
ule, implant sterilization techniques, and methods of implant
approved in 1986. Last previous edition approved in 2003 as F981 – 99 (2003).
DOI: 10.1520/F0981-04.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
3
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Withdrawn.
4
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 ----------------------
F981–04
retrieval and tissue examination of each test site. Histological 6.3.1 The implants shall be cylindrical in shape and may
criteria for evaluating tissue reaction ar
...

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3.1 The compression resistance perpendicular to the faces, the resistance to the extrusion during compression, and the ability to recover after release of the load are indicative of a joint filler's ability to continuously fill a concrete expansion joint and thereby prevent damage that might otherwise occur during thermal expansion. The asphalt content is a measure of the fiber-type joint filler's durability and life expectancy. In the case of cork-type fillers, the resistance to water absorption and resistance to boiling hydrochloric acid are relative measures of durability and life expectancy.
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SCOPE
1.1 These test methods cover the physical properties associated with preformed expansion joint fillers. The test methods include:    
Property  
Section  
Expansion in Boiling Water  
7.1  
Recovery and Compression  
7.2  
Extrusion  
7.3  
Boiling in Hydrochloric Acid  
7.4  
Asphalt Content  
7.5  
Water Absorption  
7.6  
Density  
7.7
Note 1: Specific test methods are applicable only to certain types of joint fillers, as stated herein.  
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SCOPE
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