ASTM F2977 - 20 - Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants

ASTM F2977 - 20

Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants

Status : Current   Published : April 2020



1.1 This test method covers the determination of mechanical behavior of polymericbiomaterials by small punch testing of miniature disk specimens (0.5 mm in thicknessand 6.4 mm in diameter). The test method has been established for characterizingsurgical materials after ram extrusion or compression molding (1-3) 2; forevaluating as-manufactured implants and sterilization method effects (4, 5);as well as for testing of implants that have been retrieved (explanted) from thehuman body (6, 7).

1.2 The results of the small punch test, namely the peak load, ultimate displacement,ultimate load, and work to failure, provide metrics of the yielding, ultimatestrength, ductility, and toughness under multiaxial loading conditions. Because themechanical behavior can be different when loaded under uniaxial and multiaxialloading conditions (8), the small punch test provides a complementarymechanical testing technique to the uniaxial tensile test. However, it should benoted that the small punch test results may not correlate with uniaxial tensile testresults.

1.3 In addition to its use as a research tool in implant retrieval analysis, thesmall punch test can be used as a laboratory screening test to evaluate newmaterials with minimal material waste (1).

1.4 The small punch test has been applied to other polymers, including polymethylmethacrylate (PMMA) bone cement, polyacetal, and high density polyethylene (HDPE),ultra high molecular weight polyethylene (UHMWPE), and polyetheretherketone (PEEK)(2, 3, 5, 9, 10). This standard outlines general guidelines for the smallpunch testing of implantable polymers.

1.5 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 standardto establish appropriate safety, health, and environmental practices anddetermine the applicability of regulatory limitations prior to use.

1.6 This international standard was developed in accordance with internationallyrecognized principles on standardization established in the Decision onPrinciples for the Development of International Standards, Guides andRecommendations issued by the World Trade Organization Technical Barriers toTrade (TBT) Committee.

Standard NumberASTM F2977 - 20
TitleStandard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants
Publication Date01 April 2020
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)No other standards are informatively referenced
Descriptors mechanical behavior, miniature specimens, polyetheretherketone (PEEK), polymethyl methacrylate (PMMA) bone cement, small punch test, UHMWPE, ultra-high molecular weight polyethylene
File Size168 KB

 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents

Develop a PAS

Develop a fast-track standardization document in 9-12 months


Access, view and download standards with multiple user access, across multiple sites with BSOL

Worldwide Standards
We can source any standard from anywhere in the world