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Biomedical Materials Reference Data

 

Ultra High Molecular Weight Polyethylene (UHMWPE) Reference Material 8456

About Property Data Summaries.

Database Reference:

https://srmors.nist.gov/certificates/8456.pdf?CFID=111836&CFTOKEN=d456d0f5e7732bda-E81E8C50-A5AA-7E42-0279289888B3006A&jsessionid=b4301698541090521042000 RM 8456.

Journal References: Not included

Other materials: Property Data Summaries

 
Material Summary:


RM 8456 is medical grade UHMWPE, stearate-free. Mechanical properties are given for RM 8456. They have been evaluated to serve as a guide in assessing the uniformity of the material. The mechanical properties evaluated at NIST are shown in Table 1 of properties and are given with the expanded uncertainty of the measurements of tensile specimens taken from bars supplied by the manufacturer. Reference values and uncertainties for Young’s modulus, yield strength, ultimate strength, and elongation are shown in Table 1. Reference values are noncertified values that are the best estimate of the true value; however, the values do not meet the NIST criteria for certification and are provided with associated uncertainties that may not include all sources of uncertainty. Other properties given are stated by the manufacturer that supplied the materials as complying with ASTM Specification F648:

F648-00e1 Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants

 

Property Summary:

For references to the source data and detailed discussions of the properties, please go directly to the Certificate of Analysis for RM 8456:

https://srmors.nist.gov/certificates/8456.pdf?CFID=111836&CFTOKEN=d456d0f5e7732bda-E81E8C50-A5AA-7E42-0279289888B3006A&jsessionid=b4301698541090521042000

For a table that provides options for viewing the Certificate of Analysis, a registration card for purchases, and links to other RMs and SRMs, go to:

https://srmors.nist.gov/view_cert.cfm?srm=8456

Special Notes on Properties:

The Mechanical Properties were obtained with the following test protocol:

• Specimen fixed in grips starting at a zero load.

• Crosshead speed set at 50 mm/min.

• Load cell and extensometer specifications as described in ASTM D 638-96, calibrated every 10 tests electronically, both before and after the testing session,

with dead weights.

• Data collection rate set at maximum for the instrument.

Data Status: Validated (V)

Except where noted otherwise:

a) The uncertainty ,u, given is, u = standard deviation (SD) of measurements with a coverage factor of 2; i.e.;

u = 2 x SD, which approximates a 95 % confidence interval.

Structure: UHMWPE is a semi-crystalline polyolefin polymer. The bars that constitute RM 8456 were formed by ram-extrusion of particles of UHMWPE that the manufacturer states are less than # 16 sieve size (ASTM-E11 )which allows particles less than 1.180 mm in diameter to pass through (the particles themselves are formed by the polymerization of ethylene and in a consolidated state, in the consolidated form these particles are referred to as grains).


Tribology Characteristics:

The wear behavior of RM 8456 was not determined because UHMWPE is used for medical joint applications after it has been exposed to ionizing radiation, either to sterilize the material or to improve its wear resistance (or to achieve both results). The amount and kind of ionizing radiation treatments vary considerably among manufacturers of orthopaedic joint prostheses. Published results may be found at links that follow the disclaimers.

DISCLAIMERS:
A substantial effort has been made to select links from this database on the basis of sound scientific judgment. However, the National Institute of Standards and Technology (NIST) makes no warranties regarding their uses, and NIST shall not be liable for any damage that may result from errors or omissions in the database.

Certain trade names and other commercial designations are used in this work for the purpose of clarity. In no case does such identification imply endorsement by the National Institute of Standards and Technology, nor does it imply that products or services so identified are necessarily the best available for the purpose.

External Links at which you may find other data on medical grade UHMWPE:

 
J. Biomedical Materials Research Part A:

J. Biomedical Materials Research Part B: Applied Biomaterials:

J. Orthopaedic Research:

J. Am. Academy Orthopaedic Surgeons:

e J. Bone & Joint Surgery

UHMWPE Lexicon

 

Property Table 1
 
The values presented. Estimated combined relative standard uncertainties of the property values are listed in the second column. For example, a value of 6.0 with ur = 5 % is equivalent to 6.0 +/- 0.30. A question mark, (?), for ur means the uncertainty could not be determined with the available data.

 

Property [unit]

23 °C ± 1 °C

ur [%]a

Standard Deviation

SD, n specimens

Data Status

Bulk Modulus [GPa]

 

 

 

 

Compressive Strength [GPa]

 

 

 

 

Creep Rate [10-9 s-1]

 

 

 

 

Density [kg/m3]

932

?

 

 

Young’s Modulus [MPa]

1258

44

22

V

Secant Modulus (Mean) MPa @ 0 % to 1 % strain

945

 

19 (n=10)

V

Secant Modulus (Mean) MPa @ 0 % to 2 % strain

678

 

18 (n=10)

V

Secant Modulus (Mean) Mpa @ 0 % to 3 % strain

532

 

12 (n=10)

V

Yield Strength [MPa]

23.56

66

22

V

Ultimate Tensile Strength [MPa]

45.8

6

3

V

Hardness [Shore D]

69

?

 

 

Viscosity Number [mL/g]

3600

?

 

 

Relative Ash Mass [%]

.01

?

 

 

Calcium  [mg/kg]

0

?

 

 

Aluminum  [mg/kg]

7

?

 

 

Chlorine  [mg/kg]

20

?

 

 

 Titanium 18 [mg/kg]

18

?

 

 

Total Trace Element Content [mg/kg]

46

?

 

 

Extraneous Matter [µm]

≤ 300

6

 

 

 
 
 
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Date created: 04 December 2003
Last updated: 22 July 2004


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