ASTM F648-00

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

SCOPE
1.1 This specification covers ultra-high-molecular-weight polyethylene powder (UHMWPE) intended for use in surgical implants.  
1.2 The requirements of this specification apply to UHMWPE in two forms. One is virgin polymer powder (Section 4). The second is any form fabricated from this powder from which a finished product is subsequently produced (Section 5). This specification addresses material characteristics and does not apply to the packaged and sterilized finished implant.  
1.3 The provisions of Specification D4020 apply. Special requirements detailed in this specification are added to describe material which will be used in surgical implants.  
1.4 The biological response to polyethylene in soft tissue and bone has been well characterized by a history of clinical use (1,2,3) and by laboratory studies (4,5,6).  
1.5 The following precautionary caveat pertains only to the test method portion, Section 7, of this specification: 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: 09-May-2000
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.11 - Polymeric Materials

Relations

• Replaced By: ASTM F648-00e1 - Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
• Effective Date: 10-May-2000
• Referred By: ASTM F1408-20a - Standard Practice for Subcutaneous Screening Test for Implant Materials
• Effective Date: 10-May-2000
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 10-May-2000
• Referred By: ASTM F2224-09(2020) - Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
• Effective Date: 10-May-2000
• 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: 10-May-2000
• Referred By: ASTM F2003-02(2022) - Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene After Gamma Irradiation in Air
• Effective Date: 10-May-2000
• Referred By: ASTM F1378-18e1 - Standard Specification for Shoulder Prostheses
• Effective Date: 10-May-2000
• Referred By: ASTM F2193-20 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
• Effective Date: 10-May-2000
• Referred By: ASTM F2027-16 - Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products
• Effective Date: 10-May-2000
• Referred By: ASTM F2848-21 - Standard Specification for Medical-Grade Ultra-High-Molecular-Weight Polyethylene Yarns
• Effective Date: 10-May-2000
• Referred By: ASTM F1714-96(2018) - Standard Guide for Gravimetric Wear Assessment of Prosthetic Hip Designs in Simulator Devices
• Effective Date: 10-May-2000
• 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: 10-May-2000
• Referred By: ASTM F2887-23 - Standard Specification for Total Elbow Prostheses
• Effective Date: 10-May-2000
• Referred By: ASTM F1814-22 - Standard Guide for Evaluating Modular Hip and Knee Joint Components
• Effective Date: 10-May-2000
• Referred By: ASTM F732-17 - Standard Test Method for Wear Testing of Polymeric Materials Used in Total Joint Prostheses
• Effective Date: 10-May-2000

Standards Content (Sample)

NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 648 – 00
Standard Specification for
Ultra-High-Molecular-Weight Polyethylene Powder and
Fabricated Form for Surgical Implants
This standard is issued under the fixed designation F 648; 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. Scope D 1505 Test Method for Density of Plastics by the Density-
Gradient Technique
1.1 This specification covers Ultra-High Molecular Weight
D 1898 Practice for Sampling of Plastics
Polyethylene powder (UHMWPE) and fabricated forms in-
D 4020 Specification for Ultra-High Molecular Weight
tended for use in surgical implants.
Polyethylene Molding and Extrusion Materials
1.2 The requirements of this specification apply to UHM-
F 619 Practice for Extraction of Medical Plastics
WPE in two forms. One is virgin polymer powder (Section 4).
F 748 Practice for Selecting Generic Biological Test Meth-
The second is any form fabricated from this powder from
ods for Materials and Devices
which a finished product is subsequently produced (Section 5).
F 749 Practice for Evaluating Material Extracts by Intracu-
This specification addresses material characteristics and does
taneous Injection in the Rabbit
not apply to the packaged and sterilized finished implant.
F 756 Practice for Assessment of Hemolytic Properties of
1.3 The provisions of Specification D 4020 apply. Special
Materials
requirements detailed in this specification are added to describe
F 763 Practice for Short-Term Screening of Implant Mate-
material which will be used in surgical implants.
rials
1.4 The biological response to polyethylene in soft tissue
F 813 Practice for Direct Contact Cell Culture Evaluation of
and bone has been well characterized by a history of clinical
Materials for Medical Devices
use (1, 2, 3) and by laboratory studies (4, 5, 6).
F 895 Test Method for Agar Diffusion Cell Culture Screen-
1.5 The following precautionary caveat pertains only to the
ing for Cytotoxicity
test method portion, Section 7, of this specification: This
F 981 Practice for Assessment of Compatibility of Bioma-
standard does not purport to address all of the safety concerns,
terials (Nonporous) for Surgical Implants with Respect to
if any, associated with its use. It is the responsibility of the user
Effect of Materials on Muscle and Bone
of this standard to establish appropriate safety and health
2.2 ISO Standards
practices and determine the applicability of regulatory limita-
ISO 527 Plastics: Determination of Tensile Properties
tions prior to use.
ISO 3451-1 Plastics—Determination of Ash, Part 1: Gen-
2. Referenced Documents eral Methods
ISO 11542/2, Plastics—Ultra-High Molecular Weight Poly-
2.1 ASTM Standards:
ethylene (UHMWPE) Moulding and Extrusion
D 256 Test for Impact Resistance of Plastics and Electrical
Materials—Part 2: Preparation of Test Specimens and
Insulating Materials
Determination
D 638 Test Method for Tensile Properties of Plastics
D 648 Test Method for Deflection Temperature of Plastics
3. Terminology
Under Flexural Load
3.1 Definitions of Terms Specific to This Standard:
D 790 Test Methods for Flexural Properties of Plastics and
3.1.1 fabricated form—any bulk shape of UHMWPE, fab-
Electrical Insulating Materials
ricated from the virgin polymer powder, used during the
D 792 Test Methods for Specific Gravity (Relative Density)
process of fabricating surgical implants prior to packaging and
and Density by Displacement
sterilization.
3.1.1.1 Discussion—This form results from the application
of heat and pressure to the virgin polymer powder, and the
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.11 on Polymeric material.
Current edition approved May 10, 2000. Published August 2000. Originally
published as F 648 – 96. Last previous edition F 648 – 98. Annual Book of ASTM Standards, Vol 08.02.
2 5
The boldface numbers in parentheses refer to the list of references at the end of Annual Book of ASTM Standards, Vol 13.01.
this specification. Available from American National Standards Institute, 11 W. 42nd St., 13th
Annual Book of ASTM Standards, Vol 08.01. Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F648–00
material characteristics of this form are subject to the appli- 5.2 Physical Requirements:
cable requirements of this specification. In present practice, 5.2.1 Foreign Matter Requirements:
this includes ram-extruded bars or molded blocks from which 5.2.1.1 When 3200 cm is evaluated according to 7.2.2,
the final product form is machined, or a molded shape which is there shall be no more than ten particles of extraneous matter
subsequently trimmed. visible on the surface when visually inspected by normal or
3.1.2 generic property—that property which is determined corrected vision.
solely by the chemical composition and structure of the virgin 5.2.2 Morphology Requirements:
polymer. 5.2.2.1 When evaluated according to Annex A2 the calcu-
3.1.3 morphology index (MI)—material morphology quality lated morphology index (MI) and total surface area examined
shall be described by a morphology index (MI) defined as the shall be reported.
ratio of the total number of Type A and Type B indications (See 5.3 Mechanical Requirements:
Annex A2) to the total surface area examined in cm . 5.3.1 UHMWPE in fabricated form from which implants
3.1.4 Type A non-fused flake—a Type A non-fused flake shall be made shall meet the requirements listed in Table 2.
(A2.4.1 and Fig. A2.1) is an indication visible under conditions 5.3.2 The following mechanical tests may be conducted
described in A2.5.1 that has an essentially complete circum- based on agreement between the vendor and purchaser:
ferential black boundary and a white center. 5.3.2.1 Deflection temperature; Test Method D 648 (1.8
3.1.5 Type B non-fused flake—a Type B non-fused flake MPa), and Flexural modulus; Test Methods D 790 (secant, 2 %
(A2.4.2 and Fig. A2.2) is an indication visible under conditions offset).
described in A2.5.1 that has a partially circumferential black
6. Sampling
boundary that appears to trace out 50 % to 99 % of a flake’s
perimeter. 6.1 Where applicable, the requirements of this specification
3.1.6 virgin polymer powder—the form of UHMWPE as shall be determined for each lot of powder and fabricated form
obtained from the powder manufacturer and prior to fabrication by sampling sizes and procedures according to Practice
into a bulk shape. D 1898, or as agreed upon between the purchaser and seller.
4. Virgin UHMWPE Powder Requirements 7. Test Methods
4.1 Generic Properties: 7.1 UHMWPE Powder:
7.1.1 Determine the solution viscosity number in accor-
4.1.1 The virgin polymer shall be a homopolymer of ethyl-
ene in accordance with Specification D 4020. dance with the method given in Specification D 4020 at a
concentration of 0.02 %.
4.1.2 The resin type and solution viscosity number require-
ments are listed in Table 1. 7.1.2 Determine the amount of extraneous matter by the
following procedure as agreed upon by the purchaser and
4.2 Nongeneric Properties:
4.2.1 When a 300 g sample is prepared and viewed in seller.
7.1.2.1 A 300 g sample is divided into four 75 g samples.
accordance with 7.1.2, there shall be no more particles of
extraneous matter than that specified in Table 1. Place a 75 g sample in each of four 1000 mL Erlenmeyer
flasks, add 400 mL isopropyl alcohol, shake 5 min, and let
4.2.2 To promote uniformity between different lots of poly-
mer powder, concentration limits for trace elements have been settle for 5 min. Count the total number of particles of
extraneous matter in the four flasks.
established and are listed in Table 1.
4.2.3 When determined as described in ISO 3451-1, the
mean ash of duplicate samples shall not exceed the limits
TABLE 2 Requirements for UHMWPE Fabricated Forms
established in Table 1.
Property Test Method Requirement
Resin Type Type 1 Type 2 Type 3
5. UHMWPE Fabricated Form Requirements
Density, kg/m ASTM D 792 or 927-944 927-944 927-944
5.1 Compositional Requirements:
D 1505
5.1.1 No stabilizers or processing aids are to be added to the Ash, mg/kg, (Maximum) ISO 3451-1 150 150 300
Tensile Strength, 23°C, MPa, ASTM D 638, Type
virgin polymer powder during manufacture of a fabricated
A
(Minimum) IV, 5.08 cm/min
form.
Ultimate 35 27 27
Yield ISO 527, 100 mm/ 21 19 19
min.
A
TABLE 1 Requirements for UHMWPE Powders
Elongation, %, (Minimum) ASTM D 638, Type 300 300 250
IV, 5.08 cm/min
Property Test Method Requirement
ISO 527, 100 mm/
Resin Type Type 1 Type 2 Type 3
min.
Izod Impact Strength, kJ/m , Annex A1 126 73 25
Viscosity Number, mL/g, ASTM D 4020 (0.02 %) 2000-3200 >3200 >3200
B
(Minimum)
Ash, mg/kg, (Maximum) ISO 3451-1 150 150 300
Charpy Impact Strength, kJ/ ISO/CD 11542/2.3, 180 90 30
Extraneous Matter, No. 4.2.1 5 5 25
2 B
m , (Minimum) Annex A2
Particles, (Maximum)
A
Titanium, mg/kg, (Maximum) 7.1.3.1 40 40 150 Either Test Method D 638 or ISO 527 may be used to determine tensile
Aluminum, mg/kg, (Maximum)7.1.3.1 40 40 100
strength and elongation, however the ISO 527 method will be considered the
Calcium, mg/kg, (Maximum) 7.1.3.1 50 50 50 referee method.
B
Chlorine, mg/kg, (Maximum) 7.1.3.2 20 75 90
Either Charpy or Izod impact strength may be determined, however, the Charpy
test will be considered the referee method.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F648–00
7.1.2.2 Visually examine (20/20 corrected vision if neces- 7.2.3 Determine the density in accordance with Test Meth-
sary) the four flasks and count the total number of particles of ods D 792 or D 1505.
extraneous matter. 7.2.4 Determine specific mechanical properties in accor-
dance with the methods listed in Table 2. Mechanical test
7.1.3 Determine the following trace element concentrations
specimens shall be produced by methods that represent those
by the following methods, or by methods agreed upon by the
used to produce the fabricated form.
purchaser and seller.
7.2.5 Unless otherwise specified, the testing described in
7.1.3.1 The elements Ti, Al, and Ca may be determined by
Table 2 (except for ash) shall be conducted under standard
atomic absorption (AA) or emission spectroscopy (ES); induc-
conditions of 23 6 2°C after storage of the test specimens for
tively coupled plasma mass spectroscopy (ICP/MS); or induc-
at least 16 h.
tively coupled plasma spectroscopy (ICP).
7.1.3.2 The element chlorine (Cl) may be determined po-
8. Biocompatibility
tentiometrically, titrametrically, by neutron activation analysis,
8.1 This material has been shown to produce a well char-
by inductively coupled plasma mass spectroscopy (ICP/MS),
acterized level of biological response following long term
or by the oxygen bomb combustion/UV-Vis spectroscopy
clinical use in laboratory animals. The results of these studies
method.
and the clinical history indicate an acceptable level of biologi-
7.2 UHMWPE Fabricated Form:
cal response in the applications in which the material has been
7.2.1 The requirement that there will be no addition of any
utilized. When new applications of the material, or modifica-
stabilizer or processing aid during fabrication of the fabricated
tion to the material or physical forms of the materials are being
form shall be met by certification of the fabricator.
contemplated, the recommendations of Practice F 748 should
7.2.2 Determine the amount of extraneous matter by the
be considered and testing considered as described in Practices
following procedure.
F 619, F 749, F 756, F 763, F 813, and F 981 as well as Test
7.2.2.1 Prepare a number of test specimens from the fabri-
Method F 895.
cated form as agreed upon by the purchaser and seller.
9. Keywords
7.2.2.2 Visually examine (20/20 corrected vision if neces-
sary) a total area of 3200 cm taken from locations within the 9.1 fabricated forms; powdered form; ultra-high molecular
fabricated form agreed upon by the purchaser and seller. weight polyethylene
ANNEXES
(Mandatory Information)
A1. IMPACT STRENGTH
A1.1 General Description A1.3.3 Each specimen shall be free of twist and shall be
bounded by mutually perpendicular pairs of plane parallel
A1.1.1 This test method covers the determination of the
surfaces, free from scratches, pits, and sink marks.
impact resistance of Ultra-High Molecular Weight Polyethyl-
ene (UHMWPE) which is extremely impact resistant. When
A1.4 Notching of Specimens
tested according to Test Method D 256, Method A, UHMWPE
generally gives the NBF type for failure, rendering the test A1.4.1 Notching shall be done on the sides parallel to the
result invalid. This test method specifies the same type of
direction of application of molding pressure; if applicable.
pendulum impact test machine as given in Test Method D 256
A1.4.2 A 4.576 0.076 mm (0.180 6 0.003 in.) deep notch
but introduces a much higher degree of stress concentration
shall be made with a suitable machine by pressing in a 0.25
into the specimen by double notching with a razor blade. It is
mm (0.010 in.) thick single edge razor blade with a 15°
advised that the user be familiar with Test Method D 256
included angle at the cutting edge. The notching speed shall be
before attempting to use this test method.
less than 508 mm/min. (20 in./min.). A new blade shall be used
after notching 40 specimens.
A1.2 Apparatus
A1.4.3 The calibration of the notching machine shall be
checked by direct measurement of the notch depth, perpen-
A1.2.1 The Izod type impact machine which conforms to
dicularity, and offset of the two notches. One of the possible
the requirements of Test Method D 256, including the calibra-
measurement methods is given in A1.8.
tion and checking methods, shall be used.
A1.3 Test Specimen A1.5 Conditioning
A1.5.1 Conditioning—Condition the notched specimens at
A1.3.1 The geometry and dimensions of the specimen are
given in Fig. A1.1. 23 6 2°C(73 6 4 °F) for not less than 16 h prior to test.
A1.3.2 The specimens shall be made from the fabricated A1.5.2 Test Conditions—Conduct the test in the standard
form. laboratory atmosphere of 23 6 2°C(73 6 4 °F).
...