Designation: F543 − 13´1

Standard Specification and Test Methods for

Metallic Medical Bone Screws1
This standard is issued under the fixed designation F543; 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 (´) indicates an editorial change since the last revision or reapproval.

ε1 NOTE—Annex A6 was corrected editorially and portions of the standard were reformatted in December 2013.

1. Scope using all of the described methods. Instead, the user should
1.1 This specification provides requirements for materials, only select test methods that are appropriate for a particular
finish and marking, care and handling, and the acceptable device design. In most instances, only a subset of the herein
dimensions and tolerances for metallic bone screws that are described test methods will be required.
implanted into bone. The dimensions and tolerances in this 1.6 This standard may involve the use of hazardous
specification are applicable only to metallic bone screws materials, operations, and equipment. This standard does not
described in this specification. purport to address all of the safety concerns, if any, associated
with its use. It is the responsibility of the user of this standard
1.2 This specification provides performance considerations
to establish appropriate safety and health practices and
and standard test methods for measuring mechanical properties
determine the applicability of regulatory limitations prior to
in torsion of metallic bone screws that are implanted into bone.
use.
These test methods may also be applicable to other screws
besides those whose dimensions and tolerances are specified 2. Referenced Documents
here. The following annexes are included:
1.2.1 Annex A1—Test Method for Determining the Tor- 2.1 ASTM Standards:2
sional Properties of Metallic Bone Screws. E4 Practices for Force Verification of Testing Machines
1.2.2 Annex A2—Test Method for Driving Torque of Medi- E6 Terminology Relating to Methods of Mechanical Testing
cal Bone Screws. E8 Test Methods for Tension Testing of Metallic Materials
1.2.3 Annex A3—Test Method for Determining the Axial E122 Practice for Calculating Sample Size to Estimate, With
Pullout Strength of Medical Bone Screws. Specified Precision, the Average for a Characteristic of a
1.2.4 Annex A4—Test Method for Determining the Self- Lot or Process
Tapping Performance of Self-Tapping Medical Bone Screws. F67 Specification for Unalloyed Titanium, for Surgical Im-
1.2.5 Annex A5—Specifications for Type HA and Type HB plant Applications (UNS R50250, UNS R50400, UNS
Metallic Bone Screws. R50550, UNS R50700)
1.2.6 Annex A6—Specifications for Type HC and Type HD F86 Practice for Surface Preparation and Marking of Metal-
Metallic Bone Screws. lic Surgical Implants
1.2.7 Annex A7—Specifications for Metallic Bone Screw F116 Specification for Medical Screwdriver Bits
Drive Connections. F136 Specification for Wrought Titanium-6Aluminum-
4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical
1.3 This specification is based, in part, upon ISO 5835, ISO Implant Applications (UNS R56401)
6475, and ISO 9268. F138 Specification for Wrought 18Chromium-14Nickel-
1.4 The values stated in SI units are to be regarded as 2.5Molybdenum Stainless Steel Bar and Wire for Surgical
standard. No other units of measurement are included in this Implants (UNS S31673)
standard. F565 Practice for Care and Handling of Orthopedic Implants
1.5 Multiple test methods are included in this standard. and Instruments
However, it must be noted that the user is not obligated to test F620 Specification for Titanium Alloy Forgings for Surgical
Implants in the Alpha Plus Beta Condition
F799 Specification for Cobalt-28Chromium-6Molybdenum
1
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
2
Subcommittee F04.21 on Osteosynthesis. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved May 1, 2013. Published June 2013. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1977. Last previous edition approved in 2009 as F543 – 07ε1. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F0543-13E01. the ASTM website.

Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States

1
 F543 − 13´1
Alloy Forgings for Surgical Implants (UNS R31537,
R31538, R31539)
F983 Practice for Permanent Marking of Orthopaedic Im-
plant Components
F1295 Specification for Wrought Titanium-6Aluminum-
7Niobium Alloy for Surgical Implant Applications (UNS
R56700)
F1314 Specification for Wrought Nitrogen Strengthened 22
Chromium–13 Nickel–5 Manganese–2.5 Molybdenum
Stainless Steel Alloy Bar and Wire for Surgical Implants
(UNS S20910)
F1472 Specification for Wrought Titanium-6Aluminum-
4Vanadium Alloy for Surgical Implant Applications (UNS FIG. 1 Schematic of Screw Terms
R56400)
F1537 Specification for Wrought Cobalt-28Chromium-
6Molybdenum Alloys for Surgical Implants (UNS 3.1.2 breaking angle—angle of rotation when the screw fails
R31537, UNS R31538, and UNS R31539) in torsion as demonstrated by a rapid decrease in the indicated
F1586 Specification for Wrought Nitrogen Strengthened torque.
21Chromium—10Nickel—3Manganese— 3.1.3 buttress thread—an asymmetrical thread profile char-
2.5Molybdenum Stainless Steel Alloy Bar for Surgical acterized by a pressure flank which is nearly perpendicular to
Implants (UNS S31675) the screw axis.
F1713 Specification for Wrought Titanium-13Niobium- 3.1.4 cancellous screw—a screw designed primarily to gain
13Zirconium Alloy for Surgical Implant Applications purchase into cancellous bone. Cancellous screws typically
(UNS R58130) have an HB (see 4.1.2) thread and may or may not be fully
F1813 Specification for Wrought Titanium-12Molybdenum- threaded.
6Zirconium-2Iron Alloy for Surgical Implant (UNS
3.1.5 cortical screw—a screw designed primarily to gain
R58120)
biocortical purchase into cortical bone. Cortical screws typi-
F1839 Specification for Rigid Polyurethane Foam for Use as
cally have a HA (see 4.1.1) thread and are fully threaded.
a Standard Material for Testing Orthopaedic Devices and
Instruments 3.1.6 core diameter—the smallest diameter of the threaded
F2066 Specification for Wrought Titanium-15 Molybdenum portion of the screw measured at the thread root. This is also
Alloy for Surgical Implant Applications (UNS R58150) known as the minor diameter or root diameter.
2.2 ISO Standards:3 3.1.7 gage length—the distance between the holding device
5835 Implants for Surgery—Metal Bone Screws with Hex- (for example, a split collet) and the underside of the screw
agonal Driver Connection, Spherical Under Surface of head.
Head, Asymmetrical Thread—Dimensions 3.1.8 grip length—the length of threads held fast in the split
6475 Implants for Surgery—Metal Bone Screws with Asym- collet or other holding mechanism.
metrical Thread and Spherical Under-Surface— 3.1.9 insertion depth—the threaded length as inserted into
Mechanical Requirements and Test Methods the test block.
8319-1 Orthopaedic Instruments—Drive connections—Part
1: Keys for use with hexagon socket heads 3.1.10 insertion torque—the amount of torque required to
8319-2 Orthopaedic Instruments—Drive connections—Part overcome the frictional force between the screw and the
2: Screwdrivers for single slot head screws, screws with material used for testing while driving the screw into the
cruciate and cross-ecessed head screws material.
9268 Implants for Surgery—Metal Bone Screws with Coni- 3.1.11 maximum torque (N-m)—the largest value of torque
cal Under-Surface of Head—Dimensions recorded during the period of rotation before screw failure in
10664 Hexalobular Internal Driving Feature for Bolts and torsional shear when tested in accordance with Annex A1.
Screws 3.1.12 nontapping screw—a screw that has a tip that does
not contain a flute. Nontapping screws usually require a tap to
3. Terminology be inserted into the pilot hole before the insertion of the screw,
3.1 Definitions—Some of the terms defined in this section when used in moderate or hard bone.
are shown in Fig. 1. 3.1.13 partially threaded screw—a screw whose threaded
3.1.1 axial pullout strength—the tensile force required to portion does not extend fully from the screw point to the screw
fail or remove a bone screw from a material into which the head but instead has a smooth shaft running between the head
screw has been inserted. and threads.
3.1.14 pilot hole—the hole drilled into the bone into which
3
Available from American National Standards Institute, 25 W. 43rd St., 4th the screw tip is inserted. The pilot hole is normally slightly
Floor, New York, NY 10036. larger than the screw’s core diameter. However, if the screw is

2
 F543 − 13´1
to be used to provide compression across a fracture, a portion 5. Material
of the pilot hole may be larger to allow for a clearance fit. 5.1 Screws shall be fabricated from a metallic material
3.1.15 pitch—the length between the thread crests. intended for surgical implant applications, and having ASTM
medical material. In addition, the materials shall be biocom-
3.1.16 removal torque—the amount of torque required to
patible for the intended application.
overcome the frictional force between the screw and the
material used for testing while removing the screw from the 6. Dimensions and Tolerances
material (for example, counterclockwise rotation for right-hand
thread). 6.1 There are many types of metallic bone screw designs
available, so a complete list of dimensions and tolerances for
3.1.17 screw head—the end of the screw which is opposite all screws covered by this specification is unfeasible. However,
of the tip and from which the means of inserting the screw is this specification does provide required dimensions and toler-
coupled. ances for four types of screws as classified in 4.1. Screws
3.1.18 screw length—the overall length of the screw mea- conforming to this specification, and designated HA, HB, HC,
sured from the screw head to the screw tip. or HD screws, shall be fabricated in accordance with the
dimensions and tolerances described in Annex A5 and Annex
3.1.19 screw thread—a helical groove on a cylindrical or A6, respectively.
conical surface. The projecting helical ridge thus formed is
called a screw thread, consisting of peaks (crests) and valleys 7. Finish and Marking
(roots). 7.1 The screw shall be free from nicks, dents, burrs, and
3.1.20 self-tapping force (N)—the amount of axial force scratches when examined in accordance with Practice F86.
required to engage the self-tapping features of self-tapping 7.2 When size permits, the following information should be
style screws when tested in accordance with Annex A4. legibly marked on the head of the screw (in order of prefer-
3.1.21 self-tapping screw—a screw that has any number of ence):
flutes at its tip which are intended to cut the screw’s thread 7.2.1 Manufacturer’s name or logo,
form into the bone upon insertion. 7.2.2 Screw Size—If a screw is manufactured in accordance
with ASTM or ISO specifications, the ASTM or ISO designa-
3.1.22 size—an identification of a screw based on its nomi-
tion should be provided,
nal thread diameter, as defined in Section 6.
7.2.3 Material,
3.1.23 solid core—a screw that does not contain a cannula- 7.2.4 Catalog number, and
tion along its longitudinal axis. 7.2.5 Manufacturing lot number.
3.1.24 thread diameter—the largest diameter of the threaded 7.3 Screws shall be marked in accordance with Practice
portion of the screw measured over the thread crests. This is F983, unless otherwise specified in 7.2, in a manner such that
also known as the major diameter. the mechanical integrity of the screw is not compromised.
3.1.25 thread length—the length of the threaded portion of 8. Care and Handling
the screw, measured from the thread runout to the screw tip.
8.1 Screws should be cared for and handled in accordance
3.1.26 thread runout—the intersection of the screw thread with Practice F565, as appropriate.
with either the screw shaft or screw head.
9. Driving Instruments
3.1.27 torsional yield strength (N-m)—the point at which
the screw reaches its proportional limit when tested in accor- 9.1 A variety of screwdrivers exist for the insertion and
dance with Annex A1. This will be determined by the offset removal of bone screws. The classification and dimensions for
method. A 2° offset value shall be used. various screw-drive recesses currently used in the medical
industry are documented in Annex A7. Specification F116
4. Classification provides related dimensional information for several types of
medical screwdrivers.
4.1 There are a large variety of medical bone screws
currently in use. They may be classified by the definitions 9.2 Screws conforming to this specification, and designated
provided in Section 3. This specification currently includes HA, HB, HC, or HD screws, shall be manufactured with drive
information that defines the following types of screws: recesses that conform to the requirements specified in Annex
A5 and Annex A6, respectively.
4.1.1 Type HA—Spherical undersurface of head, shallow,
asymmetrical buttress thread, and deep screw head. 10. Performance Considerations and Test Methods
4.1.2 Type HB—Spherical undersurface of head, deep, 10.1 The following properties may be important when
asymmetrical buttress thread, and shallow screw head. determining the suitability of a screw for a particular applica-
4.1.3 Type HC—Conical undersurface of head, symmetrical tion. However, the test methods referenced as follows may not
thread. be appropriate for all types of implant applications. The user is
4.1.4 Type HD—Conical undersurface of head, asymmetri- cautioned to consider the appropriateness of the test methods in
cal thread. view of the devices being tested and their potential application.

3
 F543 − 13´1
10.1.1 Torsional Strength—This test method is an important 10.1.5 Removal Torque—This test method may be an im-
parameter to prevent screw breakage during insertion or portant parameter to avoid failure of the screw during removal
removal. The torsional strength shall be determined using the and to ensure that the screw may be easily removed by the
test methods described in Annex A1. surgeon. The removal torque should be much less than tor-
10.1.2 Breaking Angle—This test method provides a mea- sional yield strength of the screw and of the appropriate
sure of the ductility of the screw when undergoing a torsional screwdriver bit. The removal torque may be determined using
moment. A screw with a greater breaking angle may provide an the test methods described in Annex A2.
earlier tactile warning to the surgeon that the screw is reaching
10.1.6 Self-Tapping Force—This test method may be an
its maximum torsional strength. The breaking angle shall be
determined using the test methods described in Annex A1. important parameter to ensure that the screw may be easily
10.1.3 Axial Pullout Strength—This test method may be an inserted by the surgeon, particularly if the screw is fixed in
important parameter if the screw is subjected to axial tensile poor quality or osteoporotic bone. The self-tapping force may
forces, or if the screw is fixed into poor quality or osteoporotic be determined using the test method described in Annex A4.
bone. The pullout strength may be determined using the test
methods described in Annex A3. 11. Performance Requirements
10.1.4 Insertion Torque—This test method may be an im- 11.1 Screws shall meet the mechanical performance require-
portant parameter to avoid failure of the screw during insertion
ments specified in its associated specification annex.
and to ensure that the screw may be easily inserted by the
surgeon. The insertion torque should be much less than
12. Keywords
torsional yield strength of the screw and of the appropriate
screwdriver bit. The insertion torque may be determined using 12.1 bone screw; dimensions; insertion; performance re-
the test methods described in Annex A2. quirements; pullout; static; test methods; torsion

ANNEXES

(Mandatory Information)

A1. TEST METHOD FOR DETERMINING THE TORSIONAL PROPERTIES OF METALLIC BONE SCREWS

A1.1. Significance and Use

A1.1.1 This test method is used to measure the torsional

yield strength, maximum torque, and breaking angle of the
bone screw under standard conditions. The results obtained in
this test method are not intended to predict the torque encoun-
tered while inserting or removing a bone screw in human or
animal bone. This test method is intended only to measure the
uniformity of the product tested or to compare the mechanical
properties of different, yet similarly sized, products.

A1.2. Apparatus
A1.2.1 Testing Fixture—The torsion testing apparatus that is
to be used for applying the required torque to the specimen
shall be calibrated for the range of torques and rotational
displacements used in the determination.4 A suitable testing
fixture for the torsional yield strength-maximum torque-
breaking angle test is illustrated in Fig. A1.1.
A1.2.1.1 Test Speed—The torsional force shall be applied at FIG. A1.1 Test Apparatus for Determination of Torsional Breaking
a constant rate of 1 to 5 r/min. Force and Breaking Angle
A1.2.1.2 Torque Transducer—A transducer to translate the
applied torque into an electrical signal amenable to continuous
recording, calibrated over the range of torques, both in the
clockwise and counterclockwise rotation, to be encountered in
the test method, shall be provided.
4
A1.2.1.3 Torsional Displacement Transducer—A transducer
At the time that this specification was approved, no standard test method for the
verification of torsion machines or transducers has been accepted. The user is urged to translate the angle of twist into an electrical signal amenable
to review Terminology E6 and Test Methods E8 for general guidance. to continuous recording, calibrated over the range of angles to

4
 F543 − 13´1
be encountered in the test and an accuracy of 60.3°, both in the breaking angle. A second chart recorder with an angular displacement
clockwise and counterclockwise rotation, shall be provided. scale or sensitivity of 10°/cm or less is suggested to provide accurate offset
measurement capability for measuring a 2° angular displacement.
A1.2.1.4 Specimen Holder—A mechanical device to clamp Alternatively, one chart recorder and a digital storage oscilloscope may be
onto the bone screw to prevent its rotation while being stressed used.
without significantly damaging its mechanical integrity shall be
A1.3.3 The torsional yield strength will be determined by
provided. One such method is to insert a threaded stopper into
the offset method (Fig. A1.2), using the torque versus angle of
the opposite side of a test block. The test block for this holding
rotation curve produced in A1.3.1 and A1.3.2.
mechanism will accommodate the insertion of a threaded
A1.3.3.1 On the torque versus angle of rotation curve, locate
stopper on the other side of the test block. The threaded stopper
Point m equal to a rotation of 2°. Draw mn parallel to OA, and
will prevent the screw from being completely inserted into the
locate b, the intersection of mn with the torque versus angle of
test block and will allow the torsional strength of the screw to
rotation curve. Torque B is defined as the torsional yield
be measured. This holder will be modified according to the size
strength.
of the testing specimen so that the gage length of the specimen
A1.3.3.2 The maximum torque is determined by the largest
will be as outlined in A1.3.1.
value of torque on the torque versus angle of rotation curve.
A1.2.1.5 Recorder—The data recorder shall be suitable to
A1.3.3.3 The breaking angle is determined from the torque
continuously record torque versus angle of rotation, calibrated
versus angle plot shown in Fig. A1.3. The breaking angle is
in units of Newton-metres for torque and degrees for angle of
defined as the point at which the torque portion of the curve
rotation. The value of torque shall have a resolution of 5 % of
demonstrates its most rapid descent (negative slope) to total
torsional yield strength. The angular displacement scale shall
failure. The breaking angle (B.A.) is determined as the inter-
have a minimum sensitivity so as to enable an accurate offset
section of the two tangents (D and E) shown in Fig. A1.3. Line
measurement capability for a 2° angular displacement (see
E is a tangent to the horizontal portion of the curve which
A1.3.3).
represents maximum torque. Line D is drawn at the curve’s
A1.2.2 Test Specimen—The test specimen shall be a com- most rapid descent. The intersection of these two lines is the
pletely fabricated and finished bone screw. breaking angle (B.A.) and is recorded to the nearest 10°.

A1.3. Procedure A1.4. Report

A1.3.1 Torsional Yield Strength, Maximum Torque, and A1.4.1 Report the following information for each specimen
Breaking Angle—Place the specimen in the holding device so tested:
that five threads, below the head of the screw, are exposed A1.4.1.1 Screw Identification—Reference any applicable
outside the holding device (for example, split collet, and so ASTM or ISO specification that may apply to the specimen. If
forth). If the test specimen cannot accommodate this setup specifications do not exist, provide head form, thread form,
because the screw is too small or is partially threaded, alternate major and minor diameter, thread pitch, overall screw length,
procedures may be used. For fully threaded screws that are too head and shank (unthreaded portion of the screw excluding the
small, the gage length of the specimen should represent 20 % head) length, and type of screw point.
of the threaded portion of the test specimen. For partially A1.4.1.2 Screw chemical composition.
threaded screws, a large enough portion of the screw thread A1.4.1.3 Surface finish.
should be gripped to firmly secure the screw so that it does not A1.4.1.4 Gage length.
rotate when under torsional load. There are no specific require-
ments on the gage length or the grip length in this case;
however, at least one full thread shall be exposed, if possible.
Since the gage length and grip length can vary for these screws,
the only requirement is that both be reported.
A1.3.2 The gage length or grip length should be kept the
same length for test screws of similar design. If a split collet
and collet holder are used, the following test method is
appropriate. Place the split collet in the collet holder. Clamp the
split collet and holder in the vise. The clamping force of the
vise should be sufficient to prevent rotation of the screw or the
split collet. Drive the specimen in the direction of insertion,
using an appropriate size and configured screwdriver bit, by
applying a torsional force. If an axial load is required to
maintain the screwdriver bit in the screw head, its value should
be noted. The torque wrench shall be driven at a rate of 1 to 5
revolutions/min (r/min).
NOTE A1.1—The simultaneous use of two chart recorders may simplify
the ability to measure torsional yield strength accurately by the offset
method. One chart recorder with an angular displacement scale or
sensitivity of 50°/cm is convenient for measuring maximum torque and FIG. A1.2 Typical Torque Versus Angle of Rotation Curve

5
 F543 − 13´1
A1.4.1.6 Maximum torque.
A1.4.1.7 Breaking angle.
A1.4.1.8 Torque versus angle of rotation plot.
A1.4.1.9 The size of the exposed portion of the screwdriver
(that is, the length and diameter relative to the tested screw) or
the angular deformation of the screwdriver assembly at maxi-
mum torque.
A1.4.1.10 Grip Length—Does not have to be reported for a
fully threaded screw of ASTM or ISO specification whose
overall length is given.
A1.4.1.11 Fracture Location—The location can be specified
by listing the number of threads below the head at which the
screw fails or by measuring the distance below the head to the
approximate fracture point.
FIG. A1.3 Typical Plot of Torque Versus Torsion Angle A1.5. Precision and Bias
A1.5.1 Data establishing the precision and bias to be ex-
A1.4.1.5 Torsional yield strength. pected from this test method have not yet been obtained.

A2. TEST METHOD FOR DRIVING TORQUE OF MEDICAL BONE SCREWS

A2.1. Significance and Use

A2.1.1 This test method is used to measure the torque bushing, and bushing support depicted. It shall be sufficiently
required to drive a bone screw into a standard material. The rigid to not deflect or deform under the conditions of loading
results obtained in this test method bear no direct correlation to encountered during the test.
the insertion torque required to insert the subject bone screw in A2.2.1.1 Torque Transducer—A transducer to translate the
human or animal bone. This test method is used only for the applied torque into an electrical signal amenable to continuous
purpose of maintaining the uniformity of the product tested. recording, calibrated over the range of torques, both in the
clockwise and counterclockwise rotation, to be encountered in
A2.2. Apparatus the test shall be provided.
A2.2.1 Testing Fixture—A suitable test fixture as shown in A2.2.1.2 Torsional Displacement Transducer—A transducer
Fig. A2.1 may be used for the insertion-removal torque tests.4 to translate the angle of twist into an electrical signal amenable
This fixture shall incorporate the test block material that to continuous recording, calibrated in a manner similar to
conforms to Specification F1839, test block clamp, drill Practices E4 over the range of angles to be encountered in the

FIG. A2.1 Schematic of Test Apparatus for Driving Force

6
 F543 − 13´1
test to an accuracy of 60.3°, both in the clockwise and the screw. When the test block is inserted into the test fixture
counterclockwise rotation, shall be provided. (Fig. A2.1), the pilot hole, screw, and screwdriver shall be on
A2.2.1.3 Data Recorder—The data recorder shall be suit- the same axis.
able to record torque versus angle of rotation continuously,
calibrated in units of newton-metres for torque and degrees for A2.3. Sampling
angle of rotation. The value of torque shall have a resolution of A2.3.1 Representative random samples may be taken from
10 % of the maximum measured torque. The angular displace- each lot or processing quantity in accordance with Practice
ment scale shall have sensitivity such that at least four E122.
revolutions can be recorded and displayed.
A2.4. Procedure
A2.2.1.4 Bushing—A suitable replaceable bushing, fabri-
cated from material that conforms to Specification F1839, shall A2.4.1 Insertion and Removal Torque—Place the specimen
be incorporated into the testing fixture. This bushing shall be of in the test fixture as illustrated in Fig. A2.1. Drive the specimen
sufficient length and rigidity to ensure that specimens are into the test block, using the appropriate size and configured
driven into the test block normal to the top surface of the test screwdriver bit, by applying a torsional force at a rate of 1 to
block. The bore of the bushing shall be of such dimension as to 5 r/min, to the head of the specimen with the motor-driven
ensure guidance of the test specimen with minimum frictional torque wrench. The insertion torque shall be the maximum
resistance between the major diameter of the test specimen and reading recorded during the initial four revolutions of the
the bore of the bushing. Worn bushings shall be discarded and specimen. The removal torque shall be measured by reversing
replaced with new bushings before conducting the test. the direction of rotation and recording the maximum torque
recorded during the four revolutions required to remove the
A2.2.1.5 Test Block Clamp—A clamp or holding device screw from the test block. Values should be reported in
shall be incorporated into the testing fixture. This holding n\Newton-metres. A 1.14-kgf or less axial load should be used
device shall maintain the drilled pilot hole in the test block in to maintain the screwdriver bit in the screw head during both
line with the test specimen. The holding device shall not the insertion and removal procedures. If a larger axial load is
deform the test block during clamping of the test block or applied, this load shall be recorded on the report form. This
performance of the test. load may be measured by any appropriate method.
A2.2.1.6 Test Specimen—The test specimen shall be a
completely fabricated, finished, and sterilized bone screw of A2.5. Report
sufficient length to transverse the bushing and test block. A2.5.1 The report shall include the following for each
A2.2.1.7 Test Block—The test block shall be fabricated from specimen tested. (All standards units for reporting shall be in
a uniform material that conforms to Specification F1839. The SI units.)
choice of appropriate foam density for this test is at the A2.5.1.1 Screw Identification—Reference any applicable
discretion of the user. See Section 8.6.2 of F1839 for additional ASTM or ISO standard specification that may apply to the
information. To accommodate the requirements of the pilot specimen. If specifications do not exist, provide head form,
hole as described in A2.2.1.8, the smallest dimension of the test thread form, major and minor diameter, thread pitch, overall
block’s surface shall be greater than 10× the diameter of the screw length, head and shank (unthreaded portion of the screw
screw under test. The top and bottom surfaces shall be flat, excluding the head) length, and type of screw point.
smooth, and parallel (within 60.4 mm) as required to ensure A2.5.1.2 Screw chemical composition.
that the test block will be supported in the fixture with the top A2.5.1.3 Surface finish.
surface at an angle of 90° to the centerline of the test specimen. A2.5.1.4 Insertion torque.
The edges of the test block shall be of such contour or A2.5.1.4.1 Axial load required.
squareness as required to ensure that the test block clamp shall A2.5.1.4.2 Insertion depth (may be calculated or measured).
A2.5.1.4.3 Specification of whether the pilot holes were or
hold the test block free of relative motion without deformation
were not pretapped, if so, specifications of the tap size, tap
of the test block during clamping or testing. The test block
diameter, and tap depth shall be reported.
thickness shall be not less than 4.8 mm.
A2.5.1.4.4 Insertion test speed if outside the range specified
A2.2.1.8 Pilot Holes in Test Block—Pilot holes shall be in A2.4.1.
drilled in the test block for insertion and removal of the test A2.5.1.5 Removal torque.
specimen. The drill size used shall be that specified by the A2.5.1.5.1 Axial load required.
screw manufacturer, for the size screw being tested. If specified A2.5.1.5.2 Insertion test speed if outside the range specified
by the screw manufacturer, the specified sized tap shall be used in A2.4.1.
to tap the pilot hole before testing. The holes shall be drilled at A2.5.1.6 Test Block Material Description—Specification
90° to the top surface of the test block. The holes shall be F1839 grade. For bushing material that does not conform to
drilled straight and true, free of taper, bell mouth, or barrel Specification F1839, provide
shape. If there are multiple holes in one test block, the pilot A2.5.1.6.1 Trade name.
holes shall be spaced sufficiently far away from test block A2.5.1.6.2 Composition.
edges so that testing does not deform the test block edges. A2.5.1.6.3 Density.
Spacing should have a minimum distance of 5× the diameter of A2.5.1.6.4 Tensile strength.

7
 F543 − 13´1
A2.5.1.6.5 Compression strength.
A2.5.1.6.6 Shear strength.
A2.6. Precision and Bias
A2.6.1 Data establishing the precision and accuracy to be
expected from this test method have not yet been obtained.

A3. TEST METHOD FOR DETERMINING THE AXIAL PULLOUT STRENGTH OF MEDICAL BONE SCREWS

A3.1. Significance and Use

A3.1.1 This test method is used to measure the axial tensile loading conditions is negligible. The test block clamp should
force required to fail or remove a bone screw from a defined have a minimum grip span of five times the major diameter of
material. The results obtained in this test method are not the bone screw with the screw centered between the grips. The
intended to predict the force required to remove the subject grip span should be consistent throughout testing.
bone screw from human or animal bone. This test method is A3.2.2 Test Block—The test block shall be fabricated from a
intended only to measure the uniformity of the products tested uniform material that conforms to Specification F1839. The
or to compare the strength of different products. choice of appropriate foam density for this test is at the
A3.1.2 This test method may not be appropriate for all types discretion of the user. See Section 8.6.2 of F1839 for additional
of implant applications. The user is cautioned to consider the information. The top and bottom surfaces shall be flat, smooth,
appropriateness of the method in view of the materials being and parallel (within 60.4 mm) as required to ensure that the
tested and their potential application. test block will be supported in the fixture with the top surface
at an angle of 90° to the centerline of the test specimen. The
A3.2. Apparatus edges of the test block shall be of such contour or squareness
A3.2.1 Test Fixture—Machines used for testing the axial as required to ensure that the test block clamp shall hold the
pullout strength of screws shall conform to the requirements of test block free of relative motion without deformation of the
Practices E4. A suitable test fixture as shown in Fig. A3.1 may test block during clamping or testing. The test block thickness
be used for testing. This fixture shall incorporate the test block shall be not less than 20 mm.
material which conforms to Specification F1839, test block A3.2.3 Data Acquisition Device—The data recorder shall be
clamp, drill bushing, and bushing support depicted in the suitable to continuously record load versus load fixture dis-
insertion torque test method, Annex A2. In addition to these placement.
requirements, the test block clamp and bushing support should
A3.2.4 Load Frame—Machines used for testing shall con-
be sufficiently rigid such that deflection under the required
form to the requirements of Practices E4. The loads used for
the test method shall be within the loading range of the test
machine as defined in Practices E4.
A3.2.5 Load Fixture—A suitable fixture shall be used to
place a tensile load on the bone screw. The load shall be
transferred through the head of the screw and should be aligned
with the screw’s longitudinal axis. The fixture shall have a slot
to capture the head of the screw without contact being made
with the screw’s shaft. To ensure proper alignment, the slot
shall have a spherical recess into which the screw head can be
seated directly under the applied load.
A3.3. Sampling, Test Specimens, and Test Units
A3.3.1 All test components shall be representative of im-
plant quality products.
A3.4. Procedure
A3.4.1 Insertion of the Test Specimen—The bone screws
shall be inserted into the standard material in accordance with
the insertion torque test method, Annex A2. The screws shall
be inserted at a rate of 3 r/min to a depth of 20 mm. For fully
FIG. A3.1 Schematic of Test Apparatus for Pullout Strength threaded screws with threaded lengths less than 20 mm, the

8
 F543 − 13´1
insertion depth should be 60 % of the threaded length of the specimen. If specifications do not exist, provide head form,
screw. Partially threaded bone screws should have all threads thread form, helix angle, major and minor diameter, thread
inserted into the standard material. pitch, overall screw length, head and shank length, length of
A3.4.2 Axial Pullout Strength of the Test Specimen—The threaded portion of shank for partially threaded screws, and
test block and test block clamp depicted in Annex A2 shall be type of screw point.
fixed to the base of the load frame so that the longitudinal axis A3.6.1.2 Screw chemical composition.
of the screw is aligned with the direction of the applied load. A3.6.1.3 Surface finish.
The screw’s head shall be placed in the slot of the load fixture A3.6.1.4 Axial pullout strength (as defined in 3.1.1).
and seated in the spherical recess. The load fixture shall then be A3.6.1.5 Grip span.
attached to the load frame. A tensile load shall be applied to the A3.6.1.6 Insertion depth.
test specimen at a rate of 5 mm/min until the screw fails or A3.6.1.7 Test block thickness.
releases from the test block. Load (newtons) versus load fixture A3.6.1.8 Mode of failure.
displacement (millimetres) shall be recorded on a data acqui- A3.6.1.9 Test Block Material Description—Specification
sition device, noting the maximum load applied and the mode F1839 grade or density. For materials that do not conform to
of failure (screw shaft, screw threads, or material failure). F1839, provide the following information and the appropriate
test methods used to determine the properties of the test block
A3.5. Calculation or Interpretation of Results material:
A3.6.1.9.1 Trade name,
A3.5.1 Axial Pullout Strength—Determine the axial pullout A3.6.1.9.2 Composition,
strength (in Newtons) of the test specimen from the load- A3.6.1.9.3 Density,
displacement curve. The maximum load is reached during the A3.6.1.9.4 Tensile strength,
test method. A3.6.1.9.5 Compression strength, and
A3.6.1.9.6 Shear strength.
A3.6. Report
A3.6.1 Report the following information: A3.7. Precision and Bias
A3.6.1.1 Screw Identification—Reference any applicable A3.7.1 Data establishing the precision and accuracy to be
ASTM or ISO standard specification that may apply to the expected from this test method have not yet been obtained.

A4. TEST METHOD FOR DETERMINING THE SELF-TAPPING PERFORMANCE OF SELF-TAPPING MEDICAL BONE
SCREWS

A4.1 Significance and Use

A4.1.1 This test method is used to determine the axial

compression load (force) required to engage the self-tapping
feature of self-tapping medical bone screws into a standard
material. The results obtained in this test method bear no direct
correlation to the axial force required to insert the subject bone
screw in human or animal bone. This test method is used only
to measure uniformity of the product tested or to compare the
performance of different, yet similarly sized, products. This test
method is not applicable to “self-drilling” or “self-drilling/self-
tapping” styles of medical bone screws.

A4.2 Apparatus
A4.2.1 Testing Apparatus—A schematic for the axial self-
tapping force test apparatus is illustrated in Fig. A4.1. The
apparatus shall provide a variable speed motor capable of
continuously driving a spindle. The spindle shall be capable of
a continuous rotation as well as axial translation to allow
variable force on the test specimen. The apparatus and spindle
shall be sufficiently rigid to neither deflect nor deform under FIG. A4.1 Schematic of Test Apparatus for Determination of Self-
the conditions of loading encountered during the test. The Tapping Force
apparatus shall incorporate a test block clamp for purpose of
rigidly fixing a test block. The apparatus shall be capable of

9
 F543 − 13´1
continuously monitoring and recording the force, torque, and edges. Spacing should have a minimum distance as recom-
axial displacement of the specimen. The apparatus shall be mended in A2.2.1.8. When the test block is inserted into the
calibrated for the range of forces, torques, and linear displace- test fixture (Fig. A4.1), the pilot hole, screw, and screwdriver
ments used in the determination. shall be on the same axis.
A4.2.2 Compression Load Cell—A transducer to translate A4.2.8 Test Specimen—The test specimen shall be a com-
the applied axial force into an electrical signal suitable for pletely fabricated and finished bone screw of sufficient length
continuous recording and calibrated over the range of forces to to allow completion of the test.
be encountered in the test method, shall be provided. The load A4.2.9 Recorder—The data recorder shall be suitable to
cell should have an accuracy of 0.5 % of full-scale output and record continuously, at a minimum rate of 10 Hz, axial
allow measurement resolution of 61.0 N. compression force, torque, and axial spindle displacement. The
A4.2.3 Torque Transducer—A transducer to translate the recorder shall be capable of recording two Y axes simultane-
applied torque into an electrical signal suitable for continuous ously (force and torque to Y Axis 1 and displacement to Y Axis
recording and calibrated over the range of torques, both in 2) versus time (X axis), calibrated in units of Newtons for
clockwise and counterclockwise rotation, to be encountered in force, Newton-metres for torque, and millimetres for displace-
the test method, shall be provided. The torque transducer ment. The value of force and torque should have a resolution of
should have an accuracy of 0.5 % of full-scale output and allow 0.5 % of full-scale output and sensitivity so as to enable an
measurement resolution of 60.10 N-m. accurate recording capability of a minimum of 1.0 N and 0.10
N-m, respectively. The value of torque shall have a resolution
NOTE A4.1—A combination compressive load and torque transducer is of 0.5 % of full-scale output. The linear displacement scale
suitable for this application provided the transducer meets the specifica-
tions detailed in A4.2.2 and A4.2.3.
should have a minimum sensitivity so as to enable an accurate
recording capability for 0.5 mm.
A4.2.4 Linear Displacement Transducer—A transducer to
translate the axial displacement of the test apparatus’ spindle A4.2.10 Test Speed—The torsional force shall be applied at
into an electrical signal suitable for continuous recording and a constant rate of 30 r/min. The axial compression force shall
calibrated over the range of displacements to be encountered in be applied at a constant rate of approximately 2 N/s. The
the test method, shall be provided. The displacement trans- torsional test speed has been selected to represent the clinical
ducer should have an accuracy of 1 % of full scale and allow situation of hand-driven screws. The axial load rate has been
a measurement resolution of 60.5 mm. selected to allow easy identification and reaction to the unique
self-tap events on the data output recorder. Other test speeds
A4.2.5 Test Block Clamp—A clamp or holding device shall and load rates can be used provided they are justified and
be incorporated into the testing fixture. This holding device reported. All comparative tests shall be performed at the same
shall maintain the drilled pilot hole in the test block in line with test speeds.
the test specimen. The holding device shall be sufficiently rigid
to neither deflect nor deform under the conditions of loading A4.3 Sampling
encountered during the test and yet not deform the test block A4.3.1 Representative random samples may be taken from
during clamping of the test block or performance of the test. each lot or processing quantity in accordance with Practice
A4.2.6 Test Block—The test block shall be fabricated from a E122.
uniform material that conforms to Specification F1839. The top
and bottom surfaces shall be flat, smooth, and parallel (within A4.4 Procedure
0.4 mm) as required to ensure that the test block will be A4.4.1 Self-Tapping Force—The pre-drilled test block is
supported in the fixture with the top surface at an angle of 90° rigidly fixed in the test block clamp device shown in Fig. A1.1.
to the centerline of the test specimen. The edges of the test The appropriate sized screwdriver (“driver”) is inserted into the
block shall be of such contour or squareness as required to spindle and the alignment of the pilot hole with the driver is
ensure that the test block clamp shall hold the test block free of verified. The self-tapping bone screw specimen is then pre-
relative motion without deformation of the test block during assembled (“loaded”) onto the driver. The specimen/driver
clamping or testing. The test block thickness shall be not less assembly is then lowered via the spindle into the pilot hole and
than 25 mm. the axial displacement of the spindle adjusted to achieve a
A4.2.7 Pilot Holes in Test Block—Pilot holes shall be drilled maximum preload of 1.0 N to maintain screw-to-screwdriver
in the test block for insertion and removal of the test specimen. engagement.
The drill size used shall be that specified by the screw A4.4.2 The specimen is then driven by the test apparatus at
manufacturer for the size screw being tested. The holes shall be a constant rotational rate of 30 revolutions/minute (r/min). The
drilled at 90° to the top surface of the test block. The holes axial force, torque, and displacement channels on the data
shall be drilled straight and true, free of taper, bell mouth, or recorder are monitored simultaneously while the axial force is
barrel shape. The holes should be drilled completely through increased at a rate of approximately 2.0 N/s (6 1.0 N/s). The
the test block and all particulate debris removed prior to axial compression force shall continue to be increased until the
inserting the test specimen. If there are multiple holes in one self-tapping features of the screw engage the test block as
test block, the pilot holes shall be spaced sufficiently far away indicated by a marked increase in torque and axial displace-
from test block edges so that testing does not deform test block ment are observed as shown in Fig. A4.2.

10
 F543 − 13´1
provided: (1) the secondary, maximum axial force is reported
as the “self-tap force”; (2) the specimen completes five
revolutions after the secondary self-tap; and (3) the specimen is
indicated as “stalled” or “stripped” in the Comments section of
the test report. Any specimen that stalls more than once shall be
considered invalid.
A4.5 Report
A4.5.1 Report the following information for each specimen
tested (all standard units for reporting shall be in SI units):
A4.5.1.1 Screw Identification—Reference any applicable
ASTM or ISO specification that may apply to the specimen. If
specifications do not exist, provide head form, thread form,
FIG. A4.2 Typical Test Method Output major and minor diameter, thread pitch, overall screw length,
head and shank (unthreaded portion of the screw excluding the
head) length, and type of screw point.
A4.4.3 This unique combination signifies the engagement
A4.5.1.2 Screw chemical composition.
of the self-tapping features of the bone screw into the test
A4.5.1.3 Ultimate tensile strength.
material and the onset of “self-tap.” At this moment, the
A4.5.1.4 Surface finish.
increase in axial force should be discontinued and the load
A4.5.1.5 Self-tap force.
level at which self-tap was first noted maintained (that is, “load
A4.5.1.6 Comments regarding unique testing conditions or
and hold”) while simultaneously monitoring the specimen to
specimen occurrences.
ensure the continued self-advance into the test block as noted
A4.5.1.7 Insertion test speed if outside the range specified.
by the continually increasing torque and axial displacement.
A4.5.1.8 Test Block Material Description—Specification
(Note that in some instances the axial force may decrease at the
F1839 grade. (Note that Specification F1839 is intended to
onset of self-tap, as shown in Fig. A4.2, indicating self-
simulate cancellous bone. However, self-tapping screws must
advancement of the specimen into the test block without the
penetrate cortical bone as well. Therefore, alternative materi-
need for continuous, applied force. Thus, during this phase of
al(s) may be used to challenge the test specimens provided a
the test, the axial force serves only to maintain driver-to-screw
material choice justification is included in the test report.) For
engagement.)
material that does not conform to Specification F1839, provide:
A4.4.4 A total of five complete revolutions should be (1) Trade name.
achieved after the onset of self-tap to be considered a valid (2) Composition.
specimen. The maximum axial force achieved at the onset of (3) Density.
self-tap shall be reported as the “self-tap force.” Values should (4) Tensile strength.
be reported in Newtons. On occasion, the specimen will (5) Compression strength.
self-tap and then cease advancement into the test block (“stall” (6) Shear strength.
or “strip”) within the first five revolutions, as indicated by a
rapid loss of torsional resistance and an unchanging (“flat- A4.6 Precision and Bias
lined”) axial displacement. When a specimen stalls, the re- A4.6.1 Data establishing the precision and accuracies to be
sumption of the increase in axial force at a rate of 2.0 N/s expected from this test method will be obtained within five
(61.0 N/s) is acceptable to once again achieve self-tap years.

A5. SPECIFICATIONS FOR HA AND HB METALLIC MEDICAL BONE SCREWS

A5.1 Screw Classification A5.2 Screw and Thread Form Dimensions

A5.1.1 There are a large variety of medical bone screws A5.2.1 There are many types of metallic bone screw designs
currently in use. They may be classified by the definitions available, so a complete list of dimensions and tolerances for
provided in Section 3. This specification includes the following all screws covered by this specification is unfeasible. This
types of screws with a solid head and a solid core: specification specifies dimensions and tolerances for two types
A5.1.1.1 Type HA—Shallow, asymmetrical buttress thread, of screws that are classified in 4.1. Screws conforming to this
deep screw head, and spherical undersurface of head. specification, and designated with either the HA or HB
A5.1.1.2 Type HB—Deep, asymmetrical buttress thread,
shallow screw head, and spherical undersurface of head.

11
 F543 − 13´1
classification shall be fabricated in accordance with the dimen- A5.3.1.2 Type HB—Hexagonal recess for accepting the
sions and tolerances in this Annex in accordance with the Specification F116 Type IV—Hexagonal bit.
following requirements.
A5.2.1.1 Type HA: A5.4 Performance Requirements
(1) Screw Dimensions— The dimensions of HA screws are A5.4.1 Screws that meet the dimensional requirements of
given in Table A5.1 and Fig. A5.1. the HA or HB screws in A5.2 shall also meet the following
(2) Screw Thread— The dimensions of the threads of HA mechanical performance requirements.
screws are given in Table A5.2 and Fig. A5.2. A5.4.1.1 Maximum Torque:
A5.2.1.2 Type HB: (1) A minimum of five screws for a particular type and size
(1) Screw Dimensions— The dimensions of HB screws are shall be tested in accordance with the test methods described in
given in Table A5.3 and Fig. A5.3. Annex A1, with five threads exposed in the gage length.
(2) Screw Thread— The dimensions of the threads of HB (2) The maximum torque of all screws within the sample of
screws are given in Table A5.4 and Fig. A5.4. screws from a particular type and size of screw shall meet or
exceed the requirements provided in Table A5.5.
A5.3 Drive Connections A5.4.1.2 Breaking Angle:
A5.3.1 Screws conforming to this specification, and desig- (1) A minimum of five screws for a particular type and size
nated with either the HA or HB classification shall be fabri- shall be tested in accordance with the methods described in
cated with the following drive connections in accordance with Annex A1, with five threads exposed in the gage length.
the dimensions and tolerances found in Annex A7. (2) The breaking angle of all screws within the sample of
A5.3.1.1 Type HA—Hexagonal recess for accepting the screws from a particular type and size of screw shall meet or
Specification F116 Type IV—Hexagonal bit. exceed the requirements provided in Table A5.5.

TABLE A5.1 Dimensions for HA Screws (Fig. A5.1)

Screw Type and Size Head Diameter, d2 Head Height, k Bottom Head Radius, Top Head Radius, r2 Tip Radius, r3 Screwdriver
r1 SizeA
HA 1.5 3.00 +0.00 1.6 1.750 +0.000 1.5 0.3 1.5
−0.10 −0.075
HA 2.0 4.00 +0.00 1.9 2.250 +0.000 2.0 0.4 1.5
−0.10 −0.075
HA 2.7 5.00 +0.00 2.3 2.750 +0.000 2.5 0.4 2.5
−0.15 −0.075
HA 3.5 6.00 +0.00 2.6 3.250 +0.000 2.5 1.0 2.5
−0.15 −0.075
HA 4.0 6.00 +0.00 2.4 3.250 +0.000 2.5 1.0 2.5
−0.15 −0.075
HA 4.5 8.00 +0.00 4.6 4.250 +0.000 2.5 1.0 3.5
−0.15 −0.075
HA 5.0 8.00 +0.00 4.6 4.250 +0.000 2.5 1.0 3.5
−0.15 −0.075
A
Type IV hexagonal screwdriver bit as specified in Specification F116.

12
 F543 − 13´1

FIG. A5.1 Schematic of HA Screw Dimensions (Table A5.1)

TABLE A5.2 Dimensions for HA Screw Thread (Fig. A5.2)

Screw Type Thread Diameter, d1 Core Diameter, d5 Crest Width, e Thread Pitch, Leading Trailing Edge Leading Edge
Trailing Edge
and Size P Edge Radius, r5 Angle, α
Angle, β
Radius, r4
HA 1.5 1.50 +0.00 1.10 +0.00 0.1 0.5 0.3 0.1 35 3
−0.15 −0.10
HA 2.0 2.00 +0.00 1.30 +0.00 0.1 0.6 0.4 0.1 35 3
−0.15 −0.10
HA 2.7 2.70 +0.00 1.90 +0.00 0.1 1.0 0.6 0.2 35 3
−0.15 −0.15
HA 3.5 3.50 +0.00 2.40 +0.00 0.1 1.25 0.8 0.2 35 3
−0.15 −0.15
HA 4.0 4.00 +0.00 2.90 +0.00 0.1 1.5 0.8 0.2 35 3
−0.15 −0.15
HA 4.5 4.50 +0.00 3.00 +0.00 0.1 1.75 1.0 0.3 35 3
−0.15 −0.15
HA 5.0 5.00 +0.00 3.50 +0.00 0.1 1.75 1.0 0.3 35 3
−0.15 −0.15

FIG. A5.2 Schematic of HA Screw Thread Dimensions (Table A5.2)

TABLE A5.3 Dimensions for HB Screws (Fig. A5.3)

Screw Type and Head Diameter, d2 Shaft Diameter, d4 Head Height, k Bottom Head Radius, r1 Top Head Radius, r2 Screwdriver SizeA
Size
HB 4.0 6.00 +0.00 2.40 +0.00 2.9 3.250 +0.000 2.5 2.5
−0.15 −0.15 −0.075
HB 6.5 8.00 +0.00 4.50 +0.00 4.6 4.250 +0.000 2.5 3.5
−0.15 −0.15 −0.075
A
Type IV hexagonal screwdriver bit as specified in Specification F116.

13
 F543 − 13´1

FIG. A5.3 Schematic of HB Screw Dimensions (Table A5.3)

TABLE A5.4 Dimensions for HB Screw Thread (Fig. A5.4)

Screw Type and Thread Diameter, d1 Core Diameter, d5 Crest Width, e Thread Pitch, P Leading Edge Trailing Edge Leading Trailing Edge
Size Radius, r4 Radius, r5 Edge Angle, Angle, β
α
HB 4.0 4.00 +0.00 1.90 +0.00 0.1 1.75 0.8 0.3 25 5
−0.15 −0.15
HB 6.5 6.50 +0.00 3.00 +0.00 0.2 2.75 1.2 0.8 25 5
−0.15 −0.15

FIG. A5.4 Schematic of HB Screw Thread Dimensions (Table A5.4)

TABLE A5.5 Torsional Strength and Breaking Angle

Requirements for HA and HB Screws
Type and Size Minimum Acceptable Values
Torque, Nm† Breaking Angle, °, with
Five Exposed Threads
HA 1.5 0.2 150
HA 2.0 0.35 150
HA 2.7 1.0 180
HA 3.5 2.3 180
HA 4 4.0 180
HA 4.5 4.4 180
HA 5 5.5 180
HB 4 1.3 90
HB 6.5 6.2 90
†Unit of measure was editorially corrected.

14
 F543 − 13´1

A6. SPECIFICATIONS FOR HC AND HD METALLIC MEDICAL BONE SCREWS

A6.1 Screw Classification A6.3 Drive Connections

A6.1.1 There are a large variety of medical bone screws A6.3.1 Screws conforming to this specification, and desig-
currently in use. They may be classified by the definitions nated with either the HC or HD classification shall be fabri-
provided in Section 4. This specification includes the following cated with the following drive connections in accordance with
types of screws with a solid head and a solid core: the dimensions and tolerances found in Annex A7.
A6.1.1.1 Type HC— Conical undersurface of head, sym- A6.3.1.1 Type HC:
metrical thread. (1) Single-slot recess for accepting the Specification F116
A6.1.1.2 Type HD— Conical undersurface of head, asym- Type I—single-slot bit.
metrical thread. (2) Cruciate recess for accepting the Specification F116
A6.2 Screw and Thread Form Dimensions Type II—cruciate-slot bit.
(3) Combined cruciate-slot and cross-slot recess for accept-
A6.2.1 There are many types of metallic bone screw designs ing either the Specification F116 Type II—cruciate-slot or Type
available, so a complete list of dimensions and tolerances for III—cross-slot (modified Phillips) bits.
all screws covered by this specification is unfeasible. This
A6.3.1.2 Type HD—Combined single-slot and cross-slot
specification specifies dimensions and tolerances for two types
recess for accepting either the Specification F116 Type
of screws that are classified in 4.1. Screws conforming to this
I—single-slot or Type III—cross-slot (modified Phillips) bits.
specification, and designated with either the HC or HD
classification shall be fabricated in accordance with the dimen- A6.4 Performance Requirements
sions and tolerances in this Annex in accordance with the
following requirements. A6.4.1 Screws that meet the dimensional requirements of
A6.2.1.1 Type HC: the HC or HD screws in A6.2 shall be tested to document the
(1) Screw Dimensions—The dimensions of HC screws are following mechanical performance characteristics.
given in Table A6.1 and Fig. A6.1. A6.4.1.1 Torsional strength—A minimum of five screws for
(2) Screw Thread—The dimensions of the threads of HC a particular type and size shall be tested in accordance with the
screws are given in Table A6.2 and Fig. A6.2. methods described in Annex A1, with five threads exposed in
A6.2.1.2 Type HD: the gage length.
(1) Screw Dimensions—The dimensions of HD screws are A6.4.1.2 Breaking angle—A minimum of five screws for a
given in Table A6.3 and Fig. A6.3. particular type and size shall be tested in accordance with the
(2) Screw Thread—The dimensions of the threads of HD methods described in Annex A1, with five threads exposed in
screws are given in Table A6.4 and Fig. A6.4. the gage length.

FIG. A6.1 Schematic of HC Screw Dimensions (Table A6.1)

15
 F543 − 13´1

FIG. A6.2 Schematic of HC Screw Thread Dimensions (Table A6.2)

FIG. A6.3 Schematic of HD Screw Dimensions (Table A6.3)

FIG. A6.4 Schematic of HD Screw Thread Dimensions (Table A6.4)

TABLE A6.1 Dimensions for HC Screws (Fig. A6.1)

Screw Shaft Head Head Unthreaded Top Head
Type and Diameter, Diameter, Height, Length, Radius, r2
Size d1 d2 h x
HC 2.9 2.9 4.62 – 6.1 1.5 - 2 1.6 5
HC 3.5 3.5 5.8 – 6.5 1.5 - 2 1.6 6.35
HC 3.9 3.9 5.8 – 6.5 1.5 - 2 1.6 6.35
HC 4.2 4.2 5.8 – 6.5 1.5 - 2 1.6 6.35

16
 F543 − 13´1
TABLE A6.2 Dimensions for HC Screw Thread (Fig. A6.2)
Screw Type Thread Diameter, Core Diameter, Thread Pitch, c
and Size d1 d5 P max
HC 2.9 2.79 – 2.90 2.03 – 2.18 1.06 0.1
HC 3.5 3.43 – 3.53 2.51 – 2.64 1.27 0.1
HC 3.9 3.78 – 3.91 2.77 – 2.92 1.27 0.1
HC 4.2 4.09 – 4.22 2.95 – 3.25 1.27 0.1

TABLE A6.3 Dimensions for HD Screws (Fig. A6.3)

Screw Type Shaft Head Diameter, Head Height, Unthreaded Head Top
and Size Diameter, d2 H Length, Radius,
d4 x r1
HD 4.0 4.0 6.75 – 7.35 1.8 – 2.1 1.6 6.35
HD 4.5 4.5 6.75 – 7.35 1.8 – 2.1 1.6 6.35

TABLE A6.4 Dimensions for HD Screw Thread (Fig. A6.4)

Screw Thread Core Crest Thread Leading Trailing
Type Diameter, Diameter, Width, Pitch, Edge Edge
and d1 d5 e P Angle, Angle,
Size α β
HD 4 3.97 – 4.03 2.89 – 2.95 0.1 1.59 45 10
HD 4.5 4.47 – 4.53 2.89 – 2.95 0.1 2.18 45 10

A7. SPECIFICATIONS FOR METALLIC BONE SCREW DRIVE CONNECTIONS

A7.1. Scope A7.2.1.2 Cross-Recessed—This drive connection is illus-

A7.1.1 This annex specifies the requirements for a variety of trated in Fig. A7.2. Screws manufactured with this drive
drive connections that can be implemented in metallic medical connection can be driven with the Specification F116 Type
bone screws. The screw’s drive connection supplies the inter- III—cross-slot (modified Phillips) bit or the ISO 8319/2
connection that is typically used in orthopedic surgery for cross-recessed head screwdriver bit.
inserting and removing bone screws. A7.2.1.3 Combined Single-Slot and Cross-Recessed—This
drive connection is illustrated in Fig. A7.3. Screws manufac-
A7.2 Classification tured with this drive connection can be driven with the F116
A7.2.1 There are many methods that can be used to classify Type I—single-slot bit, Specification F116 Type III—cross-slot
medical bone screws. The majority of the methods currently (modified Phillips) bit, the ISO 8319/2 single-slot screwdriver
being used in the medical industry can be found in Section 3 of bit, or the ISO 8319/2 cross-recessed head screwdriver bit.
this specification. An additional characteristic not covered in A7.2.1.4 Cruciate-Slot—This drive connection is illustrated
Section 3 is the bone screw’s drive connection. This specifi- in Fig. A7.4. Screws manufactured with this drive connection
cation describes the following drive connections that are can be driven with the Specification F116 Type I—single-slot
compatible with the noted screwdriver bits. bit, Specification F116 Type II—cruciate-slot bit, the ISO
A7.2.1.1 Single-Slot—This drive connection is illustrated in 8319/2 single-slot screwdriver bit, or the ISO 8319/2 cruciate-
Fig. A7.1. Screws manufactured with this drive connection can slot screwdriver bit.
be driven with the Specification F116 Type I—single-slot bit or
the ISO 8319/2 single-slot screwdriver bit.

FIG. A7.1 Schematic of Screw with Single-Slot Drive Connection FIG. A7.2 Schematic of Screw with Cross-Recessed Drive Con-
(Table A7.1) nection (Table A7.2)

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 F543 − 13´1

FIG. A7.3 Schematic of Screw with Combined Single-Slot and

Cross-Recessed Drive Connection (Table A7.3)
FIG. A7.6 Schematic of Screw with Hexagonal Drive Connection
(Table A7.6)

FIG. A7.4 Schematic of Screw with Cruciate-Slot Drive Connec-

tion (Table A7.4)

A7.2.1.5 Combined Cruciate-Slot and Cross-Recessed—

FIG. A7.7 Schematic of Screw with Square Drive Connection
This drive connection is illustrated in Fig. A7.5. Screws (Table A7.7)
manufactured with this drive connection can be driven with the
Specification F116 Type I—single-slot bit, F116 Type II—
cruciate-slot bit, the Specification F116 Type III—Cross-slot
(modified Phillips) bit, the ISO 8319/2 single-slot screwdriver
bit, ISO 8319/2 cruciate-slot screwdriver bit, or the ISO 8319/2
crossed-recessed head screwdriver bit.
A7.2.1.6 Hexagonal—This drive connection is illustrated in
Fig. A7.6. Screws manufactured with this drive connection can
be driven with the Specification F116 Type IV—hexagonal or
the ISO 8319/1 hexagonal screwdriver bit.
A7.2.1.7 Square—This drive connection is illustrated in Fig.
A7.7. At this time no standard screwdriver bit is specified for
this drive connection. Screws manufactured with this drive
connection can be driven with square drive screwdriver bits.
A7.2.1.8 Hexalobe—This drive connection is illustrated in FIG. A7.8 Schematic of Screw with Hexalobe Drive Connection
Fig. A7.8. At this time no standard screwdriver bit is specified (Table A7.8)
for this drive connection. Screws manufactured with this drive
connection can be driven with hexalobe (six-lobe) screwdriver
bits that conform to ISO 10664 Standard for Hexobular internal A7.3 Dimensions
driving feature for bolts and screws.. A7.3.1 Medical bone screws conforming to this specifica-
tion are as follows:
A7.3.1.1 Single-Slot—The dimensions for this drive con-
nection are given in Table A7.1 and Fig. A7.1.
A7.3.1.2 Cross-Recessed—The dimensions for this drive
connection are given in Table A7.2 and Fig. A7.2.
A7.3.1.3 Combined Single-Slot and Cross-Recessed—The
dimensions for this drive connection are given in Table A7.3
and Fig. A7.3. The maximum depth of the recess shall be such
that the torque strength of the screw is unaffected.
A7.3.1.4 Cruciate-Slot—The dimensions for this drive con-
nection are given in Table A7.4 and Fig. A7.4.
FIG. A7.5 Schematic of Screw with Combined Cruciate-Slot and A7.3.1.5 Combined Cruciate-Slot and Cross-Recessed—
Cross-Recessed Drive Connection (Table A7.5) The dimensions for this drive connection are given in Table

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 F543 − 13´1
TABLE A7.1 Single-Slot Drive Connection Dimensions (Fig. A7.1)
Screw Type and Size Nominal Diameter, Slot Width, g, mm
mm
HC 2.9 2.9 1.25 - 1.4
HC 3.5 3.5 1.25 - 1.4
HC 3.9 3.9 1.25 - 1.4
HC 4.2 4.2 1.25 - 1.4

TABLE A7.2 Cross-Recessed Drive Connection Dimensions (Fig.

A7.2)
Nominal d b max n
Diameter, mm
4.5 5 3.8 1.4

TABLE A7.3 Combined Single-Slot and Cross-Recessed Drive

Connection Dimensions (Fig. A7.3)
Screw Type and Size Slot Width, g, mm Slot Angle, α, °
HD 4.0 1.25 - 1.4 60
HD 4.5 1.25 - 1.4 60

TABLE A7.4 Cruciate-Slot Drive Connection Dimensions (Fig.

A7.4)
Screw Type and Size Nominal Diameter, Slot Width, g, mm
mm
HC 3.5 3.5 1.25 - 1.4
HC 3.9 3.9 1.25 - 1.4
HC 4.2 4.2 1.25 - 1.4

A7.5 and Fig. A7.5. The maximum depth of the recess shall be A7.3.1.8 Hexalobe—The dimensions for this drive connec-
such that the torque strength of the screw is unaffected. tion are given in Table A7.8 and Fig. A7.8. The maximum
A7.3.1.6 Hexagonal—The dimensions for this drive con- depth of the recess shall be such that the torque strength of the
nection are given in Table A7.6 and Fig. A7.6. screw is unaffected.
A7.3.1.7 Square: The dimensions for this drive connection
are given in Table A7.7 and Fig. A7.7. The maximum depth of
the recess shall be such that the torque strength of the screw is
unaffected.

TABLE A7.5 Combined Cruciate-Slot and Cross-Recessed Drive

Connection Dimensions (Fig. A7.5)
Screw Type and Nominal Slot Width, g, mm Slot Angle, α, °
Size Diameter, mm
HC 3.5 3.5 1.25 - 1.4 60
HC 3.9 3.9 1.25 - 1.4 60
HC 4.2 4.2 1.25 - 1.4 60

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 F543 − 13´1
TABLE A7.6 Hexagonal Drive Connection Dimensions (Fig. A7.6)
Screw Type Nominal Screwdriver Bit SW, mm t, mm
and Size Diameter, mm Size
HA 1.5 1.5 1.5 1.507 +0.040 0.8
−0.000
HA 2.0 2.0 1.5 1.507 +0.040 1.0
−0.000
HA 2.7 2.7 2.5 2.507 +0.040 1.2
−0.000
HA 3.5 3.5 2.5 2.507 +0.040 1.5
−0.000
HA 4.0 4.0 2.5 2.507 +0.040 1.5
−0.000
HA 4.5 4.5 3.5 3.510 +0.048 2.8
−0.000
HA 5.0 4.5 3.5 3.510 +0.048 2.8
−0.000
HB 4.0 4.0 2.5 2.507 +0.040 1.5
−0.000
HB 6.5 6.5 3.5 3.510 +0.048 2.8
−0.000

TABLE A7.7 Square Drive Connection Dimensions (Fig. A7.7)

Screw Size SW, mm
1.0 0.7
1.5 1.0
2.0 1.27

TABLE A7.8 Hexalobe Drive Connection Dimensions (Fig. A7.8)

Drive Size A, (mm) B, (mm) E Radius, (mm) F Radius, (mm) β, (°) Screwdriver Bit
Size
4 1.35 0.97 0.28 0.12 140 4
5 1.47 1.07 0.30 0.14 140 5
6 1.75 1.27 0.36 0.16 140 6
8 2.4 1.75 0.49 0.22 140 8
10 2.8 2.05 0.57 0.25 140 10
15 3.35 2.40 0.69 0.30 140 15
20 3.95 2.85 0.83 0.34 140 20
25 4.50 3.25 0.89 0.40 140 25
30 5.60 4.05 1.16 0.48 140 30

APPENDIX

(Nonmandatory Information)

X1. METALLIC BONE SCREWS

X1.1 This specification is intended to provide useful and X1.2.2 Nitrogen-strengthened stainless steel alloy (Specifi-
consistent information related to the performance, terminology, cations F1314 and F1586)
requirements for materials, finish and marking considerations, X1.2.3 Unalloyed titanium (Specification F67).
and care and handling of metallic bone screws. It includes the
terms and requirements of Specification F543-98. This speci- X1.2.4 Titanium-aluminum-vanadium alloy (Specifications
fication also includes the test methods that were previously F136, F620, and F1472).
published separately as Specifications F117, F1622, and X1.2.5 Titanium-aluminum-niobium alloy (Specification
F1691.5 F1295).
X1.2 Materials which have been found acceptable for me- X1.2.6 Titanium-niobium-zirconium alloy (Specification
tallic bone screws includes: F1713).
X1.2.1 Stainless steel alloy (Specification F138). X1.2.7 Cobalt-chromium-molybdenum alloy (Specifica-
tions F799 and F1537).
5
Discontinued; see 2000 Annual Book of ASTM Standards, Vol 13.01. Replaced X1.2.8 Titanium-molybdenum-zirconium-iron alloy (Speci-
May 2001 by Specification and Test Methods F543. fication F1813).

20
 F543 − 13´1
X1.2.9 Titanium-molybdenum-zirconium-iron alloy (Speci- partially threaded screws, the length of the unthreaded portion
fication F2066). of the screw and the threaded portion can vary considerably
among different types of screws. Because of this variation, no
X1.3 Dimensional requirements are provided for four spe- exact method of fixation is required. Suggestions are made to
cific types of bone screws. These screws, specified here as grip enough threads to hold the screw in a fixed position with
Specification F543 Types HA and HB, HC, and HD are possibly one or more thread(s) exposed. If this condition is not
dimensionally similar to those specified in ISO 5835 and ISO possible, then all threads must be gripped. In any case, the
9268. The dimensions and performance of these types of experiment is required to record the gage length and the
screws are specified because they have achieved widespread gripping length.
clinical use and are offered by several manufacturers. Stan-
dardization of the dimensions and tolerances of the key X1.5.4 If an axial force is necessary to engage the screw-
features of these screws is intended to allow the implants from driver in the screw head, the value of this force shall be
one manufacturer to be used with the associated instruments determined by the operator. The force should be the minimum
(taps, drills, and so forth) from different manufacturers and needed to engage the screwdriver bit with the screw head.
serve as a baseline for future screw products. This may benefit
X1.6 This specification provides a uniform test procedure
the surgeon and patient by aiding the identification of the
for measuring the insertion and removal torque of bone screws
appropriate instrumentation for the implantation and removal
in a specified medium. This specification can thus provide a
of screws by the operating room staff.
measure of the uniformity of the products tested or compare the
X1.4 Performance requirements are provided for two spe- insertion and removal torque among similar or dissimilar
cific types of bone screws. Those that have a solid core and a screws.
spherical head, specified here as Specification F543 Type HA X1.6.1 The test method specifies that the bone screw be
and HB, have performance specifications developed from those driven at a rate of 1 to 5 r/min into the test block. The rate
specified in ISO 6475. Standardization of the performance specified in the original Test Method F1175 standard was
requirements and harmonization of these requirements with the selected and based upon the limitations of torsion test systems
similar screws described in ISO standards is intended to when the standard was originally developed. Faster driving
facilitate the approval to market for manufacturers declaring rates (an order of magnitude greater at 30 r/min) can better
conformity to either or both standards. simulate the clinical situation for hand-driven screws.
X1.5 This specification provides minimum performance Therefore, the user may choose to use higher screw-driving
limits for the torsional properties of bone screws and a uniform rates, as long as the selected rate is justified and reported. All
test procedure by which these limits can be determined. The comparative test methods must be performed at the same
parameters specified in this specification are breaking torque driving rate.
and breaking angle. X1.6.2 During the development of this test method, the
X1.5.1 The breaking torque is intended to be a measure of committee noted the need to test sterilized screws. Infection
the screw’s strength. Torque was determined to be the critical Control and Sterilization Technology, V4, No 8 p12, August
parameter in the insertion of screws into a uniform medium. 1998 reported differences in the driving torque when sterilized
Unpublished test reports indicated that a screw could experi- and unsterilized screws were tested.
ence both torsional and tensile forces when inserted into a
X1.7 This specification provides a uniform test procedure
uniform medium. If the screw was inserted until it ruptured,
for measuring the axial pullout strength of bone screws from a
then the torsional forces appear to dominate over the tensile
specified medium. This specification can provide a measure of
forces. Therefore, tensile forces were neglected in analyzing
the uniformity of the products tested or compare the pullout
screw strength.
strength among similar or dissimilar screws.
X1.5.2 The breaking angle is a measure of the screw’s
ductility. For example, a screw that has a breaking angle of X1.8 During the 2011 periodic review of the standard, the
360° is more ductile than one with the same design that breaks subcommittee received comments from members noting that
at 120° under the same test conditions. Since this parameter Specification F543 did not include manufacturing tolerances
does not represent the point at which the screw loses its elastic for the dimensions in the specifications for Type V Square and
properties, a torsional yield measurement was devised. This Type VI Hexalobe screwdriver connections. The subcommittee
point is intended to present an approximate measure of the established that there are no published tolerances for the Type
torque at which the screw loses its elastic properties. The task V Square connection. However, a standard relevant to Type VI
force decided that an offset method with a 2° angle offset Hexalobe was identified (ISO 10664) and is included as a
method was considered to yield the most consistent results. reference. The subcommittee believes that deletion of the
X1.5.3 The breaking force test method provides a consistent information on these connections from the standard will detract
measurement method for fully threaded bone screws. For from the value of the standard as a whole.

21
 F543 − 13´1
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