ASTM F 543

JANVIER 2017

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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Designation: F543 − 17

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.

1. Scope particular device design. This may only be a subset of the

1.1 This specification provides requirements for materials, herein described test methods.
finish and marking, care and handling, and the acceptable 1.6 This standard may involve the use of hazardous
dimensions and tolerances for metallic bone screws that are materials, operations, and equipment. This standard does not
implanted into bone. The dimensions and tolerances in this purport to address all of the safety concerns, if any, associated
specification are applicable only to metallic bone screws with its use. It is the responsibility of the user of this standard
described in this specification. to establish appropriate safety and health practices and
determine the applicability of regulatory limitations prior to
1.2 This specification provides performance considerations
use.
and standard test methods for measuring mechanical properties
1.7 This international standard was developed in accor-
in torsion of metallic bone screws that are implanted into bone.
dance with internationally recognized principles on standard-
These test methods may also be applicable to other screws
ization established in the Decision on Principles for the
besides those whose dimensions and tolerances are specified
Development of International Standards, Guides and Recom-
here. The following annexes are included:
mendations issued by the World Trade Organization Technical
1.2.1 Annex A1—Test Method for Determining the Tor-
Barriers to Trade (TBT) Committee.
sional Properties of Metallic Bone Screws.
1.2.2 Annex A2—Test Method for Driving Torque of Medi-
cal Bone Screws. 2. Referenced Documents
1.2.3 Annex A3—Test Method for Determining the Axial 2.1 ASTM Standards:2
Pullout Strength of Medical Bone Screws. E4 Practices for Force Verification of Testing Machines
1.2.4 Annex A4—Test Method for Determining the Self- E6 Terminology Relating to Methods of Mechanical Testing
Tapping Performance of Self-Tapping Medical Bone Screws. E8 Test Methods for Tension Testing of Metallic Materials
1.2.5 Annex A5—Specifications for Type HA and Type HB E122 Practice for Calculating Sample Size to Estimate, With
Metallic Bone Screws. Specified Precision, the Average for a Characteristic of a
1.2.6 Annex A6—Specifications for Type HC and Type HD Lot or Process
Metallic Bone Screws. F67 Specification for Unalloyed Titanium, for Surgical Im-
1.2.7 Annex A7—Specifications for Metallic Bone Screw plant Applications (UNS R50250, UNS R50400, UNS
Drive Connections. R50550, UNS R50700)
1.3 This specification is based, in part, upon ISO 5835, ISO F86 Practice for Surface Preparation and Marking of Metal-
6475, and ISO 9268. lic Surgical Implants
F116 Specification for Medical Screwdriver Bits
1.4 The values stated in SI units are to be regarded as F136 Specification for Wrought Titanium-6Aluminum-
standard. No other units of measurement are included in this 4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical
standard. Implant Applications (UNS R56401)
1.5 Multiple test methods are included in this standard. F138 Specification for Wrought 18Chromium-14Nickel-
However, the user is not necessarily obligated to test using all 2.5Molybdenum Stainless Steel Bar and Wire for Surgical
of the described methods. Instead, the user should only select, Implants (UNS S31673)
with justification, test methods that are appropriate for a F565 Practice for Care and Handling of Orthopedic Implants
and Instruments
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 March 1, 2017. Published April 2017. Originally contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
approved in 1977. Last previous edition approved in 2013 as F543 – 13ε1. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F0543-17. the ASTM website.

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

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F620 Specification for Titanium Alloy Forgings for Surgical 3. Terminology
Implants in the Alpha Plus Beta Condition 3.1 Definitions—Some of the terms defined in this section
F799 Specification for Cobalt-28Chromium-6Molybdenum are shown in Fig. 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
R56400) FIG. 1 Schematic of Screw Terms
F1537 Specification for Wrought Cobalt-28Chromium-
6Molybdenum Alloys for Surgical Implants (UNS
3.1.1 axial pullout strength—the tensile force required to
R31537, UNS R31538, and UNS R31539)
fail or remove a bone screw from a material into which the
F1586 Specification for Wrought Nitrogen Strengthened
screw has been inserted.
21Chromium—10Nickel—3Manganese—
2.5Molybdenum Stainless Steel Alloy Bar for Surgical 3.1.2 breaking angle—angle of rotation when the screw fails
Implants (UNS S31675) in torsion as demonstrated by a rapid decrease in the indicated
F1713 Specification for Wrought Titanium-13Niobium- torque.
13Zirconium Alloy for Surgical Implant Applications 3.1.3 buttress thread—an asymmetrical thread profile char-
(UNS R58130) acterized by a pressure flank which is nearly perpendicular to
F1813 Specification for Wrought Titanium-12Molybdenum- the screw axis.
6Zirconium-2Iron Alloy for Surgical Implant (UNS 3.1.4 cancellous screw—a screw designed primarily to gain
R58120) purchase into cancellous bone. Cancellous screws typically
F1839 Specification for Rigid Polyurethane Foam for Use as have an HB (see 4.1.2) thread and may or may not be fully
a Standard Material for Testing Orthopaedic Devices and threaded.
Instruments 3.1.5 cortical screw—a screw designed primarily to gain
F2066 Specification for Wrought Titanium-15 Molybdenum biocortical purchase into cortical bone. Cortical screws typi-
Alloy for Surgical Implant Applications (UNS R58150) cally have a HA (see 4.1.1) thread and are fully threaded.
F2503 Practice for Marking Medical Devices and Other 3.1.6 core diameter—the smallest diameter of the threaded
Items for Safety in the Magnetic Resonance Environment portion of the screw measured at the thread root. This is also
2.2 ISO Standards:3 known as the minor diameter or root diameter.
5835 Implants for Surgery—Metal Bone Screws with Hex- 3.1.7 gage length—the distance between the holding device
agonal Driver Connection, Spherical Under Surface of (for example, a split collet) and the underside of the screw
Head, Asymmetrical Thread—Dimensions head.
6475 Implants for Surgery—Metal Bone Screws with Asym- 3.1.8 grip length—the length of threads held fast in the split
metrical Thread and Spherical Under-Surface— collet or other holding mechanism.
Mechanical Requirements and Test Methods
8319-1 Orthopaedic Instruments—Drive connections—Part 3.1.9 insertion depth—the threaded length as inserted into
the test block.
1: Keys for use with hexagon socket heads
8319-2 Orthopaedic Instruments—Drive connections—Part 3.1.10 insertion torque—the amount of torque required to
2: Screwdrivers for single slot head screws, screws with overcome the frictional force between the screw and the
cruciate and cross-ecessed head screws material used for testing while driving the screw into the
9268 Implants for Surgery—Metal Bone Screws with Coni- material.
cal Under-Surface of Head—Dimensions 3.1.11 maximum torque (N-m)—the largest value of torque
10664 Hexalobular Internal Driving Feature for Bolts and recorded during the period of rotation before screw failure in
Screws torsional shear when tested in accordance with Annex A1.
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
Available from American National Standards Institute, 25 W. 43rd St., 4th be inserted into the pilot hole before the insertion of the screw,
Floor, New York, NY 10036. when used in moderate or hard bone.

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3.1.13 partially threaded screw—a screw whose threaded 4.1.3 Type HC—Conical undersurface of head, symmetrical
portion does not extend fully from the screw point to the screw thread.
head but instead has a smooth shaft running between the head 4.1.4 Type HD—Conical undersurface of head, asymmetri-
and threads. cal thread.
3.1.14 pilot hole—the hole drilled into the bone into which 5. Material
the screw tip is inserted. The pilot hole is normally slightly
larger than the screw’s core diameter. However, if the screw is 5.1 Screws shall be fabricated from a metallic material
to be used to provide compression across a fracture, a portion intended for surgical implant applications, and meeting the
of the pilot hole may be larger to allow for a clearance fit. requirements for an ASTM medical material. In addition, the
materials shall be biocompatible for the intended application.
3.1.15 pitch—the length between the thread crests.
3.1.16 removal torque—the amount of torque required to 6. Dimensions and Tolerances
overcome the frictional force between the screw and the 6.1 There are many types of metallic bone screw designs
material used for testing while removing the screw from the available, so a complete list of dimensions and tolerances for
material (for example, counterclockwise rotation for right-hand all screws covered by this specification is unfeasible. However,
thread). this specification does provide required dimensions and toler-
3.1.17 screw head—the end of the screw which is opposite ances for four types of screws as classified in 4.1. Screws
of the tip and to which the means of inserting the screw is conforming to this specification, and designated HA, HB, HC,
coupled. or HD screws, shall be fabricated in accordance with the
dimensions and tolerances described in Annex A5 and Annex
3.1.18 screw length—the overall length of the screw mea-
A6.
sured from the screw head to the screw tip.
3.1.19 screw thread—a helical groove on a cylindrical or 7. Finish and Marking
conical surface. The projecting helical ridge thus formed is 7.1 The screw shall be free from nicks, dents, burrs, and
called a screw thread, consisting of peaks (crests) and valleys scratches when examined in accordance with Practice F86.
(roots).
7.2 When size permits, the following information should be
3.1.20 self-tapping force (N)—the amount of axial force legibly marked on the head of the screw (in order of prefer-
required to engage the self-tapping features of self-tapping ence):
style screws when tested in accordance with Annex A4. 7.2.1 Manufacturer’s name or logo,
3.1.21 self-tapping screw—a screw that has any number of 7.2.2 Screw Size—If a screw is manufactured in accordance
flutes at its tip which are intended to cut the screw’s thread with ASTM or ISO specifications, the ASTM or ISO designa-
form into the bone upon insertion. tion should be provided,
3.1.22 size—an identification of a screw based on its nomi- 7.2.3 Material,
nal thread diameter, as defined in Section 6. 7.2.4 Catalog number, and
7.2.5 Manufacturing lot number.
3.1.23 solid core—a screw that does not contain a cannula-
tion along its longitudinal axis. 7.3 Screws shall be marked in accordance with Practice
F983, unless otherwise specified in 7.2, in a manner such that
3.1.24 thread diameter—the largest diameter of the threaded
the mechanical integrity of the screw is not compromised.
portion of the screw measured over the thread crests. This is
also known as the major diameter. 8. Care and Handling
3.1.25 thread length—the length of the threaded portion of 8.1 Screws should be cared for and handled in accordance
the screw, measured from the thread runout to the screw tip. with Practice F565, as appropriate.
3.1.26 thread runout—the intersection of the screw thread 8.2 Consider Practice F2503 to identify potential hazards
with either the screw shaft or screw head. produced by interactions between the device and the MR
3.1.27 torsional yield strength (N-m)—the point at which environment and for terms that may be used to label the device
the screw reaches its proportional limit when tested in accor- for safety in the MR environment.
dance with Annex A1. This will be determined by the offset
9. Driving Instruments
method. A 2° offset value shall be used.
9.1 A variety of screwdrivers for the insertion and removal
4. Classification of bone screws exist. The classification and dimensions for
4.1 There are a large variety of medical bone screws various screw-drive recesses currently used in the medical
currently in use. They may be classified by the definitions industry are documented in Annex A7. Specification F116
provided in Section 3. This specification currently includes provides related dimensional information for several types of
information that defines the following types of screws: medical screwdrivers.
4.1.1 Type HA—Spherical undersurface of head, shallow, 9.2 Screws conforming to this specification, and designated
asymmetrical buttress thread, and deep screw head. HA, HB, HC, or HD screws, shall be manufactured with drive
4.1.2 Type HB—Spherical undersurface of head, deep, recesses that conform to the requirements specified in Annex
asymmetrical buttress thread, and shallow screw head. A5 and Annex A6.

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10. Performance Considerations and Test Methods and to ensure that the screw may be easily inserted by the
surgeon. The insertion torque should be much less than
10.1 The following properties may be important when
torsional yield strength of the screw and of the appropriate
determining the suitability of a screw for a particular applica-
screwdriver bit. The insertion torque may be determined using
tion. However, the test methods referenced as follows may not
the test methods described in Annex A2.
be appropriate for all types of implant applications. The user is
10.1.5 Removal Torque—This test method may be an im-
cautioned to consider the appropriateness of the test methods in
portant parameter to avoid failure of the screw during removal
view of the devices being tested and their potential application.
and to ensure that the screw may be easily removed by the
10.1.1 Torsional Strength—This test method is an important surgeon. The removal torque should be much less than tor-
parameter to prevent screw breakage during insertion or sional yield strength of the screw and of the appropriate
removal. The torsional strength shall be determined using the screwdriver bit. The removal torque may be determined using
test methods described in Annex A1. the test methods described in Annex A2.
10.1.2 Breaking Angle—This test method provides a mea- 10.1.6 Self-Tapping Force—This test method may be an
sure of the ductility of the screw when undergoing a torsional important parameter to ensure that the screw may be easily
moment. A screw with a greater breaking angle may provide an inserted by the surgeon, particularly if the screw is fixed in
earlier tactile warning to the surgeon that the screw is reaching poor quality or osteoporotic bone. The self-tapping force may
its maximum torsional strength. The breaking angle shall be be determined using the test method described in Annex A4.
determined using the test methods described in Annex A1.
10.1.3 Axial Pullout Strength—This test method may be an 11. Performance Requirements
important parameter if the screw is subjected to axial tensile 11.1 Screws shall meet the mechanical performance require-
forces, or if the screw is fixed into poor quality or osteoporotic ments specified in its associated specification annex.
bone. The pullout strength may be determined using the test
methods described in Annex A3. 12. Keywords
10.1.4 Insertion Torque—This test method may be an im- 12.1 bone screw; dimensions; insertion; performance re-
portant parameter to avoid failure of the screw during insertion 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

4
A1.2.1.2 Torque Transducer—A transducer to translate the
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 applied torque into an electrical signal amenable to continuous
to review Terminology E6 and Test Methods E8 for general guidance. recording, calibrated over the range of torques, both in the

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clockwise and counterclockwise rotation, to be encountered in be noted. The torque wrench shall be driven at a rate of 1 to 5
the test method, shall be provided. revolutions/min (r/min).
A1.2.1.3 Torsional Displacement Transducer—A transducer NOTE A1.1—The simultaneous use of two chart recorders may simplify
to translate the angle of twist into an electrical signal amenable the ability to measure torsional yield strength accurately by the offset
to continuous recording, calibrated over the range of angles to method. One chart recorder with an angular displacement scale or
be encountered in the test and an accuracy of 60.3°, both in the sensitivity of 50°/cm is convenient for measuring maximum torque and
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
A1.2.1.4 Specimen Holder—A mechanical device to clamp measurement capability for measuring a 2° angular displacement.
onto the bone screw to prevent its rotation while being stressed Alternatively, one chart recorder and a digital storage oscilloscope may be
without significantly damaging its mechanical integrity shall be used.
provided. One such method is to insert a threaded stopper into A1.3.3 The torsional yield strength will be determined by
the opposite side of a test block. The test block for this holding the offset method (Fig. A1.2), using the torque versus angle of
mechanism will accommodate the insertion of a threaded rotation curve produced in A1.3.1 and A1.3.2.
stopper on the other side of the test block. The threaded stopper A1.3.3.1 On the torque versus angle of rotation curve, locate
will prevent the screw from being completely inserted into the Point m equal to a rotation of 2°. Draw mn parallel to OA, and
test block and will allow the torsional strength of the screw to locate b, the intersection of mn with the torque versus angle of
be measured. This holder will be modified according to the size rotation curve. Torque B is defined as the torsional yield
of the testing specimen so that the gage length of the specimen strength.
will be as outlined in A1.3.1. A1.3.3.2 The maximum torque is determined by the largest
A1.2.1.5 Recorder—The data recorder shall be suitable to value of torque on the torque versus angle of rotation curve.
continuously record torque versus angle of rotation, calibrated A1.3.3.3 The breaking angle is determined from the torque
in units of Newton-metres for torque and degrees for angle of versus angle plot shown in Fig. A1.3. The breaking angle is
rotation. The value of torque shall have a resolution of 5 % of defined as the point at which the torque portion of the curve
torsional yield strength. The angular displacement scale shall demonstrates its most rapid descent (negative slope) to total
have a minimum sensitivity so as to enable an accurate offset failure. The breaking angle (B.A.) is determined as the inter-
measurement capability for a 2° angular displacement (see section of the two tangents (D and E) shown in Fig. A1.3. Line
A1.3.3). E is a tangent to the horizontal portion of the curve which
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
procedures may be used. For fully threaded screws that are too
small, the gage length of the specimen should represent 20 %
of the threaded portion of the test specimen. For partially
threaded screws, a large enough portion of the screw thread
should be gripped to firmly secure the screw so that it does not
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 FIG. A1.2 Typical Torque Versus Angle of Rotation Curve

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A1.4.1.3 Surface finish.
A1.4.1.4 Gage length.
A1.4.1.5 Torsional yield strength.
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
FIG. A1.3 Typical Plot of Torque Versus Torsion Angle
screw fails or by measuring the distance below the head to the
approximate fracture point.
major and minor diameter, thread pitch, overall screw length,
head and shank (unthreaded portion of the screw excluding the A1.5. Precision and Bias
head) length, and type of screw point. A1.5.1 Data establishing the precision and bias to be ex-
A1.4.1.2 Screw chemical composition. 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 A2.2. Apparatus
required to drive a bone screw into a standard material. The
A2.2.1 Testing Fixture—A suitable test fixture as shown in
results obtained in this test method bear no direct correlation to
the insertion torque required to insert the subject bone screw in Fig. A2.1 may be used for the insertion-removal torque tests.4
human or animal bone. This test method should be used only This fixture shall incorporate the test block material that
for the purpose of maintaining the uniformity of the product conforms to Specification F1839, test block clamp, drill
tested. bushing, and bushing support depicted. It shall be sufficiently

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

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rigid to not deflect or deform under the conditions of loading screw manufacturer, for the size screw being tested. If specified
encountered during the test. by the screw manufacturer, the specified sized tap shall be used
A2.2.1.1 Torque Transducer—A transducer to convert the to tap the pilot hole before testing. The holes shall be drilled at
applied torque into an electrical signal amenable to continuous 90° to the top surface of the test block. The holes shall be
recording, calibrated over the range of torques, both in the drilled straight and true, free of taper, bell mouth, or barrel
clockwise and counterclockwise rotation, to be encountered in shape. If there are multiple holes in one test block, the pilot
the test shall be provided. holes shall be spaced sufficiently far away from test block
A2.2.1.2 Torsional Displacement Transducer—A transducer edges so that testing does not deform the test block edges.
to translate the angle of twist into an electrical signal amenable Spacing should have a minimum distance of 5× the diameter of
to continuous recording, calibrated in a manner similar to the screw. When the test block is inserted into the test fixture
Practices E4 over the range of angles to be encountered in the (Fig. A2.1), the pilot hole, screw, and screwdriver shall be on
test to an accuracy of 60.3°, both in the clockwise and the same axis.
counterclockwise rotation, shall be provided.
A2.2.1.3 Data Recorder—The data recorder shall be suit- A2.3. Sampling
able to record torque versus angle of rotation continuously, A2.3.1 Representative random samples may be taken from
calibrated in units of newton-metres for torque and degrees for each lot or processing quantity in accordance with Practice
angle of rotation. The value of torque shall have a resolution of E122.
10 % of the maximum measured torque. The angular displace-
ment scale shall have sensitivity such that at least four A2.4. Procedure
revolutions can be recorded and displayed. A2.4.1 Insertion and Removal Torque—Place the specimen
A2.2.1.4 Bushing—A suitable replaceable bushing, fabri- in the test fixture as illustrated in Fig. A2.1. Drive the specimen
cated from material that conforms to Specification F1839, shall into the test block, using the appropriate size and configured
be incorporated into the testing fixture. This bushing shall be of screwdriver bit, by applying a torsional force at a rate of 1 to
sufficient length and rigidity to ensure that specimens are 5 r/min, to the head of the specimen with the motor-driven
driven into the test block normal to the top surface of the test torque wrench. The insertion torque shall be the maximum
block. The bore of the bushing shall be of such dimension as to reading recorded during the initial four revolutions of the
ensure guidance of the test specimen with minimum frictional specimen. The removal torque shall be measured by reversing
resistance between the major diameter of the test specimen and the direction of rotation and recording the maximum torque
the bore of the bushing. Worn bushings shall be discarded and recorded during the four revolutions required to remove the
replaced with new bushings before conducting the test. screw from the test block. Values should be reported in
A2.2.1.5 Test Block Clamp—A clamp or holding device Newton-metres. A 1.14-kgf or less axial load should be used to
shall be incorporated into the testing fixture. This holding maintain the screwdriver bit in the screw head during both the
device shall maintain the drilled pilot hole in the test block in insertion and removal procedures. If a larger axial load is
line with the test specimen. The holding device shall not applied, this load shall be recorded on the report form. This
deform the test block during clamping of the test block or load may be measured by any appropriate method.
performance of the test.
A2.2.1.6 Test Specimen—The test specimen shall be a A2.5. Report
completely fabricated, finished, and sterilized bone screw of A2.5.1 The report shall include the following for each
sufficient length to transverse the bushing and test block. specimen tested. (All standards units for reporting shall be in
A2.2.1.7 Test Block—The test block shall be fabricated from SI units.)
a uniform material that conforms to Specification F1839. The A2.5.1.1 Screw Identification—Reference any applicable
choice of appropriate foam density for this test is at the ASTM or ISO standard specification that may apply to the
discretion of the user. See Section 8.6.2 of F1839 for additional specimen. If specifications do not exist, provide head form,
information. To accommodate the requirements of the pilot thread form, major and minor diameter, thread pitch, overall
hole as described in A2.2.1.8, the smallest dimension of the test screw length, head and shank (unthreaded portion of the screw
block’s surface shall be greater than 10× the diameter of the excluding the head) length, and type of screw point.
screw under test. The top and bottom surfaces shall be flat, A2.5.1.2 Screw chemical composition.
smooth, and parallel (within 60.4 mm) as required to ensure A2.5.1.3 Surface finish.
that the test block will be supported in the fixture with the top A2.5.1.4 Insertion torque.
surface at an angle of 90° to the centerline of the test specimen. A2.5.1.4.1 Axial load required.
The edges of the test block shall be of such contour or A2.5.1.4.2 Insertion depth (may be calculated or measured).
squareness as required to ensure that the test block clamp shall 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 pretapped, specifications of the tap size,
of the test block during clamping or testing. The test block tap 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.

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A2.5.1.5.2 Removal test speed if outside the range specified A2.5.1.6.4 Tensile strength.
in A2.4.1. A2.5.1.6.5 Compression strength.
A2.5.1.6 Test Block Material Description—Specification A2.5.1.6.6 Shear strength.
F1839 grade. For bushing material that does not conform to
Specification F1839, provide
A2.6. Precision and Bias
A2.5.1.6.1 Trade name.
A2.5.1.6.2 Composition. A2.6.1 Data establishing the precision and accuracy to be
A2.5.1.6.3 Density. 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 test method, Annex A2. In addition to these requirements, the
force required to fail or remove a bone screw from a defined test block clamp and bushing support should be sufficiently
material. The results obtained in this test method are not rigid such that deflection under the required loading conditions
intended to predict the force required to remove the subject is negligible. The test block clamp should have a minimum
bone screw from human or animal bone. This test method is grip span of five times the major diameter of the bone screw
intended only to measure the uniformity of the products tested with the screw centered between the grips. The grip span
or to compare the strength of different products. should be consistent throughout testing.
A3.1.2 This test method may not be appropriate for all types A3.2.2 Test Block—The test block shall be fabricated from a
of implant applications. The user is cautioned to consider the uniform material that conforms to Specification F1839. The
appropriateness of the method in view of the materials being choice of appropriate foam density for this test is at the
tested and their potential application. discretion of the user. See Section 8.6.2 of F1839 for additional
information. The top and bottom surfaces shall be flat, smooth,
A3.2. Apparatus and parallel (within 60.4 mm) as required to ensure that the
A3.2.1 Test Fixture—Machines used for testing the axial test block will be supported in the fixture with the top surface
pullout strength of screws shall conform to the requirements of at an angle of 90° to the centerline of the test specimen. The
Practices E4. A suitable test fixture as shown in Fig. A3.1 may edges of the test block shall be of such contour or squareness
be used. This fixture shall incorporate the test block material as required to ensure that the test block clamp shall hold the
which conforms to Specification F1839, test block clamp, drill test block free of relative motion without deformation of the
bushing, and bushing support depicted in the insertion torque test block during clamping or testing. The test block thickness
shall be not less than 20 mm.
A3.2.3 Data Acquisition Device—The data recorder shall be
suitable to continuously record load versus load fixture dis-
placement.
A3.2.4 Load Frame—Machines used for testing shall con-
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-
FIG. A3.1 Schematic of Test Apparatus for Pullout Strength plant quality products.

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A3.4. Procedure A3.6.1.1 Screw Identification—Reference any applicable
A3.4.1 Insertion of the Test Specimen—The bone screws ASTM or ISO standard specification that may apply to the
shall be inserted into the standard material in accordance with specimen. If specifications do not exist, provide head form,
the insertion torque test method, Annex A2. The screws shall thread form, helix angle, major and minor diameter, thread
be inserted at a rate of 3 r/min to a depth of 20 mm. For fully pitch, overall screw length, head and shank length, length of
threaded screws with threaded lengths less than 20 mm, the threaded portion of shank for partially threaded screws, and
insertion depth should be 60 % of the threaded length of the type of screw point.
screw. Partially threaded bone screws should have all threads A3.6.1.2 Screw chemical composition.
inserted into the standard material. A3.6.1.3 Surface finish.
A3.6.1.4 Axial pullout strength (as defined in 3.1.1).
A3.4.2 Axial Pullout Strength of the Test Specimen—The
test block and test block clamp depicted in Annex A2 shall be A3.6.1.5 Grip span.
fixed to the base of the load frame so that the longitudinal axis A3.6.1.6 Insertion depth.
of the screw is aligned with the direction of the applied load. A3.6.1.7 Test block thickness.
The screw’s head shall be placed in the slot of the load fixture A3.6.1.8 Mode of failure.
and seated in the spherical recess. The load fixture shall then be A3.6.1.9 Test Block Material Description—Specification
attached to the load frame. A tensile load shall be applied to the F1839 grade or density. For materials that do not conform to
test specimen at a rate of 5 mm/min until the screw fails or F1839, provide the following information and the appropriate
releases from the test block. Load (newtons) versus load fixture test methods used to determine the properties of the test block
displacement (millimetres) shall be recorded on a data acqui- material:
sition device, noting the maximum load applied and the mode A3.6.1.9.1 Trade name,
of failure (screw shaft, screw threads, or material failure). A3.6.1.9.2 Composition,
A3.5. Calculation or Interpretation of Results A3.6.1.9.3 Density,
A3.6.1.9.4 Tensile strength,
A3.5.1 Axial Pullout Strength—Determine the axial pullout A3.6.1.9.5 Compression strength, and
strength (in Newtons) of the test specimen from the load-
A3.6.1.9.6 Shear strength.
displacement curve. The maximum load is reached during the
test method.
A3.7. Precision and Bias
A3.6. Report A3.7.1 Data establishing the precision and accuracy to be
A3.6.1 Report the following information: 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 the conditions of loading encountered during the test. The
compression load (force) required to engage the self-tapping apparatus shall incorporate a test block clamp for the purpose
feature of self-tapping medical bone screws into a standard of rigidly fixing a test block. The apparatus shall be capable of
material. The results obtained in this test method bear no direct continuously monitoring and recording the force, torque, and
correlation to the axial force required to insert the subject bone axial displacement of the specimen. The apparatus shall be
screw into human or animal bone. This test method is used only calibrated for the range of forces, torques, and linear displace-
to measure the uniformity of the product tested or to compare ments used in the determination.
the performance of different, yet similarly sized, products. This
test method is not applicable to “self-drilling” or “self-drilling/ A4.2.2 Compression Load Cell—A transducer to translate
self-tapping” styles of medical bone screws. the applied axial force into an electrical signal suitable for
continuous recording and calibrated over the range of forces to
A4.2 Apparatus be encountered in the test method, shall be provided. The load
cell should have an accuracy of 0.5 % of full-scale output and
A4.2.1 Testing Apparatus—A schematic for the axial self-
allow measurement resolution of 61.0 N.
tapping force test apparatus is illustrated in Fig. A4.1. The
apparatus shall provide a variable speed motor capable of A4.2.3 Torque Transducer—A transducer to translate the
continuously driving a spindle. The spindle shall be capable of applied torque into an electrical signal suitable for continuous
a continuous rotation as well as axial translation to allow recording and calibrated over the range of torques, both in
variable force on the test specimen. The apparatus and spindle clockwise and counterclockwise rotation, to be encountered in
shall be sufficiently rigid to neither deflect nor deform under the test method, shall be provided. The torque transducer

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shall be drilled straight and true, free of taper, bell mouth, or
barrel shape. The holes should be drilled completely through
the test block and all particulate debris removed prior to
inserting the test specimen. If there are multiple holes in one
test block, the pilot holes shall be spaced sufficiently far away
from test block edges so that testing does not deform test block
edges. Spacing should have a minimum distance as recom-
mended in A2.2.1.8. When the test block is inserted into the
test fixture (Fig. A4.1), the pilot hole, screw, and screwdriver
shall be on the same axis.
A4.2.8 Test Specimen—The test specimen shall be a com-
pletely fabricated and finished bone screw of sufficient length
to allow completion of the test.
A4.2.9 Recorder—The data recorder shall be suitable to
record continuously, at a minimum rate of 10 Hz, axial
compression force, torque, and axial spindle displacement. The
recorder shall be capable of recording two Y axes simultane-
ously (force and torque to Y Axis 1 and displacement to Y Axis
FIG. A4.1 Schematic of Test Apparatus for Determination of Self-
2) versus time (X axis), calibrated in units of Newtons for
Tapping Force force, Newton-metres for torque, and millimetres for displace-
ment. The value of force and torque should have a resolution of
0.5 % of full-scale output and sensitivity so as to enable an
should have an accuracy of 0.5 % of full-scale output and allow accurate recording capability of a minimum of 1.0 N and 0.10
measurement resolution of 60.10 N-m. 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- should have a minimum sensitivity so as to enable an accurate
tions detailed in A4.2.2 and A4.2.3. recording capability for 0.5 mm.
A4.2.4 Linear Displacement Transducer—A transducer to A4.2.10 Test Speed—The torsional force shall be applied at
translate the axial displacement of the test apparatus’s spindle a constant rate of 30 r/min. The axial compression force shall
into an electrical signal suitable for continuous recording and be applied at a constant rate of approximately 2 N/s. The
calibrated over the range of displacements to be encountered in torsional test speed has been selected to represent the clinical
the test method, shall be provided. The displacement trans- situation of hand-driven screws. The axial load rate has been
ducer should have an accuracy of 1 % of full scale and allow selected to allow easy identification and reaction to the unique
a measurement resolution of 60.5 mm. 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

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recorder are monitored simultaneously while the axial force is lined”) axial displacement. When a specimen stalls, the re-
increased at a rate of approximately 2.0 N/s (6 1.0 N/s). The sumption of the increase in axial force at a rate of 2.0 N/s
axial compression force shall continue to be increased until the (61.0 N/s) is acceptable to once again achieve self-tap
self-tapping features of the screw engage the test block as provided: (1) the secondary, maximum axial force is reported
indicated by a marked increase in torque and axial displace- as the “self-tap force”; (2) the specimen completes five
ment as shown in Fig. A4.2. revolutions after the secondary self-tap; and (3) the specimen is
A4.4.3 This unique combination signifies the engagement indicated as “stalled” or “stripped” in the Comments section of
of the self-tapping features of the bone screw into the test the test report. Any specimen that stalls more than once shall be
material and the onset of “self-tap.” At this moment, the considered invalid.
increase in axial force should be discontinued and the load A4.5 Report
level at which self-tap was first noted maintained (that is, “load
A4.5.1 Report the following information for each specimen
and hold”) while simultaneously monitoring the specimen to
tested (all standard units for reporting shall be in SI units):
ensure the continued self-advance into the test block as noted
A4.5.1.1 Screw Identification—Reference any applicable
by the continually increasing torque and axial displacement.
ASTM or ISO specification that may apply to the specimen. If
(Note that in some instances the axial force may decrease at the
specifications do not exist, provide head form, thread form,
onset of self-tap, as shown in Fig. A4.2, indicating self-
major and minor diameter, thread pitch, overall screw length,
advancement of the specimen into the test block without the
head and shank (unthreaded portion of the screw excluding the
need for continuous, applied force. Thus, during this phase of
head) length, and type of screw point.
the test, the axial force serves only to maintain driver-to-screw
A4.5.1.2 Screw chemical composition.
engagement.)
A4.5.1.3 Ultimate tensile strength.
A4.4.4 A total of five complete revolutions should be A4.5.1.4 Surface finish.
achieved after the onset of self-tap to be considered a valid A4.5.1.5 Self-tap force.
specimen. The maximum axial force achieved at the onset of A4.5.1.6 Comments regarding unique testing conditions or
self-tap shall be reported as the “self-tap force.” Values should specimen occurrences.
be reported in Newtons. On occasion, the specimen will A4.5.1.7 Insertion test speed if outside the range specified.
self-tap and then cease advancement into the test block (“stall” A4.5.1.8 Test Block Material Description—Specification
or “strip”) within the first five revolutions, as indicated by a F1839 grade. (Note that Specification F1839 is intended to
rapid loss of torsional resistance and an unchanging (“flat- simulate cancellous bone. However, self-tapping screws must
penetrate cortical bone as well. Therefore, alternative materi-
al(s) may be used to challenge the test specimens provided a
material choice justification is included in the test report.) For
material that does not conform to Specification F1839, provide:
(1) Trade name.
(2) Composition.
(3) Density.
(4) Tensile strength.
(5) Compression strength.
(6) Shear strength.
A4.6 Precision and Bias
A4.6.1 Data establishing the precision and accuracies to be
expected from this test method will be obtained within five
FIG. A4.2 Typical Test Method Output years.

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A5. SPECIFICATIONS FOR HA AND HB METALLIC MEDICAL BONE SCREWS

A5.1 Screw Classification A5.3 Drive Connections

A5.1.1 There are a large variety of medical bone screws A5.3.1 Screws conforming to this specification, and desig-
currently in use. They may be classified by the definitions nated with either the HA or HB classification shall be fabri-
provided in Section 3. 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.
A5.1.1.1 Type HA—Shallow, asymmetrical buttress thread,
A5.3.1.1 Type HA—Hexagonal recess for accepting the
deep screw head, and spherical undersurface of head.
A5.1.1.2 Type HB—Deep, asymmetrical buttress thread, Specification F116 Type IV—Hexagonal bit.
shallow screw head, and spherical undersurface of head. A5.3.1.2 Type HB—Hexagonal recess for accepting the
Specification F116 Type IV—Hexagonal bit.
A5.2 Screw and Thread Form Dimensions
A5.4 Performance Requirements
A5.2.1 There are many types of metallic bone screw designs
available, so a complete list of dimensions and tolerances for A5.4.1 Screws that meet the dimensional requirements of
all screws covered by this specification is unfeasible. This the HA or HB screws in A5.2 shall also meet the following
specification specifies dimensions and tolerances for two types mechanical performance requirements.
of screws that are classified in 4.1. Screws conforming to this A5.4.1.1 Maximum Torque:
specification, and designated with either the HA or HB (1) A minimum of five screws for a particular type and size
classification shall be fabricated in accordance with the dimen-
shall be tested in accordance with the test methods described in
sions and tolerances in this Annex in accordance with the
Annex A1, with five threads exposed in the gage length.
following requirements.
(2) The maximum torque of all screws within the sample of
A5.2.1.1 Type HA:
screws from a particular type and size of screw shall meet or
(1) Screw Dimensions— The dimensions of HA screws are
given in Table A5.1 and Fig. A5.1. exceed the requirements provided in Table A5.5.
(2) Screw Thread— The dimensions of the threads of HA A5.4.1.2 Breaking Angle:
screws are given in Table A5.2 and Fig. A5.2. (1) A minimum of five screws for a particular type and size
A5.2.1.2 Type HB: shall be tested in accordance with the methods described in
(1) Screw Dimensions— The dimensions of HB screws are Annex A1, with five threads exposed in the gage length.
given in Table A5.3 and Fig. A5.3. (2) The breaking angle of all screws within the sample of
(2) Screw Thread— The dimensions of the threads of HB screws from a particular type and size of screw shall meet or
screws are given in Table A5.4 and Fig. A5.4. 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.

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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.

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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.

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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 in the gage
screws are given in Table A6.4 and Fig. A6.4. length exposed.

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

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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

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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
A7.1.1 This annex specifies the requirements for a variety of
drive connections that can be implemented in metallic medical
bone screws. The screw’s drive connection supplies the inter-
connection that is typically used in orthopedic surgery for
inserting and removing bone screws.
A7.1.2 This international standard was developed in accor-
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the FIG. A7.1 Schematic of Screw with Single-Slot Drive Connection
(Table A7.1)
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.

A7.2 Classification
A7.2.1 There are many methods that can be used to classify
medical bone screws. The majority of the methods currently
being used in the medical industry can be found in Section 3 of
this specification. An additional characteristic not covered in
Section 3 is the bone screw’s drive connection. This specifi-
cation describes the following drive connections that are
compatible with the noted screwdriver bits. FIG. A7.2 Schematic of Screw with Cross-Recessed Drive Con-
A7.2.1.1 Single-Slot—This drive connection is illustrated in nection (Table A7.2)
Fig. A7.1. Screws manufactured with this drive connection can
be driven with the Specification F116 Type I—single-slot bit or
the ISO 8319-2 single-slot screwdriver bit. A7.2.1.3 Combined Single-Slot and Cross-Recessed—This
A7.2.1.2 Cross-Recessed—This drive connection is illus- drive connection is illustrated in Fig. A7.3. Screws manufac-
trated in Fig. A7.2. Screws manufactured with this drive tured with this drive connection can be driven with the F116
connection can be driven with the Specification F116 Type Type I—single-slot bit, Specification F116 Type III—cross-slot
III—cross-slot (modified Phillips) bit or the ISO 8319-2 (modified Phillips) bit, the ISO 8319-2 single-slot screwdriver
cross-recessed head screwdriver bit. bit, or the ISO 8319-2 cross-recessed head screwdriver bit.

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

Cross-Recessed Drive Connection (Table A7.3) FIG. A7.5 Schematic of Screw with Combined Cruciate-Slot and
Cross-Recessed Drive Connection (Table A7.5)

A7.2.1.4 Cruciate-Slot—This drive connection is illustrated

in Fig. A7.4. Screws manufactured with this drive connection
can be driven with the Specification F116 Type I—single-slot
bit, Specification F116 Type II—cruciate-slot bit, the ISO
8319-2 single-slot screwdriver bit, or the ISO 8319-2 cruciate-
slot screwdriver bit.
A7.2.1.5 Combined Cruciate-Slot and Cross-Recessed—
This drive connection is illustrated in Fig. A7.5. Screws
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 FIG. A7.6 Schematic of Screw with Hexagonal Drive Connection
(Table A7.6)
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. At this time no standard screwdriver bit is specified
for this drive connection. Screws manufactured with this drive FIG. A7.7 Schematic of Screw with Square Drive Connection
connection can be driven with hexalobe (six-lobe) screwdriver (Table A7.7)
bits that conform to ISO 10664 Standard for Hexobular internal
driving feature for bolts and screws.
A7.3.1.2 Cross-Recessed—The dimensions for this drive
A7.3 Dimensions connection are given in Table A7.2 and Fig. A7.2.
A7.3.1 Medical bone screws conforming to this specifica- A7.3.1.3 Combined Single-Slot and Cross-Recessed—The
tion are as follows: dimensions for this drive connection are given in Table A7.3
A7.3.1.1 Single-Slot—The dimensions for this drive con- and Fig. A7.3. The maximum depth of the recess shall be such
nection are given in Table A7.1 and Fig. A7.1. 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.
A7.3.1.5 Combined Cruciate-Slot and Cross-Recessed—
The dimensions for this drive connection are given in Table
A7.5 and Fig. A7.5. The maximum depth of the recess shall be
such that the torque strength of the screw is unaffected.
A7.3.1.6 Hexagonal—The dimensions for this drive con-
nection are given in Table A7.6 and Fig. A7.6.
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
FIG. A7.4 Schematic of Screw with Cruciate-Slot Drive Connec- the recess shall be such that the torque strength of the screw is
tion (Table A7.4) unaffected.

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FIG. A7.8 Schematic of Screw with Hexalobe Drive Connection (Table A7.8)

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

A7.3.1.8 Hexalobe—The dimensions for this drive connec-

tion are given in Table A7.8 and Fig. A7.8. The maximum
depth of the recess shall be such that the torque strength of the
screw is unaffected.

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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

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

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

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APPENDIX

(Nonmandatory Information)

X1. METALLIC BONE SCREWS

X1.1 This specification is intended to provide useful and X1.4 Performance requirements are provided for two spe-
consistent information related to the performance, terminology, cific types of bone screws. Those that have a solid core and a
requirements for materials, finish and marking considerations, spherical head, specified here as Specification F543 Type HA
and care and handling of metallic bone screws. It includes the and HB, have performance specifications developed from those
terms and requirements of Specification F543-98. This speci- specified in ISO 6475. Standardization of the performance
fication also includes the test methods that were previously requirements and harmonization of these requirements with the
published separately as Specifications F117, F1622, and similar screws described in ISO standards is intended to
F1691.5 facilitate the approval to market for manufacturers declaring
conformity to either or both standards.
X1.2 Materials which have been found acceptable for me-
tallic bone screws includes: X1.5 This specification provides minimum performance
limits for the torsional properties of bone screws and a uniform
X1.2.1 Stainless steel alloy (Specification F138). test procedure by which these limits can be determined. The
X1.2.2 Nitrogen-strengthened stainless steel alloy (Specifi- parameters specified in this specification are breaking torque
cations F1314 and F1586) and breaking angle.
X1.2.3 Unalloyed titanium (Specification F67). X1.5.1 The breaking torque is intended to be a measure of
X1.2.4 Titanium-aluminum-vanadium alloy (Specifications the screw’s strength. Torque was determined to be the critical
F136, F620, and F1472). parameter in the insertion of screws into a uniform medium.
Unpublished test reports indicated that a screw could experi-
X1.2.5 Titanium-aluminum-niobium alloy (Specification ence both torsional and tensile forces when inserted into a
F1295). uniform medium. If the screw was inserted until it ruptured,
X1.2.6 Titanium-niobium-zirconium alloy (Specification then the torsional forces appear to dominate over the tensile
F1713). forces. Therefore, tensile forces were neglected in analyzing
X1.2.7 Cobalt-chromium-molybdenum alloy (Specifica- screw strength.
tions F799 and F1537). X1.5.2 The breaking angle is a measure of the screw’s
X1.2.8 Titanium-molybdenum-zirconium-iron alloy (Speci- ductility. For example, a screw that has a breaking angle of
fication F1813). 360° is more ductile than one with the same design that breaks
at 120° under the same test conditions. Since this parameter
X1.2.9 Titanium-molybdenum-zirconium-iron alloy (Speci- does not represent the point at which the screw loses its elastic
fication F2066). properties, a torsional yield measurement was devised. This
This list is not inclusive of all metallic materials intended for point is intended to present an approximate measure of the
implant applications. It is left to the user of the standard to torque at which the screw loses its elastic properties. The task
justify the application of the material chosen. force decided that an offset method with a 2° angle offset
X1.3 Dimensional requirements are provided for four spe- method was considered to yield the most consistent results.
cific types of bone screws. These screws, specified here as X1.5.3 The breaking force test method provides a consistent
Specification F543 Types HA and HB, HC, and HD are measurement method for fully threaded bone screws. For
dimensionally similar to those specified in ISO 5835 and ISO partially threaded screws, the length of the unthreaded portion
9268. The dimensions and performance of these types of of the screw and the threaded portion can vary considerably
screws are specified because they have achieved widespread among different types of screws. Because of this variation, no
clinical use and are offered by several manufacturers. Stan- exact method of fixation is required. Suggestions are made to
dardization of the dimensions and tolerances of the key grip enough threads to hold the screw in a fixed position with
features of these screws is intended to allow the implants from possibly one or more thread(s) exposed. If this condition is not
one manufacturer to be used with the associated instruments possible, then all threads must be gripped. In any case, the
(taps, drills, and so forth) from different manufacturers and experiment is required to record the gage length and the
serve as a baseline for future screw products. This may benefit gripping length.
the surgeon and patient by aiding the identification of the X1.5.4 If an axial force is necessary to engage the screw-
appropriate instrumentation for the implantation and removal driver in the screw head, the value of this force shall be
of screws by the operating room staff. determined by the operator. The force should be the minimum
needed to engage the screwdriver bit with the screw head.
5
Discontinued; see 2000 Annual Book of ASTM Standards, Vol 13.01. Replaced X1.6 This specification provides a uniform test procedure
May 2001 by Specification and Test Methods F543. for measuring the insertion and removal torque of bone screws

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in a specified medium. This specification can thus provide a 1998 reported differences in the driving torque when sterilized
measure of the uniformity of the products tested or compare the and unsterilized screws were tested.
insertion and removal torque among similar or dissimilar
screws. X1.7 This specification provides a uniform test procedure
for measuring the axial pullout strength of bone screws from a
X1.6.1 The test method specifies that the bone screw be specified medium. This specification can provide a measure of
driven at a rate of 1 to 5 r/min into the test block. The rate the uniformity of the products tested or compare the pullout
specified in the original Test Method F1175 standard was strength among similar or dissimilar screws.
selected and based upon the limitations of torsion test systems
when the standard was originally developed. Faster driving X1.8 During the 2011 periodic review of the standard, the
rates (an order of magnitude greater at 30 r/min) can better subcommittee received comments from members noting that
simulate the clinical situation for hand-driven screws. Specification F543 did not include manufacturing tolerances
Therefore, the user may choose to use higher screw-driving for the dimensions in the specifications for Type V Square and
rates, as long as the selected rate is justified and reported. All Type VI Hexalobe screwdriver connections. The subcommittee
established that there are no published tolerances for the Type
comparative test methods must be performed at the same
V Square connection. However, a standard relevant to Type VI
driving rate.
Hexalobe was identified (ISO 10664) and is included as a
X1.6.2 During the development of this test method, the reference. The subcommittee believes that deletion of the
committee noted the need to test sterilized screws. Infection information on these connections from the standard will detract
Control and Sterilization Technology, V4, No 8 p12, August from the value of the standard as a whole.

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