ASTM F543 - 23

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Designation: F543 −23
Standard Speciﬁcation and Test Methods for
Metallic Medical Bone Screws
1
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
1.1 This speciﬁcation provides requirements for materials,
ﬁnish and marking, care and handling, and the acceptable
dimensions and tolerances for metallic bone screws that are
implanted into bone. The dimensions and tolerances in this
speciﬁcation are applicable only to metallic bone screws
described in this speciﬁcation.
1.2 This speciﬁcation provides performance considerations
and standard test methods for measuring mechanical properties
in torsion of metallic bone screws that are implanted into bone.
These test methods may also be applicable to other screws
besides those whose dimensions and tolerances are speciﬁed
here. The following annexes are included:
1.2.1 Annex A1—Test Method for Determining the Tor-
sional Properties of Metallic Bone Screws.
1.2.2 Annex A2—Test Method for Driving Torque of Medi-
cal Bone Screws.
1.2.3 Annex A3—Test Method for Determining the Axial
Pullout Load of Medical Bone Screws.
1.2.4 Annex A4—Test Method for Determining the Self-
Tapping Performance of Self-Tapping Medical Bone Screws.
1.2.5 Annex A5—Speciﬁcations for Type HA and Type HB
Metallic Bone Screws.
1.2.6 Annex A6—Speciﬁcations for Type HC and Type HD
Metallic Bone Screws.
1.2.7 Annex A7—Speciﬁcations for Metallic Bone Screw
Drive Connections.
1.3 This speciﬁcation is based, in part, upon ISO 5835, ISO
6475, and ISO 9268.
1.4 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
standard.
1.5 Multiple test methods are included in this standard.
However, the user is not necessarily obligated to test using all
of the described methods. Instead, the user should only select,
with justiﬁcation, test methods that are appropriate for a
particular device design. This may only be a subset of the
herein described test methods.
1.6 This standard may involve the use of hazardous
materials, operations, and equipment. This standard does not
purport to address all of the safety concerns, if any, associated
with its use. It is the responsibility of the user of this standard
to establish appropriate safety, health, and environmental
practices and determine the applicability of regulatory limita-
tions prior to use.
1.7 This international standard was developed in accor-
dance with internationally recognized principles on standard-
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom-
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
2. Referenced Documents
2.1 ASTM Standards:
2
E4 Practices for Force Calibration and Veriﬁcation of Test-
ing Machines
E6 Terminology Relating to Methods of Mechanical Testing
E8/E8M Test Methods for Tension Testing of Metallic Ma-
terials
E122 Practice for Calculating Sample Size to Estimate, With
Speciﬁed Precision, the Average for a Characteristic of a
Lot or Process
F67 Speciﬁcation for Unalloyed Titanium, for Surgical Im-
plant Applications (UNS R50250, UNS R50400, UNS
R50550, UNS R50700)
F86 Practice for Surface Preparation and Marking of Metal-
lic Surgical Implants
F116 Speciﬁcation for Medical Screwdriver Bits
F136 Speciﬁcation for Wrought Titanium-6Aluminum-
4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical
Implant Applications (UNS R56401)
F138 Speciﬁcation for Wrought 18Chromium-14Nickel-
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
Implants (UNS S31673)
1
This speciﬁcation is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.21 on Osteosynthesis.
Current edition approved June 1, 2023. Published July 2023. Originally approved
in 1977. Last previous edition approved in 2017 as F543 – 17. DOI: 10.1520/F0543-
23.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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.
1

F565 Practice for Care and Handling of Orthopedic Implants
and Instruments
F620 Speciﬁcation for Titanium Alloy Forgings for Surgical
Implants in the Alpha Plus Beta Condition
F799 Speciﬁcation for Cobalt-28 Chromium-6 Molybdenum
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)
F1537 Speciﬁcation for Wrought Cobalt-28Chromium-
6Molybdenum Alloys for Surgical Implants (UNS
R31537, UNS R31538, and UNS R31539)
F1586 Speciﬁcation for Wrought Nitrogen Strengthened
21Chromium—10Nickel—3Manganese—
2.5Molybdenum Stainless Steel Alloy Bar for Surgical
Implants (UNS S31675)
F1713 Speciﬁcation for Wrought Titanium-13Niobium-
13Zirconium Alloy for Surgical Implant Applications
(UNS R58130) (Withdrawn 0)
3
F1813 Speciﬁcation for Wrought Titanium-12Molybdenum-
6Zirconium-2Iron Alloy for Surgical Implant (UNS
R58120)
F1839 Speciﬁcation for Rigid Polyurethane Foam for Use as
aStandard Material for Testing Orthopaedic Devices and
Instruments
F2066 Speciﬁcation for Wrought Titanium-15 Molybdenum
Alloy for Surgical Implant Applications (UNS R58150)
F2503 Practice for Marking Medical Devices and Other
Items for Safety in the Magnetic Resonance Environment
2.2 ISO Standards:
4
5835 Implants for Surgery—Metal Bone Screws with Hex-
agonal Driver Connection, Spherical Under Surface of
Head, Asymmetrical Thread—Dimensions
6475 Implants for Surgery—Metal Bone Screws with Asym-
metrical Thread and Spherical Under-Surface—
Mechanical Requirements and Test Methods
8319-1 Orthopaedic Instruments—Drive connections—Part
1: Keys for use with hexagon socket heads
8319-2 Orthopaedic Instruments—Drive connections—Part
2: Screwdrivers for single slot head screws, screws with
cruciate and cross-ecessed head screws
9268 Implants for Surgery—Metal Bone Screws with Coni-
cal Under-Surface of Head—Dimensions
10664 Hexalobular Internal Driving Feature for Bolts and
Screws
3. Terminology
3.1 Deﬁnitions—Some of the terms deﬁned in this section
are shown in Fig. 1.
3.1.1 axial pullout load—the tensile force required to fail or
remove a bone screw from a material into which the screw has
been inserted.
3.1.2 breaking angle—angle of rotation when the screw fails
in torsion as demonstrated by a rapid decrease in the indicated
torque.
3.1.3 buttress thread—an asymmetrical thread proﬁle char-
acterized by a pressure ﬂank which is nearly perpendicular to
the screw axis.
3.1.4 cancellous screw—a screw designed primarily to gain
purchase into cancellous bone. Cancellous screws typically
have an HB (see 4.1.2) thread and may or may not be fully
threaded.
3.1.5 cortical screw—a screw designed primarily to gain
biocortical purchase into cortical bone. Cortical screws typi-
cally have a HA (see 4.1.1) thread and are fully threaded.
3.1.6 core diameter—the smallest diameter of the threaded
portion of the screw measured at the thread root. This is also
known as the minor diameter or root diameter.
3.1.7 gage length—the distance between the holding device
(for example, a split collet) and the underside of the screw
head.
3.1.8 grip length—the length of threads held fast in the split
collet or other holding mechanism.
3.1.9 insertion depth—the threaded length as inserted into
the test block.
3.1.10 insertion torque—the amount of torque required to
overcome the frictional force between the screw and the
material used for testing while driving the screw into the
material.
3.1.11 maximum torque (N-m)—the largest value of torque
recorded during the period of rotation before screw failure in
torsional shear when tested in accordance with Annex A1.
3
The last approved version of this historical standard is referenced on
www.astm.org.
4
Available from American National Standards Institute, 25 W. 43rd St., 4th
Floor, New York, NY 10036.
FIG. 1 Schematic of Screw Terms
F543 − 23
2

3.1.12 nontapping screw—a screw that has a tip that does
not contain a ﬂute. Nontapping screws usually require a tap to
be inserted into the pilot hole before the insertion of the screw,
when used in moderate or hard bone.
3.1.13 partially threaded screw—a screw whose threaded
portion does not extend fully from the screw point to the screw
head but instead has a smooth shaft running between the head
and threads.
3.1.14 pilot hole—the hole drilled into the bone into which
the screw tip is inserted. The pilot hole is normally slightly
larger than the screw’s core diameter. However, if the screw is
to be used to provide compression across a fracture, a portion
of the pilot hole may be larger to allow for a clearance ﬁt.
3.1.15 pitch—the length between the thread crests.
3.1.16 removal torque—the amount of torque required to
overcome the frictional force between the screw and the
material used for testing while removing the screw from the
material (for example, counterclockwise rotation for right-hand
thread).
3.1.17 screw head—the end of the screw which is opposite
of the tip and to which the means of inserting the screw is
coupled.
3.1.18 screw length—the overall length of the screw mea-
sured from the screw head to the screw tip.
3.1.19 screw thread—a helical groove on a cylindrical or
conical surface. The projecting helical ridge thus formed is
called a screw thread, consisting of peaks (crests) and valleys
(roots).
3.1.20 self-tapping force (N)—the amount of axial force
required to engage the self-tapping features of self-tapping
style screws when tested in accordance with Annex A4.
3.1.21 self-tapping screw—a screw that has any number of
ﬂutes at its tip which are intended to cut the screw’s thread
form into the bone upon insertion.
3.1.22 size—an identiﬁcation of a screw based on its nomi-
nal thread diameter, as deﬁned in Section 6.
3.1.23 solid core—a screw that does not contain a cannula-
tion along its longitudinal axis.
3.1.24 thread diameter—the largest diameter of the threaded
portion of the screw measured over the thread crests. This is
also known as the major diameter.
3.1.25 thread length—the length of the threaded portion of
the screw, measured from the thread runout to the screw tip.
3.1.26 thread runout—the intersection of the screw thread
with either the screw shaft or screw head.
3.1.27 torsional yield strength (N-m)—the point at which
the screw reaches its proportional limit when tested in accor-
dance with Annex A1. This will be determined by the offset
method. A 2° offset value shall be used.
4. Classiﬁcation
4.1 There are a large variety of medical bone screws
currently in use. They may be classiﬁed by the deﬁnitions
provided in Section 3. This speciﬁcation currently includes
information that deﬁnes the following types of screws:
4.1.1 Type HA—Spherical undersurface of head, shallow,
asymmetrical buttress thread, and deep screw head.
4.1.2 Type HB—Spherical undersurface of head, deep,
asymmetrical buttress thread, and shallow screw head.
4.1.3 Type HC—Conical undersurface of head, symmetrical
thread.
4.1.4 Type HD—Conical undersurface of head, asymmetri-
cal thread.
5. Material
5.1 Screws shall be fabricated from a metallic material
intended for surgical implant applications, and meeting the
requirements for an ASTM medical material. In addition, the
materials shall be biocompatible for the intended application.
6. Dimensions and Tolerances
6.1 There are many types of metallic bone screw designs
available, so a complete list of dimensions and tolerances for
all screws covered by this speciﬁcation is unfeasible. However,
this speciﬁcation does provide required dimensions and toler-
ances for four types of screws as classiﬁed in 4.1. Screws
conforming to this speciﬁcation, and designated HA, HB, HC,
or HD screws, shall be fabricated in accordance with the
dimensions and tolerances described in Annex A5 and Annex
A6.
7. Finish and Marking
7.1 The screw shall be free from nicks, dents, burrs, and
scratches when examined in accordance with Practice F86.
7.2 When size permits, the following information should be
legibly marked on the head of the screw (in order of prefer-
ence):
7.2.1 Manufacturer’s name or logo,
7.2.2 Screw Size—If a screw is manufactured in accordance
with ASTM or ISO speciﬁcations, the ASTM or ISO designa-
tion should be provided,
7.2.3 Material,
7.2.4 Catalog number, and
7.2.5 Manufacturing lot number.
7.3 Screws shall be marked in accordance with Practice
F983, unless otherwise speciﬁed in 7.2, in a manner such that
the mechanical integrity of the screw is not compromised.
8. Care and Handling
8.1 Screws should be cared for and handled in accordance
with Practice F565, as appropriate.
8.2 Consider Practice F2503 to identify potential hazards
produced by interactions between the device and the MR
environment and for terms that may be used to label the device
for safety in the MR environment.
9. Driving Instruments
9.1 A variety of screwdrivers for the insertion and removal
of bone screws exist. The classiﬁcation and dimensions for
various screw-drive recesses currently used in the medical
industry are documented in Annex A7. Speciﬁcation F116
F543 − 23
3

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摘要：

ASTM F543 - 23是ASTM国际标准组织发布的最新版本标准，全称为《外科植入物用金属螺钉的标准规范与测试方法》。该标准详细规定了用于骨科手术中植入人体的金属螺钉（包括自攻螺钉、皮质骨螺钉、松质骨螺钉等）的材料要求、机械性能、表面处理、尺寸公差及标志标识等技术指标，并提供了静态扭转强度、轴向拔出强度、失效扭矩等关键性能的标准化测试方法。标准适用于不锈钢、钛合金、钴铬钼合金等常用植入级金属材料制成的螺钉产品。通过遵循ASTM F543 - 23规范，制造商可以确保螺钉产品在生物相容性、力学

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