ASTM F116-12(2021)
(Specification)Standard Specification for Medical Screwdriver Bits
Standard Specification for Medical Screwdriver Bits
ABSTRACT
This specification covers the acceptable material and dimensional requirements, and tolerances for bits of screwdrivers used for inserting and removing metal screws applied in surgical implants. The medical screwdrivers are available in the following types: Type I—single-slot bit; Type II—cruciate-slot bit; Type III—cross-slot (modified Phillips) bit; Type IV—hexagonal bit; Type V—square bit; Type VI—hexalobe bit. The bit and shaft portion should be fabricated from either martensitic stainless steel or cold worked cobalt-chromium-tungsten-nickel alloy, as specified. The portions should also meet specified values of Rockwell hardness.
SCOPE
1.1 This specification covers the acceptable dimensions and tolerances for bits of screwdrivers to insert and remove metal screws used as surgical implants.
1.2 This specification is based, in part, upon ISO 8319-1, ISO 8319-2, and ISO 10664.
1.3 The screwdrivers with the bits described in this specification are suitable for use with screws described in Specification F543, ISO 5835, 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 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 limitations prior to use.
1.6 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.
General Information
Relations
Standards Content (Sample)
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:F116 −12 (Reapproved 2021)
Standard Specification for
Medical Screwdriver Bits
ThisstandardisissuedunderthefixeddesignationF116;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope F565 PracticeforCareandHandlingofOrthopedicImplants
and Instruments
1.1 This specification covers the acceptable dimensions and
F899 Specification for Wrought Stainless Steels for Surgical
tolerances for bits of screwdrivers to insert and remove metal
Instruments
screws used as surgical implants.
F1744 Guide for Care and Handling of Stainless Steel
1.2 This specification is based, in part, upon ISO 8319-1,
Surgical Instruments
ISO 8319-2, and ISO 10664.
2.2 ISO Standards:
1.3 The screwdrivers with the bits described in this speci-
ISO 5832-5 Implants for Surgery—Metallic Materials—Part
fication are suitable for use with screws described in Specifi-
5: Wrought Cobalt-Chromium-Tungsten-Nickel Alloy
cation F543, ISO 5835, and ISO 9268.
ISO 5835 Implants for Surgery—Metal Bone Screws with
HexagonalDriverConnection,SphericalUnderSurfaceof
1.4 The values stated in SI units are to be regarded as
Head, Asymmetrical Thread—Dimensions
standard. No other units of measurement are included in this
ISO 7153-1 Surgical Instruments—Metallic Materials—Part
standard.
1: Stainless Steel
1.5 This standard does not purport to address all of the
ISO 8319-1 Orthopaedic Instruments—Drive Connections
safety concerns, if any, associated with its use. It is the
—Part 1: Keys for Use with Screws with Hexagon Socket
responsibility of the user of this standard to establish appro-
Heads
priate safety, health, and environmental practices and deter-
ISO 8319-2 Orthopaedic Instruments—Drive Connections
mine the applicability of regulatory limitations prior to use.
—Part 2: Screwdrivers for Single Slot Head Screws,
1.6 This international standard was developed in accor-
screws with Cruciate Slot, and Cross-Recessed Head
dance with internationally recognized principles on standard-
Screws
ization established in the Decision on Principles for the
ISO 9268 Implants for Surgery—Metal Bone Screws with
Development of International Standards, Guides and Recom-
Conical Under-Surface of Head—Dimensions
mendations issued by the World Trade Organization Technical
ISO 10664 Hexalobular Internal Driving Feature for Bolts
Barriers to Trade (TBT) Committee.
and Screws
2. Referenced Documents
3. Classification
2.1 ASTM Standards:
3.1 This specification includes the following types of bits
E18 Test Methods for Rockwell Hardness of Metallic Ma-
for medical screwdrivers:
terials
3.1.1 Type I—Single-slot bit.
F90 Specification for Wrought Cobalt-20Chromium-
3.1.2 Type II—Cruciate-slot bit.
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
3.1.3 Type III—Cross-slot (modified Phillips) bit.
tions (UNS R30605)
3.1.4 Type IV—Hexagonal bit.
F543 Specification and Test Methods for Metallic Medical
3.1.5 Type V—Square bit.
Bone Screws
3.1.6 Type VI—Hexalobe bit.
This specification is under the jurisdiction of ASTM Committee F04 on 4. Dimensions and Tolerances
Medical and Surgical Materials and Devices and is the direct responsibility of
4.1 Screwdriver bits conforming to this specification shall
Subcommittee F04.21 on Osteosynthesis.
Current edition approved Feb. 1, 2021. Published February 2021. Originally be fabricated in accordance with the dimensions and tolerances
approved in 1969. Last previous edition approved in 2016 as F116 – 12 (2016).
described below:
DOI: 10.1520/F0116-12R21.
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 Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
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F116−12 (2021)
FIG. 2Dimensions of Cruciate-Slot Screwdriver Bit
TABLE 2 Dimensions and Tolerances of Cruciate-Slot
Screwdriver Bit
Slot Thickness, a Slot Width, b
FIG. 1Dimensions of Single-Slot Screwdriver Bit
(mm) (mm; maximum)
1.10 +0.03 4.8
−0.07
4.1.1 Type I—Single-slot screwdriver bits shall conform to
1.10 +0.03 5.6
−0.07
the dimensions and tolerances provided in Table 1, and shown
in Fig. 1.
4.1.2 Type II—Cruciate-slot screwdriver bits shall conform
to the dimensions and tolerances provided in Table 2, and
shown in Fig. 2.
4.1.3 Type III—Cross-slot (modified Phillips) screwdriver
bitsshallconformtothedimensionsandtolerancesprovidedin
Fig. 3.
4.1.4 Type IV—Hexagonal screwdriver bits shall conform to
the dimensions and tolerances provided in Table 3, and shown
in Fig. 4.
4.1.5 Type V—Square screwdriver bits shall conform to the
general dimensions provided in Table 4, and shown in Fig. 5.
4.1.6 Type VI—Hexalobe screwdriver bits shall conform to
the general dimensions provided in Table 5, and shown in Fig.
6.
5. Material Requirements
5.1 The bit and shaft portion of the screwdriver should be
f
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