ASTM F116-12

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 and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 30-Sep-2012
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.21 - Osteosynthesis

Relations

• Replaces: ASTM F116-00(2009) - Standard Specification for Medical Screwdriver Bits
• Effective Date: 01-Oct-2012
• Referred By: ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 01-Oct-2012
• Referred By: ASTM F2502-17 - Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
• Effective Date: 01-Oct-2012

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F116 −12
StandardSpecification for
1
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.
3
1. Scope 2.2 ISO Standards:
ISO 5832–5 Implants for Surgery—Metallic Materials—
1.1 This specification covers the acceptable dimensions and
Part 5: Wrought Cobalt-Chromium-Tungsten-Nickel Al-
tolerances for bits of screwdrivers to insert and remove metal
loy
screws used as surgical implants.
ISO 5835 Implants for Surgery—Metal Bone Screws with
1.2 This specification is based, in part, upon ISO 8319–1,
HexagonalDriverConnection,SphericalUnderSurfaceof
ISO 8319–2, and ISO 10664.
Head, Asymmetrical Thread—Dimensions
ISO 7153–1 Surgical Instruments—Metallic Materials—
1.3 The screwdrivers with the bits described in this speci-
fication are suitable for use with screws described in Specifi- Part 1: Stainless Steel
ISO 8319–1 Orthopaedic Instruments—Drive Connections
cation F543, ISO 5835, and ISO 9268.
—Part 1: Keys for Use with Screws with Hexagon Socket
1.4 The values stated in SI units are to be regarded as
Heads
standard. No other units of measurement are included in this
ISO 8319–2 Orthopaedic Instruments—Drive Connections
standard.
—Part 2: Screwdrivers for Single Slot Head Screws,
1.5 This standard does not purport to address all of the
screws with Cruciate Slot, and Cross-Recessed Head
safety concerns, if any, associated with its use. It is the
Screws
responsibility of the user of this standard to establish appro-
ISO 9268 Implants for Surgery—Metal Bone Screws with
priate safety and health practices and determine the applica-
Conical Under-Surface of Head—Dimensions
bility of regulatory limitations prior to use.
ISO 10664 Hexalobular Internal Driving Feature for Bolts
and Screws
2. Referenced Documents
2
3. Classification
2.1 ASTM Standards:
E18 Test Methods for Rockwell Hardness of Metallic Ma-
3.1 This specification includes the following types of bits
terials
for medical screwdrivers:
F90 Specification for Wrought Cobalt-20Chromium-
3.1.1 Type I—Single-slot bit.
15Tungsten-10NickelAlloy for Surgical ImplantApplica-
3.1.2 Type II—Cruciate-slot bit.
tions (UNS R30605)
3.1.3 Type III—Cross-slot (Modified Phillips) bit.
F543 Specification and Test Methods for Metallic Medical
3.1.4 Type IV—Hexagonal bit.
Bone Screws
3.1.5 Type V—Square bit.
F565 PracticeforCareandHandlingofOrthopedicImplants
3.1.6 Type VI—Hexalobe bit.
and Instruments
4. Dimensions and Tolerances
F899 Specification for Wrought Stainless Steels for Surgical
Instruments
4.1 Screwdriver bits conforming to this specification shall
F1744 Guide for Care and Handling of Stainless Steel
be fabricated in accordance with the dimensions and tolerances
Surgical Instruments
described below:
4.1.1 Type I—Single-slot screwdriver bits shall conform to
1
the dimensions and tolerances provided in Table 1, and shown
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
in Fig. 1.
Subcommittee F04.21 on Osteosynthesis.
4.1.2 Type II—Cruciate-slot screwdriver bits shall conform
Current edition approved Oct. 1, 2012. Published November 2012. Originally
to the dimensions and tolerances provided in Table 2, and
approvedin1969.Lastpreviouseditionapprovedin2009asF116 – 00(2009).DOI:
shown in Fig. 2.
10.1520/F0116-12.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
3
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F116−12
FIG. 1Dimensions of Single-Slot Screwdriver Bit
TABLE 1 Dimensions and Tolerances of Single-Slot Screwdriver
Bit
Slot Thickness, a Slot Width, b Slot Angle, α
(mm) (mm; maximum) (degrees)
1.10 +0.03 4.8 5.0 +30'
−0.07 −30'
1.10 +0.03 5.6 5.0 +30'
−0.07 −30'
FIG. 3Dimensions and Tolerances of Cross-Slot (Modified Phil-
lips) Screwdriver Bit
5.1.2 Cold worked Cobalt-Chromium-Tungsten-Nickel al-
loy (Specification F90 or ISO 5832–5).
5.2 The hardness of the material of the bit and shaft portion
shall be 45–55 (stainless steel) or 45–50 (Cobalt-Chromium-
FIG. 2Dimensions of Cruciate-Slot Screwdriver Bit
Tungsten-Nickel alloy) when measured on the Rockwell C
scal
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F116 − 00 (Reapproved 2009) F116 − 12
Standard Specification for
1
Medical Screwdriver Bits
This standard is issued under the fixed designation F116; 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 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 and ISO 8319–2. 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 and health practices and determine the applicability of regulatory
limitations prior to use.
2. Referenced Documents
2
2.1 ASTM Standards:
E18 Test Methods for Rockwell Hardness of Metallic Materials
F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS
R30605)
F543 Specification and Test Methods for Metallic Medical Bone Screws
F565 Practice for Care and Handling of Orthopedic Implants and Instruments
F899 Specification for Wrought Stainless Steels for Surgical Instruments
F1744 Guide for Care and Handling of Stainless Steel Surgical Instruments
3
2.2 ISO Standards:
ISO 5832–5 Implants for Surgery—Metallic Materials—Part 5: Wrought Cobalt-Chromium-Tungsten-Nickel Alloy
ISO 5835 Implants for Surgery—Metal Bone Screws with Hexagonal Driver Connection, Spherical Under Surface of Head,
Asymmetrical Thread—Dimensions
ISO 7153–1 Surgical Instruments—Metallic Materials—Part 1: Stainless Steel
ISO 8319–1 Orthopaedic Instruments—Drive Connections —Part 1: Keys for Use with Screws with Hexagon Socket Heads
ISO 8319–2 Orthopaedic Instruments—Drive Connections —Part 2: Screwdrivers for Single Slot Head Screws, screws with
Cruciate Slot, and Cross-Recessed Head Screws
ISO 9268 Implants for Surgery—Metal Bone Screws with Conical Under-Surface of Head—Dimensions
ISO 10664 Hexalobular Internal Driving Feature for Bolts and Screws
3. Classification
3.1 This specification includes the following types of bits for medical screwdrivers:
3.1.1 Type I—Single-slot bit.
3.1.2 Type II—Cruciate-slot bit.
3.1.3 Type III—Cross-slot (Modified Phillips) bit.
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 April 1, 2009Oct. 1, 2012. Published April 2009November 2012. Originally approved in 1969. Last previous edition approved in 20042009 as
F116 – 00(2004).(2009). DOI: 10.1520/F0116-00R09.10.1520/F0116-12.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
3
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F116 − 12
3.1.4 Type IV—Hexagonal bit.
3.1.5 Type V—Square bit.
3.1.6 Type VI—Hexalobe bit.
4. Dimensions and Tolerances
4.1 Screwdriver bits conforming to this specification shall be fabricated in accordance with the dimensions and tolerances
described below:
4.1.1 Type I—Single-slot screwdriver bits mustshall conform to the dimensions and tolerances provided in Table 1, and
describedshown in Fig. 1.
4.1.2 Type II—Cruciate-slot screwdriver bits mustshall conform to the dimensions and tolerances provided in Table 2, and
describedshown in Fig. 2.
4.1.3 Type III—Cross-slot (Modified Phillips) screwdriver bits mustshall conform to the dimensions and tolerances provided in
Fig. 3.
4.1.4 Type IV—Hexagonal screwdriver bits mustshall conform to the dimensions and to
...