ASTM F116-00
(Specification)Standard Specification for Medical Screwdriver Bits
Standard Specification for Medical Screwdriver Bits
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.
1.3 The screwdrivers with the bits described in this standard are suitable for use with screws described in F 543, ISO 5835, and ISO 9268.
1.4 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.
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Designation: F 116 – 00
Standard Specification for
Medical Screwdriver Bits
This standard is issued under the fixed designation F 116; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope agonal Driver Connection, Spherical Under Surface of
Head, Asymmetrical Thread—Dimensions
1.1 This specification covers the acceptable dimensions and
7153-1 Surgical Instruments—Metallic Materials—Part 1:
tolerances for bits of screwdrivers to insert and remove metal
Stainless Steel
screws used as surgical implants.
8319-1 Orthopaedic Instruments—Drive Connections—
1.2 This specification is based, in part, upon ISO 8319-1 and
Part 1: Keys for Use with Screws with Hexagon Socket
ISO 8319-2.
Heads
1.3 The screwdrivers with the bits described in this standard
8319-2 Orthopaedic Instruments—Drive Connections
are suitable for use with screws described in F 543, ISO 5835,
—Part 2: Screwdrivers for Single Slot Head Screws,
and ISO 9268.
screws with Cruciate Slot, and Cross-Recessed Head
1.4 This standard does not purport to address all of the
Screws
safety concerns, if any, associated with its use. It is the
9268 Implants for Surgery—Metal Bone Screws with Coni-
responsibility of the user of this standard to establish appro-
cal Under-Surface of Head—Dimensions
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use.
3. Classification
2. Referenced Documents 3.1 This specification includes the following types of bits
for medical screwdrivers:
2.1 ASTM Standards:
3.1.1 Type I—Single-slot bit.
E 18 Standard Test Methods for Rockwell Hardness and
3.1.2 Type II—Cruciate-slot bit.
Rockwell Superficial Hardness of Metallic Materials
3.1.3 Type III—Cross-slot (Modified Phillips) bit.
F 90 Standard Specification for Wrought Cobalt-
3.1.4 Type IV—Hexagonal bit.
Chromium-Tungsten-Nickel Alloy for Surgical Implant
3 3.1.5 Type V—Square bit.
Applications
3.1.6 Type VI—Hexalobe bit.
F 543 Standard Specification and Test Methods for Metallic
Medical Bone Screws
4. Dimensions and Tolerances
F 565 Standard Practice for Care and Handling of Ortho-
3 4.1 Screwdriver bits conforming to this specification shall
paedic Implants and Instruments
be fabricated in accordance with the dimensions and tolerances
F 899 Standard Specification for Stainless Steel Billet, Bar,
3 described below:
and Wire for Surgical Instruments
4.1.1 Type I—Single-slot screwdriver bits must conform to
F 1744 Standard Practice for Care and Handling of Stain-
3 the dimensions and tolerances provided in Table 1, and
less Steel Surgical Instruments
described in Fig. 1.
2.2 ISO Standards:
4.1.2 Type II—Cruciate-slot screwdriver bits must conform
5832-5 Implants for Surgery—Metallic Materials—Part 5:
4 to the dimensions and tolerances provided in Table 2, and
Wrought Cobalt-Chromium-Tungsten-Nickel Alloy
described in Fig. 2.
5835 Implants for Surgery—Metal Bone Screws with Hex-
4.1.3 Type III—Cross-slot (Modified Phillips) screwdriver
bits must conform to the dimensions and tolerances provided in
This specification is under the jurisdiction of ASTM Committee F04 on Fig. 3.
Medical and Surgical Materials and Devices and is the direct responsibility of
4.1.4 Type IV—Hexagonal screwdriver bits must conform to
Subcommittee F04.21on Osteosynthesis.
the dimensions and tolerances provided in Table 3, and
Current edition approved Nov. 10, 2000. Published January 2001. Originally
described in Fig. 4.
published as F 116 – 69. Last previous edition F 116 – 98.
Annual Book of ASTM Standards, Vol 03.01.
4.1.5 Type V—Square screwdriver bits must conform to the
Annual Book of ASTM Standards, Vol 13.01.
dimensions provided in Table 4, and described in Fig. 5.
Available from American National Standards Institute, 11 W. 42nd St., 13th
Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F116
FIG. 1 Dimensions of Single-Slot Screwdriver Bit
TABLE 1 Dimensions and Tolerances of Single-Slot Screwdriver
Bit
Slot Thickness, a Slot Width, b Slot Angle, a
(mm) (mm; maximum) (degrees)
1.10 + 0.03 4.8 5.0 + 308
−0.07 − 308
1.10 + 0.03 5.6 5.0 + 308
−0.07 − 308
FIG. 3 Dimensions and Tolerances of Cross-Slot (Modified
Phillips) Screwdriver Bit
Tungsten-Nickel alloy) when measured on the Rockwell C
scale according to the procedures described in E 18.
5.3 The shaft shall be firmly fixed to a handle of appropriate
material.
FIG. 2 Dimensions of Cruciate-Slot Sc
...
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