ASTM F116-00(2004)

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 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.

General Information

• Status: Historical
• Publication Date: 31-Mar-2004
• 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 - Standard Specification for Medical Screwdriver Bits
• Effective Date: 01-Apr-2004
• Replaced By: ASTM F116-00(2009) - Standard Specification for Medical Screwdriver Bits
• Effective Date: 01-Apr-2009
• Referred By: ASTM F2502-17 - Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
• Effective Date: 01-Apr-2004
• Referred By: ASTM F543-23 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 01-Apr-2004

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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F 116 – 00 (Reapproved 2004)
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 5835 Implants for Surgery—Metal Bone Screws with Hex-
agonal Driver Connection, Spherical Under Surface of
1.1 This specification covers the acceptable dimensions and
Head, Asymmetrical Thread—Dimensions
tolerances for bits of screwdrivers to insert and remove metal
7153-1 Surgical Instruments—Metallic Materials—Part 1:
screws used as surgical implants.
Stainless Steel
1.2 Thisspecificationisbased,inpart,uponISO8319-1and
8319-1 Orthopaedic Instruments—Drive Connections—
ISO 8319-2.
Part 1: Keys for Use with Screws with Hexagon Socket
1.3 The screwdrivers with the bits described in this speci-
Heads
fication are suitable for use with screws described in Specifi-
8319-2 Orthopaedic Instruments—Drive Connections
cation F 543, ISO 5835, and ISO 9268.
—Part 2: Screwdrivers for Single Slot Head Screws,
1.4 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-
9268 Implants for Surgery—Metal Bone Screws with Coni-
priate safety and health practices and determine the applica-
cal Under-Surface of Head—Dimensions
bility of regulatory limitations prior to use.
3. Classification
2. Referenced Documents
3.1 This specification includes the following types of bits
2.1 ASTM Standards:
for medical screwdrivers:
E 18 Test Methods for Rockwell Hardness and Rockwell
3.1.1 Type I—Single-slot bit.
Superficial Hardness of Metallic Materials
3.1.2 Type II—Cruciate-slot bit.
F 90 Specification for Wrought Cobalt-20Chromium-
3.1.3 Type III—Cross-slot (Modified Phillips) bit.
15Tungsten-10Nickel Alloy for Surgical Implant Applica-
3.1.4 Type IV—Hexagonal bit.
tions (UNS R30605)
3.1.5 Type V—Square bit.
F 543 Specification and Test Methods for Metallic Medical
3.1.6 Type VI—Hexalobe bit.
Bone Screws
F 565 Practice for Care and Handling of Orthopedic Im-
4. Dimensions and Tolerances
plants and Instruments
4.1 Screwdriver bits conforming to this specification shall
F 899 Specification for Stainless Steel for Surgical Instru-
be fabricated in accordance with the dimensions and tolerances
ments
described below:
F 1744 Practice for Care and Handling of Stainless Steel
4.1.1 Type I—Single-slot screwdriver bits must conform to
Surgical Instruments
the dimensions and tolerances provided in Table 1, and
2.2 ISO Standards:
described in Fig. 1.
5832-5 Implants for Surgery—Metallic Materials—Part 5:
3 4.1.2 Type II—Cruciate-slot screwdriver bits must conform
Wrought Cobalt-Chromium-Tungsten-Nickel Alloy
to the dimensions and tolerances provided in Table 2, and
described in Fig. 2.
This specification is under the jurisdiction of ASTM Committee F04 on
4.1.3 Type III—Cross-slot (Modified Phillips) screwdriver
Medical and Surgical Materials and Devices and is the direct responsibility of
bitsmustconformtothedimensionsandtolerancesprovidedin
Subcommittee F04.21 on Osteosynthesis.
Fig. 3.
Current edition approved Apr. 1, 2004. Published April 2004. Originally
approved in 1969. Last previous edition approved in 2000 as F 116 – 00. 4.1.4 TypeIV—Hexagonalscrewdriverbitsmustconformto
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
the dimensions and tolerances provided in Table 3, and
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
described in Fig. 4.
Standards volume information, refer to the standard’s Document Summary page on
4.1.5 Type V—Square screwdriver bits must conform to the
the ASTM website.
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
dimensions provided in Table 4, and described in Fig. 5.
4th Floor, New York, NY 10036.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 116 – 00 (2004)
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 Test Methods
E 18.
5.3 The shaft shall be firmly fixed to a handle
...