ASTM F116-12(2021)

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

• Status: Published
• Publication Date: 31-Jan-2021
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.21 - Osteosynthesis

Relations

• Refers: ASTM F899-23 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 01-Nov-2023
• Refers: ASTM F899-20 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 01-Feb-2020
• Refers: ASTM F899-19 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 15-Sep-2019
• Refers: ASTM E18-18 - Standard Test Methods for Rockwell Hardness of Metallic Materials
• Effective Date: 01-Jul-2018
• Refers: ASTM E18-17 - Standard Test Methods for Rockwell Hardness of Metallic Materials
• Effective Date: 01-Jul-2017
• Refers: ASTM F1744-96(2016) - Standard Guide for Care and Handling of Stainless Steel Surgical Instruments
• Effective Date: 01-Oct-2016
• Refers: ASTM F565-04(2013) - Standard Practice for Care and Handling of Orthopedic Implants and Instruments
• Effective Date: 01-Oct-2013
• Refers: ASTM F543-13e1 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 01-May-2013
• Refers: ASTM F543-13 - Standard Specification and Test Methods for Metallic Medical Bone Screws
• Effective Date: 01-May-2013
• Refers: ASTM E18-12 - Standard Test Methods for Rockwell Hardness of Metallic Materials
• Effective Date: 01-Dec-2012
• Refers: ASTM F899-12b - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 01-Dec-2012
• Refers: ASTM F899-12a - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 01-Nov-2012
• Refers: ASTM F899-12 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 01-Jun-2012
• Refers: ASTM E18-11 - Standard Test Methods for Rockwell Hardness of Metallic Materials
• Effective Date: 01-Nov-2011
• Refers: ASTM F899-11 - Standard Specification for Wrought Stainless Steels for Surgical Instruments
• Effective Date: 01-Mar-2011

Overview

ASTM F116-12(2021): Standard Specification for Medical Screwdriver Bits establishes the requirements for materials, dimensions, and tolerances for screwdriver bits used in the insertion and removal of metal screws for surgical implants. Developed by ASTM International, this standard outlines six distinct bit types and references critical material and mechanical property requirements to ensure reliable compatibility with surgical procedures involving bone screws. The specification is aligned with international standards supporting safety, performance, and interchangeability in orthopaedic and surgical applications.

Key Topics

• Scope: Defines acceptable materials, dimensions, tolerances, and marking requirements for medical screwdriver bits used in surgery.
• Bit 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
• Material Requirements:
  • Martensitic stainless steel conforming to ASTM F899 or ISO 7153-1
  • Cold worked cobalt-chromium-tungsten-nickel alloy as per ASTM F90 or ISO 5832-5
• Mechanical Properties: Hardness range is specified (measured on Rockwell C scale in line with ASTM E18)
• Marking & Finish: Manufacturer’s identification, size, catalog and lot numbers, and material designation must be clearly marked without compromising screwdriver integrity.
• Care and Handling: Reference to ASTM F565 and ASTM F1744 for maintenance of instruments.
• Dimensional Compatibility: Screwdriver bits are intended for compatibility with screws as specified in ASTM F543, ISO 5835, and ISO 9268.
• Unit Adoption: All values are stated in SI units.

Applications

• Orthopaedic Surgery: Ensures the proper fit between screwdriver bits and bone screws during surgical procedures, improving efficiency and patient outcomes.
• Medical Device Manufacturing: Guides manufacturers in producing tools that meet stringent material and dimensional criteria for use in surgical settings.
• Regulatory Compliance: Facilitates compliance with international material and design standards, supporting worldwide acceptance of medical devices.
• Quality Assurance: Provides clear criteria for hardness and surface finish, helping maintain tool reliability and reducing the risk of surgical complications due to instrument failure.
• Product Marking and Traceability: Requirements for distinct manufacturer and lot markings support traceability and inventory management in healthcare settings.

Related Standards

• ASTM Specifications:

  • ASTM F543: Test methods and requirements for metallic medical bone screws
  • ASTM F899: Stainless steel for surgical instruments
  • ASTM F90: Cobalt-chromium-tungsten-nickel alloy for surgical implants
  • ASTM F565 & F1744: Practice and guide for care and handling of orthopaedic implants and instruments
  • ASTM E18: Rockwell hardness test for metallic materials

• ISO Standards:

  • ISO 5835 & ISO 9268: Surgical implant screws - dimensions and requirements
  • ISO 7153-1: Stainless steel materials for surgical instruments
  • ISO 8319-1 & ISO 8319-2: Drive connections for orthopaedic instruments
  • ISO 10664: Hexalobular internal driving feature for bolts and screws
  • ISO 5832-5: Wrought cobalt-chromium-tungsten-nickel alloy for implants

Practical Value

The adoption of ASTM F116-12(2021) ensures that screwdriver bits used in orthopaedic surgery are manufactured to precise specifications, promoting safe, efficient surgical procedures and supporting global harmonization of medical device standards. Consistency in material quality, marking, and dimensional accuracy minimizes risk and enhances user confidence in surgical instrumentation. For manufacturers, conforming to this standard is instrumental in achieving regulatory approval and market acceptance.

Keywords: medical screwdriver bits, surgical instruments, bone screw, orthopaedic devices, ASTM F116, material requirements, dimensional tolerances, surgical screwdrivers, standard specification

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 [e-mail]. 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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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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