ASTM F116-12 (2021) PDF

Full title and description

ASTM F116-12(2021) — Standard Specification for Medical Screwdriver Bits. This specification defines acceptable materials, dimensional requirements, tolerances, hardness, and marking/finish guidance for screwdriver bits used to insert and remove metal screws applied in surgical implants. It covers multiple bit types (single‑slot, cruciate, cross‑slot/modified Phillips, hex, square, and hexalobe) and references related ISO and ASTM device standards.

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. Bit and shaft materials, typical Rockwell hardness ranges, dimensional tables and figures for six bit types, and basic finish and marking expectations are specified. The standard is aligned in part with ISO 8319‑1, ISO 8319‑2, and ISO 10664 and is intended for use with screws described in ASTM F543 and corresponding ISO screw standards.

General information

• Status: Active — reapproved/reissued as F116‑12(2021).
• Publication date: Reapproved / current edition recorded in 2021 (designation shown as F116‑12(2021); original F116‑12 dating to 2012 with later reapprovals).
• Publisher: ASTM International.
• ICS / categories: 11.040.30 (Surgical instruments and materials).
• Edition / version: Designation F116‑12, reapproved/issued in 2021 (often cited as F116‑12(2021) or F0116‑12R21).
• Number of pages: 5 pages (concise specification with tables and figures).

Scope

The standard specifies acceptable dimensions and tolerances for screwdriver bits intended to insert and remove metal screws used as surgical implants. It applies to bit geometry (six defined types), materials and heat‑treatment/hardness limits for the bit and shaft portion, and compatibility notes referencing ISO and ASTM screw specifications (e.g., F543, ISO 5835, ISO 9268). Values are given in SI units; safety and regulatory applicability remain the responsibility of the user.

Key topics and requirements

• Defined bit types and geometry: Type I single‑slot, Type II cruciate, Type III cross‑slot (modified Phillips), Type IV hexagonal, Type V square, Type VI hexalobe (with dimension tables and figures).
• Material specification: bit and shaft portions to be fabricated from martensitic stainless steel or cold‑worked cobalt‑chromium‑tungsten‑nickel alloy (per referenced material specifications).
• Hardness requirements: specified Rockwell hardness ranges for stainless steel and cobalt‑chromium alloys for bit/shaft.
• Dimensional tolerances: tabulated tolerances for slot thickness, slot width, slot angle and other critical features for each bit type.
• Compatibility and referencing: intended for use with screws per ASTM F543 and ISO screw standards; partially based on ISO 8319‑1, ISO 8319‑2, and ISO 10664.
• Finish and marking: requirements for bit finish (free of nicks/dents) and guidance for secure shaft attachment to handles and basic marking/identification.

Typical use and users

Used by medical device manufacturers, surgical instrument designers, quality engineers, sterilization and reprocessing teams, purchasing/procurement for hospitals, and regulatory personnel who verify instrument conformance. Primary application is in orthopaedic and trauma surgery where implant screws are installed or removed. Instrument suppliers use the standard to ensure interchangeability and proper fit with implant screws.

Related standards

ISO 8319‑1 and ISO 8319‑2 (manual surgical instrument handles and bits), ISO 10664, ASTM F543 (bone screws), ISO 5835 and ISO 9268 (screw dimensions/compatibility), and ASTM material specifications referenced for alloys (e.g., ASTM F90 for cobalt‑chromium alloys where applicable). These documents are commonly consulted together to ensure full device/instrument compatibility and material conformity.

Keywords

medical screwdriver bits, surgical screwdriver, bone screw, orthopaedic instruments, implant screws, screwdriver bit dimensions, surgical instrument standards, ASTM F116, F543, ISO 8319, ISO 5835

FAQ

Q: What is this standard?

A: ASTM F116‑12(2021) is the ASTM specification that defines geometry, materials, hardness, dimensional tolerances, and basic finish/marking requirements for medical screwdriver bits used with implant screws.

Q: What does it cover?

A: It covers six types of screwdriver bits (single‑slot, cruciate, cross‑slot/modified Phillips, hex, square, hexalobe), the acceptable materials for bit and shaft, Rockwell hardness ranges, dimension tables and tolerances, and guidance on finish and secure attachment of the shaft to a handle. It also references related ISO and ASTM screw standards for compatibility.

Q: Who typically uses it?

A: Instrument manufacturers and designers, orthopaedic device companies, hospital procurement and sterile processing departments, and regulatory/quality personnel who ensure instrument interoperability with implant screws.

Q: Is it current or superseded?

A: The F116‑12 designation has been reapproved and recorded in 2021 as F116‑12(2021) (often shown as F0116‑12R21). Users should confirm with ASTM International for any amendments or later revisions published after 2021.

Q: Is it part of a series?

A: It is a focused specification for screwdriver bits and is commonly used alongside related standards such as ASTM F543 (bone screws) and ISO screw and instrument standards (ISO 8319 series, ISO 5835, ISO 9268) to ensure full compatibility between screws and drivers.

Q: What are the key keywords?

A: Medical screwdriver bits, surgical instruments, bone screw, orthopaedic medical devices, screwdriver dimensions, ASTM F116, surgical implant instrumentation.