ISO 15142-3:2003

Overview

ISO 15142-3:2003 specifies standards for metal intramedullary nailing systems used in surgical implants, focusing on connection devices and reamer diameter measurements. The standard addresses metallic medical devices designed for the temporary intramedullary stabilization of long bones in the human body by surgical implantation. It provides classification, dimensional requirements, and measurement protocols for devices used to insert, remove, or both insert and remove intramedullary nails. This part excludes drive connections for locking elements, which are covered in ISO 15142-2.

Intramedullary nailing is a critical technique for stabilizing long bone fractures, supporting healing while maintaining structural integrity. ISO 15142-3 ensures compatibility, interchangeability, and safety of connection devices and tools used during surgical procedures involving intramedullary nails.

Key Topics

• Connection Elements: Integral parts of the nail, such as holes, windows, bores, slots, or threads, designed to attach insertion/removal devices. Precise dimensions and classifications ensure secure and reliable connections during surgery.
• Insertion/Removal Devices: External instruments temporarily connected to the nail via connection elements, including driving handles, drill guides, extractor bolts, and hooks. These are classified as:
  • Hook-type connection devices
  • Parallel external thread-type connection devices
• Dimensional Standards:
  • Hook connections follow detailed dimensional criteria outlined in Annex A.
  • Parallel external threads conform typically to ISO 8319, with size designations from M4 to M12.
  • ANSI B1.1 screw thread standards (e.g., 1/4-28, 5/16-24) are also referenced for thread compatibility in Annex B.
• Reamer Diameter Measurement: The reamer diameter must be measured using ring gauges to ensure consistency between the reamer size and the marking on the instrument. This eliminates confusion caused by differing diameter references-reamer diameter, resulting bone hole, or nail size.
• Exclusions: The standard explicitly does not cover drive connections used specifically for locking elements which are detailed in ISO 15142-2.

Applications

• Orthopaedic Surgery: ISO 15142-3:2003 primarily serves orthopaedic surgeons and medical device manufacturers by standardizing the tools and connection elements needed for effective intramedullary nailing in long bone fracture treatments.
• Medical Device Manufacturing: Manufacturers can design implants and surgical tools that meet international requirements for safety, compatibility, and dimensional accuracy.
• Quality Assurance: Hospitals and surgical centers can use these standards to verify that intramedullary nailing systems and instruments comply with recognized mechanical and dimensional specifications, ensuring patient safety and procedural efficiency.
• Clinical Research and Development: This standard supports innovation by providing clear benchmarks for developing new connection devices and reamers compatible with established intramedullary nail systems.

Related Standards

• ISO 15142-1 – Metal intramedullary nailing systems – Part 1: Intramedullary nails
• ISO 15142-2 – Metal intramedullary nailing systems – Part 2: Locking components (drive connections for locking elements)
• ISO 8319 – Orthopaedic instruments – Drive connections (parallel external threads for insertion/removal devices)
• ANSI B1.1 – Unified Inch Screw Threads (UN & UNR thread forms, referenced for screw thread compatibility)

ISO 15142-3:2003 is essential for ensuring standardized practices in intramedullary nailing system connection devices and reamer measurements, promoting interoperability and precision in surgical implant procedures. By adhering to this international standard, manufacturers and surgeons contribute to improved patient outcomes and safety in orthopaedic trauma care.

Keywords: ISO 15142-3, metal intramedullary nailing systems, connection devices, reamer diameter measurement, orthopaedic implants, surgical instruments, intramedullary nails, insertion/removal devices, implant standards, long bone stabilization.