ISO 15142-2:2003

Overview

ISO 15142-2:2003 - "Implants for surgery - Metal intramedullary nailing systems - Part 2: Locking components" specifies requirements and classification for metallic locking components used with intramedullary nails for temporary stabilization of long bones. The standard applies to all metal intramedullary fixation devices used for temporary fixation in the human body, excluding non-lockable (unlockable) nails. It focuses on the locking elements (screws, bolts, wires, expanding elements, claws, etc.) that control relative motion between nail and bone.

Key topics and technical requirements

• Scope and classification
  • Defines what constitutes a locking component and classifies components as bolts/screws, wires, expanding elements, or other (claws, hooks).
• Materials and biocompatibility
  • Locking components should be manufactured from the same material as the nail, or else biocompatibility must be demonstrated per ISO 10993.
  • A risk assessment per ISO 14971 is required to address corrosion and other hazards; galvanic corrosion effects must be considered if different metals are used.
• Surface requirements
  • Surface finish must not adversely affect biocompatibility and should be assessed in the device risk analysis (see ISO 14602). Surface selection often aims to avoid bone ongrowth that could impede removal.
• Marking and labelling
  • Implants must be marked per ISO 14630; orientation (left/right) must have unique markings to prevent misplacement.
  • Package labelling must include minimum data (e.g., length, diameter) following ISO 14602; material composition should be stated when compatibility with specific nail metallurgy is required.
• Drive connections
  • Screw/bolt locking components are to be inserted/removed with screwdrivers per ISO 8319, using recesses in accordance with ISO 5835. The standard acknowledges compatibility with established ASTM drive/recess designs.

Applications and users

• Medical device manufacturers designing metal intramedullary nails and locking components will use ISO 15142-2 to ensure product consistency, safety, and regulatory readiness.
• Design engineers and R&D teams for orthopedic implants to guide material selection, surface treatment, and mechanical interfaces.
• Regulatory affairs and quality managers for compliance, labelling, and risk management (ISO 14971).
• Test laboratories and certification bodies validating biocompatibility, mechanical fit, and drive interfaces.
• Hospitals and procurement teams referencing standards when specifying implant systems for fracture fixation and temporary long-bone stabilization.

Related standards

• ISO 15142-1 (Intramedullary nails) and ISO 15142-3 (Connection devices and reamer diameter measurements)
• ISO 10993 (Biological evaluation), ISO 14971 (Risk management), ISO 14602 / ISO 14630 (Implant requirements and labelling)
• ISO 5835 (Bone screw dimensions), ISO 8319 (Drive connections)
• ASTM F116 / ASTM F543 (common alternative drive and screw specifications)

ISO 15142-2:2003 is essential for anyone involved in the design, manufacture, testing, and clinical use of metal intramedullary nailing systems and their locking components.