Overview
ISO 5838-1:2013 - Implants for surgery - Metallic skeletal pins and wires - Part 1: General requirements defines the baseline requirements for metallic skeletal pins and wires used in bone surgery. It covers materials, mechanical properties, manufacture, finish, sterilization, packaging and manufacturer information (excluding wires intended for binding and twisting).
Key topics and requirements
- Scope and applicability: Applies to metallic skeletal pins and wires for osteosynthesis; excludes binding/twisting wires.
- Materials: Pins and wires must be made from wrought implant-grade materials listed in the ISO 5832 series (stainless steels, titanium and titanium alloys, cobalt‑chromium alloys, etc.).
- Mechanical properties: Minimum tensile strength and elongation requirements are specified (see Table 1 of the standard). Compliance is verified using tensile test methods in ISO 6892-1. Requirements vary by material type and wire/pin diameter.
- Manufacture: Products shall be produced by cold drawing or cold working; welds are not permitted. Local re‑shaping of stainless steel points by heating is allowed only if the final product passes the intergranular corrosion test in ISO 3651-2.
- Surface finish: External surfaces must be free from burs, scratches and visible defects and shall be passivated; special attention is required for threads.
- Sterilization and packaging: Requirements reference ISO 14630 for sterilization and packaging of non‑active surgical implants.
- Information and marking: Instructions for use must include product name, characteristic sizes, material specification and recommended drill bit dimensions. Implant marking should include manufacturer name/trademark and batch code where dimensions permit; length/diameter may also be marked.
Applications and who uses this standard
ISO 5838-1:2013 is used by:
- Medical device manufacturers (design, material selection, production controls and product specifications for Steinmann pins, Kirschner wires and similar implants)
- Quality and regulatory teams ensuring compliance with material, mechanical testing and labeling requirements for surgical implants
- Test laboratories performing tensile and corrosion testing to verify conformity to the standard
- Procurement teams and hospitals that require documented compliance for purchased implants
- Regulatory authorities assessing safety and conformity for orthopedic implants
Related standards
- ISO 5832 series (implant metallic material specifications)
- ISO 6892-1 (tensile testing at room temperature)
- ISO 3651-2 (intergranular corrosion testing of stainless steels)
- ISO 14630 (non‑active surgical implants - general requirements)
Keywords: ISO 5838-1:2013, metallic skeletal pins and wires, implants for surgery, mechanical properties, sterilization, packaging, ISO 5832, ISO 6892-1, ISO 14630.