ISO 5838-3:1993

Overview

ISO 5838-3:1993 - Implants for surgery - Skeletal pins and wires - Part 3: Kirschner skeletal wires specifies the dimensional and product-characteristic requirements for Kirschner (K‑) wires used as surgical skeletal implants. The standard covers wire dimensions, tip/end shapes, marking and packaging. Material and mechanical property requirements are handled separately in ISO 5838‑1.

Key topics

• Scope: Defines characteristics for Kirschner skeletal wires (K‑wires) - not material/mechanical properties.
• Dimensions: Prescribes wire diameter and length ranges. Examples from the standard:
  • 0.8 mm < d < 1.3 mm → 70 mm < L < 310 mm
  • 1.4 mm < d < 2.5 mm → 150 mm < L < 310 mm
  • d = 3.0 mm → 150 mm < L < 310 mm
• Tip and end forms: One or both ends may be pointed; trocart-type points have specific angular requirements (illustrated in the standard). Annex A (informative) shows common tip/end variations (e.g., trocart, bayonet, Crowe, drill, Bechtol, Haynes) and notes on hooked or threaded ends.
• Marking and packaging: Packaging and marking must comply with ISO 6018 and include length and diameter in millimetres plus the tip type.
• Informative notes: Allowable options include smooth or threaded hooking ends, manufacturer-specified point/helix angles, and optional designs such as double-pointed wires or a point with a suture hole.

Applications

ISO 5838-3 is intended for practical use where consistent physical specifications for Kirschner wires are required:

• Manufacturers - to design, produce and document K‑wires that meet international dimensional and labeling conventions.
• Quality and regulatory teams - to verify conformity of products during inspection and to support technical files for medical device approvals.
• Procurement and clinical engineering - to specify and purchase K‑wires with clear dimensional and packaging information.
• Testing laboratories - to ensure samples are measured and identified consistently during acceptance or comparative testing.
• Orthopaedic surgeons and hospitals - for clarity about the physical features (length, diameter, tip type) they select for fixation procedures.

Related standards

• ISO 5838‑1 - Implants for surgery - Materials and mechanical properties for skeletal pins and wires.
• ISO 5838‑2 - Steinmann pins - dimensions (other part of the ISO 5838 series).
• ISO 6018 - General requirements for marking, packaging and labelling of orthopaedic implants.

Keywords: ISO 5838-3:1993, Kirschner wires, K‑wires, skeletal pins and wires, implants for surgery, dimensions, marking, packaging, ISO 5838-1, ISO 6018, orthopaedic implants.