ISO 5838-2:1991

Overview

ISO 5838-2:1991 specifies the dimensional requirements for Steinmann skeletal pins used as surgical implants. Part of the ISO 5838 series on skeletal pins and wires, this document defines the geometric features, allowable forms of pin ends and marking requirements. ISO 5838-2:1991 focuses solely on dimensions (given in millimetres) while materials and mechanical properties are addressed separately in ISO 5838-1.

Key topics and requirements

• Scope: Dimensions for Steinmann-type skeletal pins used in surgical fixation.
• Dimensional references: All sizes and shapes are defined by figure 1 to figure 5 and table 1 to table 3 in the standard (diameters, lengths and key shape features).
• Pin ends:
  • One end must be a point (tip) - a recommended tip profile is illustrated.
  • The opposite end must conform to one of three forms:
    • Form A - plain/rounded
    • Form B - square
    • Form C - triangular
  • The geometry of these end forms is specified in figures 3–5 and tables 2–3.
• Units and notation: All dimensions are in millimetres.
• Packaging and marking: Packaging must state the pin length, diameter, and end form (rounded, square, triangular).
• Design considerations: The standard notes that tip design may need adaptation according to insertion method and bone type (cancellous vs cortical), highlighting practical differences in clinical use.

Applications and who uses it

ISO 5838-2 is intended for professionals involved in the design, manufacture, procurement and regulation of orthopedic implants:

• Orthopedic implant manufacturers - to ensure pins meet internationally accepted dimensional specifications for compatibility with instruments and procedures.
• Medical device designers and engineers - for product drawings, tooling and quality control criteria.
• Regulatory and quality managers - as part of conformity evidence and product documentation.
• Procurement and sterile processing teams - to verify packaging labelling and selection of appropriate pin sizes.
• Orthopedic surgeons and clinical staff - for understanding available pin geometries and expected dimensions when selecting implants.

Related standards

• ISO 5838-1 - Implants for surgery - Skeletal pins and wires - Part 1: Materials and mechanical properties (materials/mechanical requirements complementary to Part 2).
• ISO 5838-3 - Part 3: Kirschner skeletal pins - Dimensions.

Keywords: ISO 5838-2:1991, Steinmann skeletal pins, implants for surgery, skeletal pins and wires, dimensions, surgical implants, ISO 5838-1, pin end forms, packaging marking.