top of page
Glossary Term
< Return to Main Navigation

ISO 5832 (Implants for Surgery – Metallic Materials)

Definition

ISO 5832 is an international standard that outlines the requirements for metallic materials used in surgical implants. It provides specifications for composition, mechanical properties, and testing to ensure that these materials are safe, biocompatible, and capable of withstanding the physiological environment over the implant’s lifespan.

Relevance to the MedTech Industry

ISO 5832 ensures that metallic materials used in surgical implants meet stringent safety and performance criteria. It provides manufacturers with a framework for selecting and testing materials to maintain patient safety, optimize implant performance, and achieve regulatory compliance.

Additional Information & Related Terms

Key Sections of ISO 5832

  1. ISO 5832-1 to ISO 5832-17

    • Covers specific metallic materials, including:

      • ISO 5832-1: Wrought stainless steel.

      • ISO 5832-2: Cast cobalt-chromium-molybdenum alloy.

      • ISO 5832-3: Wrought titanium alloy (Ti-6Al-4V).

      • ISO 5832-9: Wrought high nitrogen stainless steel.

      • ISO 5832-11: Forged cobalt-chromium alloy.

      • And others, addressing specific alloys for various surgical applications.

  2. Material Properties

    • Specifies requirements for mechanical strength, corrosion resistance, and surface finish to ensure material durability and compatibility with the human body.

  3. Testing and Validation

    • Provides guidelines for material testing, including chemical composition analysis, mechanical testing (e.g., tensile strength), and corrosion testing.


Examples of Applications

  • Orthopedic Implants: Materials for hip, knee, and spinal implants, such as titanium or cobalt-chromium alloys.

  • Dental Implants: Biocompatible titanium alloys for dental prostheses.

  • Cardiovascular Implants: Metallic stents or heart valve components made from stainless steel or cobalt-chromium alloys.

  • Trauma Fixation Devices: Screws, plates, and rods made from stainless steel or titanium for fracture fixation.

Related Terms

  • Biocompatibility Testing: Ensures that metallic materials conform to ISO 10993 standards for biological safety.

  • Corrosion Testing: A critical evaluation under ISO 5832 to ensure material durability in physiological environments.

  • ISO 10993: A related standard for assessing the biocompatibility of materials used in medical devices.

  • Orthopedic Implants: A major application area for ISO 5832-compliant metallic materials.

bottom of page