ASTM F136 / ISO 5832-3 Medical Implant Titanium

Medical Implant Standard for Ti-6Al-4V ELI (Grade 23) Titanium Alloy for Surgical Implants

Standard Overview

ASTM F136 and ISO 5832-3 are harmonized international medical standards specifying requirements for wrought Ti-6Al-4V ELI (Extra Low Interstitial, Grade 23) titanium alloy intended for surgical implant applications. These two standards are globally recognized as the benchmark for medical implant-grade titanium, setting strict requirements for material purity, biocompatibility, mechanical properties and quality control to ensure safety and reliability for human implantation.

ASTM F136 (published by ASTM International) and ISO 5832-3 (published by International Organization for Standardization) share nearly identical requirements, focusing on extra low interstitial element content to maximize biocompatibility and reduce tissue irritation. BOZE Metal specializes in supplying ASTM F136 / ISO 5832-3 compliant Grade 23 titanium for surgical implant manufacturing.

Standard Scope & Applicable Material

Both standards apply exclusively to Ti-6Al-4V ELI (Grade 23) extra low interstitial titanium alloy, designed specifically for manufacturing surgical implants and other implantable medical devices that require direct contact with human tissue and bone.

• Exclusive Alloy: Ti-6Al-4V ELI (Grade 23) Medical Grade Titanium Alloy

• Product Forms: Medical grade bars, plates, sheets for implant manufacturing

• Key Feature: Extra low interstitial content (O, C, N) for maximum biocompatibility

Key Medical Implant Standard Requirements

• Extremely low interstitial element content (Oxygen ≤ 0.13%, Carbon ≤ 0.08%)

• Strict chemical composition control to ensure optimal biocompatibility

• Superior mechanical properties including high toughness and fatigue resistance

• Mandatory biocompatibility evaluation and non-toxic material verification

• Full material traceability from raw material to finished implant components

• Sterilization compatibility and long-term stability in human body environment

Medical Implant Applications

• Orthopedic Implants: Bone plates, bone screws, joint replacements, spinal implants

• Dental Implants: Dental implant fixtures, abutments, oral surgical components

• Surgical Instruments: Implantable surgical devices and precision surgical tools

• Trauma Implants: Fracture fixation devices and orthopedic trauma components

BOZE Metal Compliance & Service

BOZE Metal produces Grade 23 titanium alloy in full compliance with ASTM F136 and ISO 5832-3 medical standards, operating under strict medical-grade quality management systems. We provide complete medical compliance certificates, biocompatibility test reports and full traceability documentation for all medical implant-grade titanium products.

Our medical grade titanium is suitable for precision implant machining via BOZO CNC-Ti, with specialized processing protocols to maintain material purity and medical standard compliance for implantable medical devices.

Related Pages

Standards | Titanium Grades | Raw Materials | BOZO CNC-Ti Custom Service | Contact Us

BOZO CNC-Ti is a brand of BOZE Metal, specializing in titanium alloy CNC precision machining.