ISO 13782:2019

Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications

This document specifies the characteristics of, and corresponding test methods for, unalloyed tantalum sheet, rod and wire used in the manufacture of surgical implants. NOTE 1 Provision is made for two grades of tantalum.

Implants chirurgicaux — Matériaux métalliques — Tantale non allié utilisé dans les implants chirurgicaux

General Information

• Status: Published
• Publication Date: 25-Apr-2019
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150/SC 1 - Materials
• Drafting Committee: ISO/TC 150/SC 1/WG 4 - Metals
• Current Stage: 9092 - International Standard to be revised
• Start Date: 17-Sep-2024
• Completion Date: 13-Dec-2025

Relations

• Revises: ISO 13782:1996 - Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications
• Effective Date: 10-Dec-2016

Overview

ISO 13782:2019 defines the required characteristics and corresponding test methods for unalloyed tantalum used in surgical implants. The standard applies to tantalum supplied as sheet, rod and wire and provides requirements for chemical composition, microstructure and mechanical properties. Two grades are accommodated to reflect different production routes (electron beam or vacuum-arc cast and sintered materials).

Key practical points covered by the standard:

• Material forms: sheet, rod and wire for implant manufacture
• Two grades (RO5200 - electron beam/vacuum-arc cast; RO5400 - sintered)
• Analytical and mechanical test requirements to demonstrate conformity

Key Topics

• Chemical composition: The standard lists limits for major and minor elemental constituents (carbon, oxygen, nitrogen, hydrogen, niobium, iron, titanium, tungsten, molybdenum, silicon, nickel) with tantalum as the balance. Hydrogen analysis is required after final heat and surface treatment.

• Microstructure: The microscopic structure shall be uniform and the grain size shall not be coarser than grain size No. 5 (determined per the referenced method).

• Mechanical properties: Tensile strength, yield or proof strength and percentage elongation after fracture are specified for different forms, diameters and conditions (annealed, stress-relieved, cold-worked). The standard describes retest and acceptance rules for tensile specimens.

• Test methods and sampling: Recognized analytical procedures and specific standards are referenced for test methods. Representative tensile test pieces shall be prepared in accordance with ISO 6892-1; grain size shall be determined by ISO 643.

Applications

ISO 13782:2019 is aimed at manufacturers, material suppliers, design engineers and quality teams involved in the production and qualification of surgical implants where unalloyed tantalum is selected for its corrosion resistance and biocompatibility. Typical application benefits include:

• Consistent material quality for implants (pins, wire-based devices, porous structures made from wire/rod or sheet components)
• Clear acceptance criteria for incoming material inspection and supplier qualification
• Traceable test methods that support regulatory and conformity assessment activities

Related Standards

The document references and relies on established test standards, including:

• ISO 6892-1 - Metallic materials - Tensile testing (preparation and test method for tensile properties)
• ISO 643 - Micrographic determination of apparent grain size

These referenced standards specify the test procedures and specimen preparation required to demonstrate conformity with ISO 13782:2019.

For manufacturers and procurement teams, ISO 13782:2019 provides a concise, practical framework to specify, test and accept unalloyed tantalum materials used in surgical implant applications.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 13782
Second edition
2019-04
Implants for surgery — Metallic
materials — Unalloyed tantalum for
surgical implant applications
Implants chirurgicaux — Produits à base de métaux — Tantale non
allié utilisé dans les implants chirurgicaux
Reference number
©
ISO 2019
© ISO 2019
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ii © ISO 2019 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Chemical composition . 1
5 Microstructure . 2
6 Mechanical properties . 2
7 Test methods . 3
Foreword
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This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee
SC 1, Materials.
This second edition cancels and replaces the first edition (ISO 13782:1996), which has been technically
revised.
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