ISO 13782:2019
(Main)Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications
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
- 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
- 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.
Frequently Asked Questions
ISO 13782:2019 is a standard published by the International Organization for Standardization (ISO). Its full title is "Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications". This standard covers: 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.
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.
ISO 13782:2019 is classified under the following ICS (International Classification for Standards) categories: 11.040.40 - Implants for surgery, prosthetics and orthotics. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 13782:2019 has the following relationships with other standards: It is inter standard links to ISO 13782:1996. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase ISO 13782:2019 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of ISO standards.
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.
Any feedback or questions on this document should be directed to the user’s national standards body. A
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