ASTM F560-22 PDF
Name in English:
St ASTM F560-22
Name in Russian:
Ст ASTM F560-22
Original standard ASTM F560-22 in PDF full version. Additional info + preview on request
Full title and description
Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400). Specifies chemical, mechanical, metallurgical, dimensional, and testing requirements for unalloyed tantalum supplied as plate, sheet, strip, bar, and wire intended for use in surgical implant manufacturing.
Abstract
ASTM F560-22 establishes acceptance criteria and test methods for unalloyed tantalum materials used in surgical implants. The standard covers permitted chemical composition (including trace/impurity limits), mechanical properties and tensile testing, microstructural requirements, product forms and dimensions, sampling and lot definitions, certification and ordering information, and references to relevant test standards. The 2022 revision consolidates prior editions and includes updated compositional and quality requirements relevant to medical device manufacture.
General information
- Status: Published / Active
- Publication date: February 15, 2022
- Publisher: ASTM International
- ICS / categories: 11.040.40 (Implants for surgery, prosthetics and orthotics); Medical and surgical materials and devices
- Edition / version: F560-22 (current edition approved Feb 15, 2022)
- Number of pages: 5 (concise specification)
Scope
The specification applies to unalloyed tantalum in the forms of plate, sheet, strip, bar, and wire intended for manufacturing surgical implants. It defines chemical composition limits (for UNS R05200 and UNS R05400), mechanical property requirements and test methods, acceptable product forms and dimensions, metallurgical and microstructural expectations, sampling and lot definitions, and required certificates and ordering information. Values are given in SI or inch‑pound units (each system treated independently).
Key topics and requirements
- Chemical composition limits for unalloyed tantalum (UNS R05200, UNS R05400), including specified limits for impurities and trace elements.
- Mechanical property requirements (tensile strength, yield, elongation) and referenced tensile test procedures (e.g., ISO 6892 / equivalent).
- Metallurgical and microstructural acceptance—requirements for cleanliness, voids, and relevant microstructure for implant use.
- Defined product forms and dimensional ranges: plate, sheet, strip, bar, and wire with size and cross‑section allowances.
- Sampling, lot definition, and acceptance criteria for chemical and mechanical testing.
- Ordering information and certification requirements (material form, condition, units for certification, special tests).
- Reference to related standards and test methods (tensile testing, quality management, implant-specific metallic material standards).
- Notable 2022 revision items: updates to compositional reporting and impurity limits (the 2022 edition introduced or clarified limits for certain trace elements relevant to implant safety and analysis practices).
Typical use and users
Used by medical device OEMs, implant material suppliers, metallurgists, QA/RA teams, contract manufacturers, and testing laboratories. Typical applications include orthopedic, dental, and other implantable devices where tantalum's biocompatibility, corrosion resistance, and mechanical properties are required. The standard is consulted during material specification, procurement, incoming inspection, supplier qualification, and regulatory product submissions.
Related standards
Standards and documents commonly referenced with F560-22 include ISO 13782 (implants — unalloyed tantalum guidance and requirements), ISO 6892 (tensile testing of metallic materials), applicable ASTM implant material specifications (for example ASTM F136, ASTM F138 for other implant alloys), and relevant ISO/ASTM quality and testing practices. UNS material designations R05200 and R05400 are used to identify the grades covered.
Keywords
tantalum; unalloyed tantalum; surgical implants; UNS R05200; UNS R05400; implant materials; medical metallurgy; ASTM F560-22; chemical composition; tensile test; biocompatibility; implant-grade metal
FAQ
Q: What is this standard?
A: ASTM F560-22 is a material specification that defines chemical, mechanical, and metallurgical requirements for unalloyed tantalum intended for surgical implant applications.
Q: What does it cover?
A: It covers composition limits, mechanical property requirements and test methods, product forms (plate, sheet, strip, bar, wire), dimensional and condition guidance, sampling and acceptance, ordering and certification information, and referenced test standards applicable to implant manufacturing.
Q: Who typically uses it?
A: Medical device manufacturers, implant material suppliers, metallurgists, testing laboratories, procurement and quality/regulatory teams involved with implantable devices use this specification to select and verify implant-grade tantalum.
Q: Is it current or superseded?
A: The F560-22 edition was approved February 15, 2022 and is the current ASTM edition as published in 2022. Users should confirm whether any later revisions or amendments have been published after that date when preparing specifications or regulatory submissions.
Q: Is it part of a series?
A: F560 is part of the ASTM F04 committee's suite of standards for medical and surgical materials and devices. It is used alongside other implant material specifications (for example ASTM F136, F138) and related ISO standards covering metallic implant materials and test methods.
Q: What are the key keywords?
A: Key keywords include tantalum, unalloyed tantalum, surgical implants, UNS R05200, UNS R05400, implant material specification, ASTM F560-22, chemical composition, tensile testing, biocompatibility.