ASTM F564-24 PDF

Full title and description

ASTM F564-24 — Standard Specification and Test Methods for Metallic Bone Staples. This standard defines mechanical characterization and test methods for metallic staples used for internal fixation in the musculoskeletal system, including fatigue, pull-out fixation, soft‑tissue fixation, and elastic static bending tests; it does not prescribe specific staple designs and is intended to provide reproducible test methods for comparison and design evaluation.

Abstract

This specification covers the design characterization and mechanical performance testing of metallic bone staples used in orthopaedic fixation. It contains multiple test methods (annexes) for constant‑amplitude bending fatigue, pull‑out fixation strength, soft‑tissue fixation strength, and elastic static bending to determine staple mechanical properties under simulated conditions. Users select the subset of tests appropriate to a given device design.

General information

• Status: Active.
• Publication date: Published as F564‑24 in late 2024 (document active/last updated by ASTM on December 5, 2024; many distributors list publication date as December 1, 2024).
• Publisher: ASTM International.
• ICS / categories: Medical/surgical implants and instruments — osteosynthesis/orthopaedic fixation (commonly classified under ICS 11.040.30 and published in ASTM Book of Standards Vol. 13.01).
• Edition / version: F564‑24 (current edition, replaces F564‑17).
• Number of pages: 12 pages.

Scope

The standard characterizes the design and mechanical function of metallic staples for internal fixation of the musculoskeletal system. It specifies four annexed test methods: A1 — constant amplitude bending fatigue; A2 — pull‑out fixation strength; A3 — soft tissue fixation strength; and A4 — elastic static bending. The standard uses SI units as the reference and advises users to choose only the tests appropriate for a particular device design and application.

Key topics and requirements

• Definitions and intent: test methods to assess staple mechanical performance, not prescriptive design specifications.
• Four primary mechanical test methods: bending fatigue (durability over cycles), pull‑out (fixation in bone substrate), soft‑tissue fixation, and elastic static bending (stiffness/bending response).
• Requirement to report units in SI and to justify selection of applicable test methods for each device variant.
• Use of repeatable fixtures, simulated bone or tissue substrates as specified by the chosen test method to ensure interlaboratory comparability.
• Intended for use in device development, verification, comparison of materials/geometries, and submission/assessment activities where mechanical performance data are required.

Typical use and users

Manufacturers of orthopaedic fixation implants and staples, R&D and mechanical testing laboratories, quality/validation teams, regulatory affairs specialists preparing device performance documentation, and notified bodies or regulatory reviewers use this standard to generate repeatable mechanical data for device development, product comparison, bench testing and regulatory submissions. The standard is also used by academic groups studying fixation mechanics.

Related standards

ASTM F564 is part of a family of osteosynthesis and fixation standards; related ASTM standards include F543 (metallic medical bone screws), F382 (metallic bone plates), F384 (angled fracture fixation devices), and other F04 committee documents covering testing and specifications for orthopaedic implants. The previous edition F564‑17 has been superseded by F564‑24.

Keywords

metallic bone staples, bone fixation, osteosynthesis, fatigue testing, pull‑out strength, soft tissue fixation, elastic bending, orthopaedic implants, ASTM F564, implant performance testing.

FAQ

Q: What is this standard?

A: ASTM F564‑24 is the ASTM International standard titled "Standard Specification and Test Methods for Metallic Bone Staples" that defines test methods and performance characterization for metallic bone staples used in internal fixation.

Q: What does it cover?

A: It covers the mechanical characterization and test methods for metallic bone staples—specifically bending fatigue, pull‑out fixation strength, soft‑tissue fixation strength, and elastic static bending—without prescribing specific staple designs.

Q: Who typically uses it?

A: Orthopaedic implant manufacturers, testing laboratories, R&D and quality engineers, and regulatory professionals use it to generate and evaluate bench mechanical data for staples. Regulatory reviewers may reference results performed to this standard when assessing device performance.

Q: Is it current or superseded?

A: F564‑24 is the current active edition (2024) and replaces the prior F564‑17 edition. ASTM lists the F564‑24 document as active and updated in December 2024.

Q: Is it part of a series?

A: Yes — it is developed under ASTM Committee F04 (Medical and Surgical Materials and Devices), Subcommittee F04.21 (osteosynthesis), and sits alongside related ASTM standards for osteosynthesis devices (e.g., F543, F382, F384). It appears in ASTM's Book of Standards Vol. 13.01.

Q: What are the key keywords?

A: metallic bone staples; fatigue test; pull‑out strength; soft‑tissue fixation; elastic bending; orthopaedic implants; osteosynthesis; ASTM F564.