ASTM RR-F04-1006 1984 PDF

Full title and description

St ASTM RR-F04-1006 1984 — Research Report RR:F04-1006: Interlaboratory study supporting ASTM F0382 (Standard Specification and Test Method for Metallic Bone Plates). The report documents multi-laboratory testing conducted to establish a precision statement for the F0382 test methods.

Abstract

This research report (RR:F04-1006), approved May 29, 1984, summarizes an interlaboratory study carried out by seven laboratories that tested four bone‑plate samples to produce a precision statement for the F0382 metallic bone‑plate test methods (bend and fatigue characterization). It documents test procedures used, laboratory results, statistical analysis of repeatability/reproducibility, and conclusions used to support the F0382 standard.

General information

• Status: Research Report (RR) — approved May 29, 1984; produced to support ASTM F0382 (metallic bone plates).
• Publication date: 1984 (Research Report approved 29 May 1984).
• Publisher: ASTM International (American Society for Testing and Materials).
• ICS / categories: Medical and surgical materials and devices; surgical implants; biomaterials; mechanical test methods for implants (ASTM Committee F04 / Subcommittee F04.21).
• Edition / version: RR:F04-1006 (1984) — research report supporting standard F0382 (later revised as F0382 editions).
• Number of pages: Not specified in the ASTM research‑report summary; the associated F0382 standard editions are typically 11–12 pages.

Scope

The report documents the scope and results of an interlaboratory study specifically designed to establish a precision statement (repeatability and reproducibility) for the F0382 test methods used to characterize metallic bone plates (static bend and bending‑fatigue behavior). It provides the experimental matrix, test setups, measurements taken, statistical treatment of data, and recommendations for the test method precision statements that inform the F0382 standard.

Key topics and requirements

• Interlaboratory test program design for implant mechanical testing (seven laboratories, four samples in the reported study).
• Measurement and reporting procedures for static bend and four‑point bending fatigue tests on metallic bone plates.
• Statistical analysis of repeatability and reproducibility; derivation of precision statements for test methods.
• Recommendations to support or refine the wording and precision clauses in ASTM F0382.

Typical use and users

Primary users are standards committees, test laboratories, device manufacturers (orthopaedic implant designers and manufacturers), regulatory reviewers, and researchers conducting mechanical characterization of metallic bone plates. The report is used to understand expected variability in F0382 test results and to support laboratory accreditation, method validation, and design comparisons among bone plate products.

Related standards

Associated standard: ASTM F0382 (F382) — Standard Specification and Test Method for Metallic Bone Plates (multiple editions and revisions). The report is one of several RR:F04 research reports generated by ASTM Committee F04 (Medical and Surgical Materials and Devices) to support specifications and test methods for surgical implant materials and devices. Other F04 documents and subcommittee outputs (F04.21) are relevant for implant material specifications, test methods for fatigue and transformation temperatures of shape‑memory alloys, and related device tests.

Keywords

RR‑F04‑1006; research report; interlaboratory study; metallic bone plates; ASTM F0382; precision statement; bend test; bending fatigue; implants; surgical fixation; F04.21.

FAQ

Q: What is this standard?

A: This item is a Research Report (RR:F04-1006) produced by ASTM Committee F04 in 1984 to document an interlaboratory study that supports the ASTM standard F0382 (metallic bone plates). It is not itself a specification for design, but a supporting technical report documenting method precision.

Q: What does it cover?

A: It covers the design, execution, and statistical analysis of an interlaboratory test program (seven labs, four samples) intended to establish repeatability and reproducibility (precision) for the F0382 test methods that characterize mechanical performance of metallic bone plates (static bend and bending‑fatigue tests).

Q: Who typically uses it?

A: Test laboratories, implant manufacturers, standards writers, and regulatory reviewers use the report to understand expected variability of F0382 test results, to validate laboratory methods, and to support claims or comparisons of bone‑plate mechanical performance.

Q: Is it current or superseded?

A: The research report is a historical document approved in 1984 and remains a reference for the precision statement it established. The F0382 standard it supports has been maintained and revised subsequently (multiple editions, e.g., F0382‑99, F0382‑17). Users should consult the current F0382 edition for up‑to‑date normative requirements; the RR remains useful as supporting background on precision and interlaboratory performance.

Q: Is it part of a series?

A: Yes — it is one of the RR:F04 series research reports produced by ASTM Committee F04 (Medical and Surgical Materials and Devices) to support standards and test methods (see the committee’s list of RR:F04 research reports).

Q: What are the key keywords?

A: metallic bone plates, bone‑plate testing, F0382, RR:F04‑1006, interlaboratory study, precision statement, bending fatigue, static bend, ASTM F04.21.