ASTM F2887-23 PDF
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St ASTM F2887-23
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Ст ASTM F2887-23
Original standard ASTM F2887-23 in PDF full version. Additional info + preview on request
Full title and description
ASTM F2887-23 — Standard Specification for Total Elbow Prostheses. This specification defines essential material, geometric, and performance-related characteristics for total elbow replacement (TER) and hemi-elbow prostheses intended to restore articulation and motion of the human elbow joint complex. It covers designs for primary and revision implants, including linked and unlinked configurations and components implanted with or without bone cement.
Abstract
ASTM F2887-23 provides a concise specification for total elbow and hemi-elbow prosthetic components. The standard identifies the critical design features, materials, and in‑vivo performance characteristics considered important to successful function and durability of elbow arthroplasty devices. It references applicable material and test standards (for example for cobalt‑chromium and titanium alloys, UHMWPE, and wear/fatigue test methods) and states metric (SI) units as the standard unit system.
General information
- Status: Published / Current
- Publication date: March 1, 2023 (edition F2887-23)
- Publisher: ASTM International
- ICS / categories: 11.180.10 — Aids and adaptations for moving (medical prostheses and orthopaedic devices)
- Edition / version: F2887-23 (current edition; replaces F2887-17)
- Number of pages: 9
Scope
The specification covers total elbow replacement (TER) and hemi‑elbow replacement prostheses used to restore elbow joint motion through humeral, ulnar, and/or radial components. It applies to components intended for primary and revision surgery, linked and non‑linked designs, and implants used with or without bone cement. The document provides required descriptions of materials and prosthesis geometry and defines characteristics judged important to in‑vivo performance; it does not guarantee clinical outcome by mere compliance.
Key topics and requirements
- Definitions and classification of elbow prosthesis types (total vs hemi; linked/semiconstrained vs unlinked).
- Material specifications and references for common implant alloys (cobalt‑chrome, titanium) and bearing polymers (UHMWPE).
- Geometric and dimensional descriptors for humeral, ulnar, and radial components and stem features.
- Design considerations for fixation: cemented and cementless implantation options.
- Performance-related characteristics such as constraint, wear, stem fatigue, and surface finish considerations.
- References to test methods for wear, fatigue, and constraint assessment applicable to elbow prostheses.
- Requirement to use SI units as the standard measurement system in the document.
Typical use and users
ASTM F2887-23 is used by orthopaedic implant manufacturers (design and quality teams), test laboratories performing bench and preclinical testing, regulatory reviewers, clinical engineers, and researchers developing or evaluating elbow prostheses. It is consulted during device design, material selection, regulatory submissions, and premarket testing to align component descriptions and test expectations with recognized consensus practice.
Related standards
The specification is maintained by ASTM Committee F04 (Medical and Surgical Materials and Devices), Subcommittee F04.22 (Arthroplasty), and references many related ASTM standards, for example standards covering implant alloys (cobalt‑chromium and titanium specifications), UHMWPE materials, wear and fatigue test methods, and constraint test methods used for joint prostheses.
Keywords
total elbow prosthesis, elbow arthroplasty, hemi-elbow replacement, TER, linked elbow, unlinked elbow, UHMWPE, cobalt‑chromium, titanium, implant geometry, wear testing, stem fatigue, arthroplasty standards
FAQ
Q: What is this standard?
A: ASTM F2887-23 is the ASTM International standard specification that defines material, geometric, and performance-related characteristics for total elbow and hemi‑elbow prostheses.
Q: What does it cover?
A: It covers component descriptions and attributes for humeral, ulnar, and radial implant parts used in total and hemi elbow replacements, including linked and unlinked designs, cemented and cementless fixation, and references applicable material and test standards. It sets out characteristics important to in‑vivo performance but does not certify clinical outcomes.
Q: Who typically uses it?
A: Implant manufacturers, design and QA engineers, preclinical test laboratories, regulatory reviewers, and clinical researchers use this standard when designing, testing, and evaluating elbow arthroplasty devices.
Q: Is it current or superseded?
A: F2887-23 is the current edition published/approved in 2023 and supersedes the prior edition F2887-17 (2017).
Q: Is it part of a series?
A: It is part of the ASTM F04 portfolio of medical and surgical materials and devices standards (subcommittee F04.22 on Arthroplasty). It is related to other joint and implant standards covering materials, bearing polymers, and test methods for hip, knee, shoulder, and other arthroplasty devices.
Q: What are the key keywords?
A: Total elbow prosthesis, hemi-elbow, arthroplasty, linked/semiconstrained, unlinked, UHMWPE, cobalt‑chromium, titanium, wear testing, stem fatigue.