ISO 16402-2008 PDF

Full title and description

Implants for surgery — Acrylic resin cement — Flexural fatigue testing of acrylic resin cements used in orthopaedics. This International Standard specifies a test procedure for assessing the flexural fatigue behaviour of polymerized acrylic (poly(methacrylic acid ester)) resin cements used as bone cements in orthopaedic implants.

Abstract

ISO 16402:2008 applies to resin cements based on poly(methacrylic acid esters) and specifies the procedure for determining the fatigue behaviour of the polymerized cement (flexural fatigue / bending fatigue testing). The method is intended to characterise fatigue performance (S–N behaviour) of cured bone-cement materials used in orthopaedic applications.

General information

• Status: Published — International Standard (confirmed in ISO systematic review, most recently confirmed in 2024).
• Publication date: Published May 21, 2008 (ISO publication date 2008-05).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.40 — Implants for surgery, prosthetics and orthotics.
• Edition / version: Edition 1 (2008).
• Number of pages: 6 pages (ISO published document pagination). Note: some national/adopted versions (e.g., national sale documents) may show different pagination/format.

Scope

ISO 16402:2008 covers the laboratory determination of flexural (bending) fatigue characteristics of acrylic resin cements intended for use in orthopaedic implants. It applies to polymerized cements based on poly(methacrylic acid esters) and defines the general test arrangement, specimen preparation, conditioning, cyclic loading regimen and the reporting of results used to generate fatigue (S–N) data relevant to clinical performance assessment of bone cements.

Key topics and requirements

• Applicability: resin (acrylic) cements based on poly(methacrylic acid esters) used as bone cements in orthopaedics.
• Test method: quasi‑static bending and flexural fatigue (bending) tests to produce S–N curves and fatigue life information.
• Specimen preparation and dimensions: defined specimen geometry and preparation procedures to ensure reproducible test results (see standard for exact dimensions and machining/curing requirements).
• Test environment and conditioning: tests are performed in physiologically relevant conditions (commonly a liquid bath such as Ringer’s solution at body temperature is used in practice for fatigue testing).
• Loading configuration: bending/four‑point bending arrangements are used to produce controlled flexural stresses during cyclic loading.
• Data and reporting: generation of S–N data (stress versus number of cycles to failure), test conditions, specimen details, environmental conditions and statistical treatment of results are required in test reports.

Typical use and users

Users include medical device manufacturers (orthopaedic implants and bone-cement manufacturers), materials and biomechanical test laboratories, regulatory and conformity assessment bodies evaluating implantable devices, and R&D groups developing or comparing acrylic bone cements. The standard is used to characterise fatigue performance for product development, quality control and comparative assessment.

Related standards

Related documents include other ISO standards in the "Implants for surgery" family and national/adopted variants (for example national adoptions of ISO 16402). Test-method standards for bone cement and biomaterials (and related ASTM methods such as those used for bone‑cement mechanical testing) are commonly cross‑referenced when establishing a full test program.

Keywords

ISO 16402, bone cement, acrylic resin cement, polymethacrylate, flexural fatigue, bending fatigue, S–N curve, four‑point bending, orthopaedics, implants for surgery.

FAQ

Q: What is this standard?

A: ISO 16402:2008 is an ISO International Standard that specifies a flexural fatigue (bending fatigue) test method for acrylic (poly(methacrylic acid ester)) resin cements used in orthopaedic implants.

Q: What does it cover?

A: It covers specimen preparation, test configuration (bending/four‑point bending), cyclic loading procedures and reporting needed to determine fatigue behaviour (S–N data) of polymerized acrylic bone cements under conditions intended to represent physiological loading.

Q: Who typically uses it?

A: Orthopaedic device manufacturers, bone‑cement producers, materials testing labs, researchers and regulators use this standard for product development, comparative testing and for providing fatigue performance data in technical files.

Q: Is it current or superseded?

A: As published in May 2008 (Edition 1), ISO 16402:2008 was reviewed and the publication was confirmed in ISO’s 5‑year review cycle; the ISO record shows the standard was confirmed as current following review in 2024, so this edition remains the current ISO document.

Q: Is it part of a series?

A: It sits within the ISO "Implants for surgery" field (ISO/TC 150/SC 1) and is related by subject matter to other ISO standards covering non‑active surgical implants, materials and test methods for orthopaedic implants; users often consider it alongside other national and international test standards for bone cements and biomaterials.

Q: What are the key keywords?

A: Bone cement, acrylic resin, polymethacrylate, flexural fatigue, bending test, four‑point bending, S–N curve, orthopaedics, implant testing.