ISO 7206-4:2010 PDF

Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties and performance of stemmed femoral components

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Title (English):

ISO 7206-4:2010

Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties and performance of stemmed femoral components

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 13
Publication date:: June 1, 2010
Edition:: ISO IS 7206 edition 3 version 1
ICS:: 11.040.40

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Description (English):

ISO 7206‑4:2010 specifies a test method for determining the endurance properties of stemmed femoral components of total hip joint prostheses and stemmed femoral components used alone in partial hip joints under specified laboratory conditions. It also defines the conditions of testing so that the important parameters that affect the components are taken into account, and describes how the specimen is set up for testing. Furthermore, ISO 7206‑4:2010 specifies the test parameters and the requirements for the endurance limit of stemmed femoral components tested in accordance with this document. The value of the endurance limit test forces and the corresponding number of load cycles are specified.

Technical details

Technical committee: ISO/TC 150/SC 4 - Bone and joint replacements
SKU: ISO 7206-4:2010

Abstract

Overview

ISO 7206-4:2010 - "Implants for surgery - Partial and total hip joint prostheses - Part 4" prescribes a standardized laboratory fatigue and endurance test for stemmed femoral components (used in total or partial hip prostheses). The standard defines specimen setup, test conditions, required apparatus, environment and the criteria for determining the endurance limit (test force and number of cycles) so that results are reproducible and representative of worst‑case loading.

Key topics and technical requirements

Scope & specimen selection
- Applies to monobloc and modular stemmed femoral components with preformed anteversion/antetorsion or double curvature.
- Test specimens are selected as a batch of six technically equivalent implants; combinations chosen to produce the highest stem stress.
CT distance categorization
- CT = distance between centre of femoral head (C) and most distal point of stem (T). Three categories: CT ≤ 120 mm, 120 < CT ≤ 250 mm, CT > 250 mm. Test orientation and potting depth depend on CT.
Specimen orientation & potting
- Defines stem axis, anteversion rotation, and angles α/β (e.g., α = 10° and β = 9° for most stems; α = 0°, β = 4° for long stems) with ±1° tolerance.
- Potting depth D specified per CT category (e.g., D = 0.66 × CT for short stems; fixed or formula values for other lengths) with ±2 mm tolerance.
Materials & environment
- Embedding media examples: acrylic bone cement (ISO 5833), filled epoxy resin or liquid metal alloy; recommended modulus 2 000–6 000 N/mm².
- Fluid medium for modular stems: 9.0 g/L NaCl in grade‑3 water (ISO 3696), maintained at 37 ± 1 °C and aerated.
Apparatus & test parameters
- Cyclic loading frequency 1–30 Hz, sinusoidal waveform; applied-load error ≤ ±2% (ISO 4965).
- Instrumentation must monitor max/min loads and vertical deflection to ±0.2 mm and stop if deflection limits are exceeded.
Outcome
- Determines endurance limit (maximum cyclic force F_D for prescribed number of cycles N_D). Post‑test examinations are agreed between test lab and submitter (not specified in the standard).

Applications and users

Implant manufacturers: design validation, fatigue performance verification, and regulatory submission evidence.
Test laboratories and third‑party certification bodies: standardized test execution and reporting.
R&D and quality engineers: comparative evaluation of stem designs, materials, modular junctions and potting effects.
Regulatory authorities and notified bodies: objective assessment of mechanical endurance claims for hip prostheses.

Related standards

ISO 7206 series (e.g., Part 1, Part 6, Part 8, Part 10) for dimensions, head/neck testing and torsion/endurance methods.
ISO 3696 (water quality), ISO 4965 (dynamic force calibration), ISO 5833 (bone cement properties).

Keywords: ISO 7206-4, hip prostheses, stemmed femoral components, endurance testing, fatigue testing, implant testing, potting depth, CT distance.

Related standards

Standards mentioned in the description

Abstract

Overview

Key topics and technical requirements

Scope & specimen selection
- Applies to monobloc and modular stemmed femoral components with preformed anteversion/antetorsion or double curvature.
- Test specimens are selected as a batch of six technically equivalent implants; combinations chosen to produce the highest stem stress.
CT distance categorization
- CT = distance between centre of femoral head (C) and most distal point of stem (T). Three categories: CT ≤ 120 mm, 120 < CT ≤ 250 mm, CT > 250 mm. Test orientation and potting depth depend on CT.
Specimen orientation & potting
- Defines stem axis, anteversion rotation, and angles α/β (e.g., α = 10° and β = 9° for most stems; α = 0°, β = 4° for long stems) with ±1° tolerance.
- Potting depth D specified per CT category (e.g., D = 0.66 × CT for short stems; fixed or formula values for other lengths) with ±2 mm tolerance.
Materials & environment
- Embedding media examples: acrylic bone cement (ISO 5833), filled epoxy resin or liquid metal alloy; recommended modulus 2 000–6 000 N/mm².
- Fluid medium for modular stems: 9.0 g/L NaCl in grade‑3 water (ISO 3696), maintained at 37 ± 1 °C and aerated.
Apparatus & test parameters
- Cyclic loading frequency 1–30 Hz, sinusoidal waveform; applied-load error ≤ ±2% (ISO 4965).
- Instrumentation must monitor max/min loads and vertical deflection to ±0.2 mm and stop if deflection limits are exceeded.
Outcome
- Determines endurance limit (maximum cyclic force F_D for prescribed number of cycles N_D). Post‑test examinations are agreed between test lab and submitter (not specified in the standard).

Applications and users

Implant manufacturers: design validation, fatigue performance verification, and regulatory submission evidence.
Test laboratories and third‑party certification bodies: standardized test execution and reporting.
R&D and quality engineers: comparative evaluation of stem designs, materials, modular junctions and potting effects.
Regulatory authorities and notified bodies: objective assessment of mechanical endurance claims for hip prostheses.

Related standards

ISO 7206 series (e.g., Part 1, Part 6, Part 8, Part 10) for dimensions, head/neck testing and torsion/endurance methods.
ISO 3696 (water quality), ISO 4965 (dynamic force calibration), ISO 5833 (bone cement properties).

Keywords: ISO 7206-4, hip prostheses, stemmed femoral components, endurance testing, fatigue testing, implant testing, potting depth, CT distance.

ISO 7206-4:2010 PDF

Technical details

Abstract

Overview

Key topics and technical requirements

Applications and users

Related standards

Related standards

Abstract

Overview

Key topics and technical requirements

Applications and users

Related standards

Related standards

Implants for surgery — Acrylic resin cements

Water for analytical laboratory use. Specification and test methods.

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