BS ISO 7206-6:2013 pdf free download.Implants for surgery 一Partial and total hip joint prostheses一 Part 6: Endurance properties testing and performance requirements of neck region of stemmed femoral components.
This part of ISO 7206 specifies test methods and the fatigue performance for the endurance properties, under specified laboratory conditions, of neck region of stemmed femoral components of total hip joint prostheses and stemmed femoral components used alone in partial hip joint replacement. This part of ISO 7206 does not cover the investigation of the performance of the head or the neck-head junction. It is applicable to modular and non-modular designs made of metallic or non-metallic materials.
It also specifies the test conditions so that the important parameters that affect the hip femoral components are taken into account and describes how the specimen is set up for testing.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 3696:1987, Water for analytical laboratory use — Specfication and test methods
ISO 4965-1:2012, Metallic materials — Dynamic force calibration for uniaxial fatigue testing — Part 1:
Testing systems
ISO 4965-2:2012, Metallic materials — Dynamic force calibration for uniaxial fatigue testing — Part 2:
Dynamic calibration device (DCD) instrumentation
ISO 7206-1, Implants for surgery — Partial and total hip joint prostheses — Part 1: Classification and designation of dimensions
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 7206-1 and the following apply.
3.1 implantable
condition of a test sample which has received all the machining processes, cleaning, degreasing, and sterilization procedures required prior to implantation
3.2 resection line/level
level prescribed by the manufacturer which, in clinical use of the femoral hip stem, corresponds to the proximal cut of the bone shaft
4 Principle of the test method
The test specimen is embedded in a solid medium. For modular stems, the protruding part of the test specimen is immersed in a fluid test medium. A cyclic load is applied to the head of the test specimen until one of the conditions mentioned in fill occurs.
5 Materials
5.1 Embedding medium, i.e., a casting medium, which shall:
a) not crack or break under the load applied during testing;
b) not exhibit excessive deformation or creep;
c be reproducible in strength and other characteristics.
The media that appear satisfactory are acrylic bone cement (see ISO 5833), filled epoxy casting resin, and liquid metal as an amorphous metal alloy. The media should have a modulus of elasticity between 2 000 N/mm2 and 6 000 N/mm2.
5.2 Fluid test medium, a 9,0 g/l solution of analytical grade sodium chloride (NaCl) in distilled or deionized water of grade 3, as specified in ISO 3696.
6 Apparatus
6.1 Testing machine, has the following characteristics:
a) ability to apply a cyclic load in accordance with Clause 8. at the chosen frequency;
b) tolerance in applied load is not greater than ± 2 % at maximum load applied, as specified in ISO 4965;
c) dynamic loading waveform is sinusoidal at the primary frequency;
d) instrumentation to monitor the values of the maximum and minimum loads and the vertical deflection of the head of the test specimen with an uncertainty lower than ± 0,4 mm to stop the machine if deflection exceeds a prescribed value and to record the corresponding number of cycles or the elapsed time of operation.BS ISO 7206-6 pdf download.