YY/T 0809.10-2022 PDF English
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Implants for surgery - Partial and total hip-joint prostheses - Part 10: Determination of resistance to static load of modular femoral heads
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Implants for surgery. Partial and total hip joint prostheses. Part 10: Determination of resistance to static load of modular femoral heads
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YY/T 0809.10-2022: PDF in English (YYT 0809.10-2022) YY/T 0809.10-2022
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
CCS C 35
Replacing YY/T 0809.10-2014
Implants for surgery - Partial and total hip-joint prostheses -
Part 10: Determination of resistance to static load of
modular femoral heads
(ISO 7206-10:2018, MOD)
ISSUED ON: MAY 18, 2022
IMPLEMENTED ON: JUNE 01, 2023
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
Introduction ... 6
1 Scope ... 8
2 Normative references ... 8
3 Terms and definitions ... 9
4 Principle ... 14
5 Instruments and equipment ... 14
6 Test specimens ... 16
7 Procedure ... 17
8 Test report ... 19
9 Disposal of test specimens ... 19
Foreword
This document was drafted in accordance with the rules provided in GB/T 1.1-2020
Directives for standardization - Part 1: Rules for the structure and drafting of
standardizing documents.
This document is Part 10 of YY/T 0809 Implants for surgery - Partial and total hip-
joint prostheses. The following parts have been issued for YY/T 0809:
-- Part 1: Classification and designation of dimensions;
-- Part 2: Articulating surfaces made of metallic, ceramic and plastics materials;
-- Part 4: Determination of endurance properties and performance of stemmed
femoral components;
-- Part 6: Endurance properties testing and performance requirements of neck region
of stemmed femoral components;
-- Part 8: Endurance performance of stemmed femoral components with application
of torsion;
-- Part 10: Determination of resistance to static load of modular femoral heads;
-- Part 12: Deformation test method for acetabular shells;
-- Part 13: Determination of resistance to torque of head fixation of stemmed femoral
components.
This document replaces YY/T 0809.10-2014, Implants for surgery - Partial and total
hip joint prostheses - Part 10: Determination of resistance to static load of modular
femoral heads. Compared with YY/T 0809.10-2014, in addition to editorial changes,
the main technical changes are as follows:
-- Add terms and definitions: bore (3.1), basic design control (3.5), 3D control
elements (3.6), head/neck conical taper connection (3.10).
-- Modify the hardness requirement of the conical bore assemblies from 150 HBW
~ 200 HBW to a hardness of at least 150 HBW (see 5.1.3; 5.1.3 of the 2014
edition).
-- In YY/T 0809.10-2014, the copper ring load distributing device is optional. In this
Part, the copper ring load distributing device must be used for the static
compression test (see 7.3.1; 6.2.1 of the 2014 edition).
-- Add the requirement for preload, which shall be 0.1% of the maximum force of
the testing machine or between 50 N and 200 N (see 7.3.2).
-- Modify the requirements for pullout speed (see 7.4.2; 6.3.2 of the 2014 edition).
-- Modify part of the content in Figure 2 and Figure 3 (see Figure 2 and Figure 3;
Figure 2 and Figure 3 of the 2014 edition).
-- Delete “Methods for cleaning test specimens” (see Appendix A of the 2014
edition).
-- Delete “If it is not applicable” [see 6.1.2b) and 6.2.2 of the 2014 edition] and “If
the stroke rate is set for the testing machine, the reason and the value of the stroke
rate shall be explained” [see 7d) of the 2014 edition], the loading mode is no
longer preferred to the load control mode.
This document uses the redraft method to revise and adopt ISO 7206-10:2018 Implants
for surgery - Partial and total hip-joint prostheses - Part 10: Determination of
resistance to static load of modular femoral heads. Compared with ISO 7206-10:2018,
the main technical differences are as follows:
-- Adjust the normative references with technical differences to adapt to the technical
conditions of China. The adjustments are concentrated in Clause 2 “Normative
references”. The specific adjustments are as follows:
● Use GB/T 231.1 which modifies and adopts the international standard to replace
ISO 6506-1;
● Use GB/T 10610 which is equivalent to the international standard to replace
ISO 4288;
● Use GB/T 16825.1 which is equivalent to the international standard to replace
ISO 7500-1;
● Use YY/T 0809.1 which is equivalent to the international standard to replace
ISO 7206-1.
-- Change “as shown in Figure 1a)” to “as shown in Figure 1b)” in c) of the “Test
report”, as it is an editorial error in ISO 7206-10:2018.
Please note that some of the contents of this document may involve patents. The issuing
organization of this document is not responsible for identifying patents.
This document was proposed by National Medical Products Administration.
This document shall be under the jurisdiction of the Orthopedic Implants Sub-Technical
Committee of the National Technical Committee on Surgical Implants and Orthopedic
Devices (SAC/TC 110/SC 1).
Drafting organizations of this document: Tianjin Medical Device Quality Supervision
and Inspection Center, Suzhou MicroPort OrthoRecon Co. LTD, National Drug
Implants for surgery - Partial and total hip-joint prostheses -
Part 10: Determination of resistance to static load of
modular femoral heads
1 Scope
This document specifies methods of determining the compressive (fracture) or the
tension (disassembly) loads required, under specific laboratory conditions, to cause
failure of a modular head system.
This document applies to components made of metallic and non-metallic materials,
such as femoral heads of partial or total hip-joint replacements of modular construction
(i.e., a head/neck conical taper connection).
This document excludes methods of examining and reporting the test specimens.
2 Normative references
The following documents are referred to in the text in such a way that some or all of
their content constitutes requirements of this document. For dated references, only the
version corresponding to that date is applicable to this document; for undated references,
the latest version (including all amendments) is applicable to this document.
GB/T 231.1, Metallic materials - Brinell hardness test - Part 1: Test method (GB/T
231.1-2018, ISO 6506-1:2014, MOD)
GB/T 10610, Geometrical product specifications (GPS) - Surface texture: Profile
method - Rules and procedures for the assessment of surface texture (GB/T 10610-
2009, ISO 4288:1996, IDT)
GB/T 16825.1, Metallic materials - Calibration and verification of static uniaxial
testing machines - Part 1: Tension/compression testing machines - Calibration and
verification of the force-measuring system (GB/T 16825.1-2008, ISO 7500-1:2004,
IDT)
YY/T 0809.1, Implants for surgery - Partial and total hip joint prostheses - Part 1:
Classification and designation of dimensions (YY/T 0809.1-2010, ISO 7206-1:2008,
IDT)
It is capable of sustaining expected forces and constructed so that the line of force
application passes through the center of the femoral head and is aligned with the neck
axis as indicated in Figure 5. The design of the fixture used to pull against the head
requires either an opening on one side or a modular design. This fixture shall be
sufficiently rigid to prevent deformation which might apply a bending moment or
torque to the neck.
5.2.3 Neck unit
Comprising a neck and cone of the type to which the head is to be mounted in service,
or a dummy having the same dimensions and being made of the same material, by the
same manufacturing process and to the same specification [see Figure 1 b)]. In cases of
dispute, the test shall be performed using the complete stemmed femoral component.
6 Test specimens
6.1 Manufacture of the cones and bores used in femoral head modularity requires
precision control in order that the cone and bore mate and lock consistently. Basic
design controls include engagement length between the bore and the cone; bore surface
roughness; cone surface roughness; and the three-dimensional (3D) control elements.
The 3D control elements include bore and cone circularity, bore and cone straightness,
cone angle, bore angle, bore and cone concentricity, and bore and cone diameter at a
reference point. Different manufacturers have different ways of controlling and
measuring the basic design controls and 3D control elements they use in the
manufacture of modular head systems. For this test, it is required that these parameters
are always within the manufacturer’s requirements. If the implant manufacturers are
running the tests, all basic design controls and 3D control elements and tolerances
should be reported for the specimens.
6.2 The alignment of the femoral cone and bore axis with the line of force application
is important. If the applied force is not in line with the axis of the cone and the bore, it
can affect the results of the test. It is more difficult to align the cone section of an actual
femoral implant to the line of force application and maintain that alignment under large
forces. It is acceptable to produce a simulated cone that has a flat base that makes that
alignment easier. Those simulated cones shall be fabricated from the same material in
the same metallurgical condition and be produced using the same fabrication methods
as the actual femoral implant. They shall have all the same basic design controls and
3D control elements as actual implants. All basic design controls and 3D control
elements used in the manufacture of test specimens shall be measured and recorded
using the same techniques used in the production of actual implants.
6.3 All heads used in the tests shall be actual implants. The manufacturer shall ensure
that the heads tested have all the same basic design controls and 3D control elements
as actual implants. If tested under the control of the manufacturer, the basic design
controls and 3D control elements for each test head shall be measured and recorded.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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