YY/T 0809.2-2020 in English
VALIDImplants for surgery—Partial and total hip joint prostheses—Part 2:Articulating surfaces made of metallic,ceramic and plastics materials
- Issued on:2020-09-27
- Implemented on:2021-09-01
- File Format:PDF
- Delivery:Via email within 1~3 business days
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本标准规定了具有球臼结构的各类全髋和部分髋关节假体关节面的要求，包括：
YY/T 0809.1-2010中分类a）中部分髋关节置换术用金属及陶瓷股骨假体部件的球度及表面粗糙度要求；
YY/T 0809.1-2010中分类a）中连接到股骨部件的塑料内表面和连接到生理髋臼的金属或陶瓷外表面双极股骨头球度及表面粗糙度要求；
YY/T 0809.1-2010中分类b）中塑料髋臼部件的球度及表面粗糙度要求和尺寸公差；
YY/T 0809.1-2010中分类c）中全髋关节假体金属或陶瓷股骨部件的球度及表面粗糙度要求和尺寸公差。
本标准适用于具有球臼结构的各类全髋和部分髋关节假体关节面。
Introduction
Analysis of the core content of the standard
This part of the standard applies to the manufacturing of metal, ceramic and plastic joint surfaces of total hip prostheses and partial hip prostheses, and focuses on standardizing three major categories of technical requirements:
| Technical dimensions | Metal parts | Ceramic parts | Plastic parts |
|---|---|---|---|
| Radial deviation of sphericity | ≤10μm | ≤10μm | ≤100μm |
| Surface roughness Ra | ≤0.05μm | ≤0.02μm | ≤2μm |
| Dimensional tolerance | -0.2~0mm | -0.2~0mm | +0.1~+0.3mm |
Key technology evolution
Compared with the 2010 version of the standard, the 2020 version mainly makes the following technical improvements:
- New definition of spherical vertex (Clause 3.1) clearly defines the measurement benchmark for the intersection of the symmetry axis and the spherical surface
- Strengthening surface roughness detection requires the use of the five-point measurement method specified in GB/T 10610-2009
- Improve radial deviation measurement and specify the partition scanning strategy of the three-dimensional coordinate measuring machine in detail in Appendix A
Application case: ceramic joint surface detection
In accordance with the requirements of Clause 4.1.2, a company used a 0.08mm sampling length to measure the ceramic femoral head, and the Ra values measured at the spherical apex and 30° quadrant were 0.018μm, 0.021μm, 0.019μm, 0.020μm, and 0.017μm, respectively. The average of 0.019μm meets the standard requirement of ≤0.02μm.
Implementation recommendations
- Measurement system verification: It is recommended to use standard balls to calibrate the accuracy of the three-dimensional coordinate measuring machine regularly
- Key points of process control: Plastic parts need to be dimensional tested at 20±2℃ after injection molding
- Documentation requirements: The surface roughness test report should include complete information such as the probe radius and measurement position diagram
Standard system positioning
This part and other standards in the YY/T 0809 series together constitute a complete technical specification system for hip prostheses. Special attention should be paid to the following:
- Part 1 (Classification and Dimensioning) provides basic dimensional references
- Parts 4/6/8 involve fatigue performance tests
- Parts 10/12/13 specify special performance test methods
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