YY/T 0856-2011Implants for osteosynthesis - Metallic angled fixation devices (English PDF)

1 Scope

This standard is intended for the orthopedic implant surgery using metal angle holder (hereinafter referred to as the angle of the holder) provides a comprehensive reference.

Geometric characteristics and features of this standard to establish a fixed angle on the classification and definition of a consistent approach. This standard also fixed angle

The materials, manufacturing, sterilization, packaging, marking, labeling and instructions for use given standard, for fixed angle in the body associated with its use

Important mechanical properties are also given a standard test methods.

This standard is not intended to be a predetermined angle holder for a specific clinical manifestations of performance levels, due to insufficient knowledge, not yet

Forecast uses the results of its special events in the daily life of the individual patient. Furthermore, the standard does not provide for internal bone fixation system

Specially designed angle fixator.

This standard may not apply to all types of angles holder. From the perspective of specific recommendations to fix the angle and its potential use caution

Consider the applicability of this standard.

Note 1. This standard does not apply to the intramedullary hip screws and other non-plate angle holder.

This standard covers the following test methods to test the mechanical properties of the angle of the holder to.

--- Metal bending angle holder single test method (see Appendix A);

--- Metal holder angle bending fatigue performance test methods (see Appendix B).

Unless a separate statement, this standard adopts the International System of Units (SI).

Note 2. There is no equivalent international standards or equivalent.

2 Normative references

The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein

Member. For undated references, the latest edition (including any amendments) applies to this document.

GB/T 228 metal materials at room temperature tensile test method

GB 4234 stainless steel surgical implants

GB/T 10623 test the mechanical properties of metallic materials term

GB/T 12417.1 active surgical implants bone and joint replacement implants - Part 1. Particular requirements for osteosynthesis implants

GB 23102 surgical implant metal material alloy Ti-6Al-7Nb processing materials

GB/T 24629 Surgical implants orthopedic implants maintenance and operation

JJG139 tension, pressure, and universal testing machine

Determination of the strength and stiffness of YY/T 0342 surgical implant plate bending

Part 9 YY 0605.9 surgical implant metal material. Forged high nitrogen stainless steel

YY/T 0640-2008 active surgical implants General requirements

ISO 5832-2 Implants for surgery metallic materials - Part 2. Titanium (Implantsforsurgery-Metalicmaterials-

Part 2. Unaloyedtitanium)

ISO 5832-3 Implants for surgery - Metallic materials - Part 3. Forged -6Al-4V titanium alloy (Implantsforsurgery-

Metalicmaterials-Part 3. Wroughttitanium6-aluminium4-vanadiumaloy)

ISO 5835 surgical implant hexagonal drive connection, spherical under surface, asymmetrical thread metal bone screw size (Implants forsurgery-Metalicbonescrewswithhexagonaldriveconnection, sphericalunder-surfaceofhead, […]