YY/T 1772-2021Implants for surgery-Standard test method for conducting and evaluating galvanic corrosion tests in electrolytes (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This standard provides the galvanic corrosion test and evaluation methods for surgical implants, covering sample selection, sample preparation, test environment, and exposure methods.

Formula and characterization of the evaluation method of the test results of the corrosion behavior of the galvanic couple in the electrolyte.

This standard is applicable to characterize the electrical contact state of two or more different metals applied to the human body as surgical implants or parts thereof Corrosion behavior.

This standard does not apply to the evaluation of other forms of corrosion and degradation of surgical implants. This standard also does not apply to the evaluation surface Change of state.

Note 1.The types of devices that may need to be evaluated include overlapping brackets of different alloys, combinations of brackets and bracket markers, and one or more screws in bone plates and screws.

The nail and the rest of the device belong to a combination of different alloys, a multi-component structure made of two or more alloys. For those partially implanted but Devices that have long-term contact with the human body (such as external fixation devices) can also be evaluated using this standard.

Note 2.The effects of other forms of corrosion and degradation of equipment include but are not limited to the following conditions. such as fretting corrosion, crevice corrosion, and any galvanic corrosion on stress The influence of corrosion and corrosion fatigue, etc.

Note 3.The surface state changes include but are not limited to the following conditions. such as (may be caused by the implantation process) scratches or (during the manufacturing process) welding effects.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document. For undated reference documents, the latest version (including all amendments) is applicable to this document.

GB/T 6682 Analytical laboratory water specifications and test methods

YY/T 0695-2008 Standard Test Method for Cyclic Potential Polarization of Corrosion Sensitivity of Small Implanted Devices

YY/T 1552 Surgical Implant Evaluation Method of Open Circuit Potential Measurement for the Long-term Corrosion Behavior of Metal Implant Materials and Medical Devices

3 Significance and application

3.1 Implantable medical devices can be made of different metals, and can also be in electrical contact with different metals, causing galvanic corrosion.

This can lead to the release of corrosion products, which can trigger harmful biological reactions or sacrifice the structural integrity of the device. So measure these plantable The galvanic corrosion susceptibility of the imported device is very important.

3.2 The use of this test method is to provide information on the galvanic components that corrode when two different metals are in contact with each other. Different gold in contact with each other The genus can be on the same implant device, or it can be an independent implant device component.

3.3 This test method is designed to adapt to various device shapes and sizes by using a variety of fixtures.

3.4 This standard is a test method for galvanic corrosion test under simulated physiological environment. Strictly following this test method helps to avoid this Some inherent confusion in class testing.

4 Instruments