YY/T 1427-2016Implants for surgery—Test solutions and environmental condition for static and dynamic corrosion tests on implantable materials and medical devices (English PDF)

Foreword

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

This standard uses the translation method equivalent to ISO 16428.:2005 "Surgical implants Implantable materials and medical devices Static and dynamic rot Test solution and conditions for corrosion test ". For ease of use, this standard has been modified as follows.

--- in accordance with the Chinese language used to modify some of the format;

--- to some of the statements applied to international standards to apply to the formulation of our standards;

- In view of the specific definition of "static and dynamic test" in section 3.5 of the original text and the following paragraphs,

Introduction

In many cases, medical devices and materials are tested in a physiological environment, for research, development work, and surgical implants and devices Performance evaluation is very desirable. It is often difficult to apply a physiological stock solution because the medium is rapidly deteriorating.

Application of artificial media is common, but the shortcomings of the composition of the larger differences, the test results are usually not comparable.

This standard specifies the use of isotonic sodium chloride (NaCl) solution as a reproducible basic environmental condition. Because this solution is used for surgery The injection and rinse during surgery contain an ion content similar to that of human body fluids, so the solution is suitable. More importantly, the vast majority The corrosion resistance of metals is very sensitive to chloride ions (Cl-). Therefore, isotonic sodium chloride solution has been widely used in testing medical care instrument.

1 Scope

This standard specifies the standard environmental conditions for the testing of implants for metal materials, surgical implants and medical devices. This test condition is controlled The temperature of the test solution, the temperature, the ventilating environment, the ratio of the sample size to the volume of the solution, and the like to simulate the physiological conditions.

Where necessary, the application of these environmental test conditions can be combined with various static or dynamic tests that are affected by physiological conditions. typical Application of corrosion fatigue test, micro-wear and wear test, conventional electrochemical test.

This standard does not take into account typical joint simulator tests and specific applications in the dental field. Trying to reproduce the body fluid tribological properties of the solution, Such as solutions for abrasion studies, are outside the scope of this standard.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

ISO 3696 Analytical laboratory water specifications and test methods (Waterforanalyticallaboratoryuse-Specification andtestmethods)

Standard Test Method for Cyclic Potentiostatic Polarization of Corrosive Sensitivity for Small Implant Instruments YY/T 0695-2008

3 Terms and definitions

The following terms and definitions apply to this document.