YY/T 1812-2022Characterization of physical and chemical properties of degradable biomedical metallic materials (English PDF)

Foreword

This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules of Standardization Documents" drafted.

Introduction

In clinical applications, non-degradable metal materials may suffer from long-term biocompatibility or require secondary surgical removal. degradable The mechanical properties of polymer materials are relatively low, which limits their use in some fields. Degradable biomedical metal materials have Degradability and excellent mechanical properties are more and more widely used in bone nails, stents, closure clips and other devices.

At present, the relevant standards for metal materials that have been published, such as GB/T 13810, GB 4234, etc., are mostly aimed at non-degradable metal materials. for The product standard for a device in a specific field does not evaluate the physicochemical properties of degradable metal materials and devices. Degradable metal material The prepared device will degrade during use, and with the extension of the implantation time, the metal or additives inside the material will be separated in the form of ions.

Compared with traditional materials, in addition to mechanical properties, we should also pay attention to the evaluation of their safety.

When choosing a degradable metal material, in addition to considering whether the physical and chemical properties of the material are suitable for the purpose of use of the device, it is also necessary to combine its clinical Design the degradation cycle for the intended use of the bed, considering whether the degradation process has the clinically required mechanical properties and the biological safety of the degradation products. Wholeness.

The evaluation of the degradation performance of biodegradable biomedical metal materials includes two approaches, in vitro and in vivo. This document mainly deals with in vitro degradation tests.

The in vivo degradation test may involve more influencing factors, and the specific test protocol design can refer to the applicable principles and contents in this document. Characterization of physicochemical properties of degradable biomedical metal materials

1 Scope

This document specifies the characterization of physical and chemical properties of degradable biomedical metal materials (hereinafter referred to as degradable metal materials). This document applies to degradable biomedical metal materials.

Note. Based on the current market situation, degradable biomedical metal materials mainly include magnesium, iron and zinc metals and their alloys.

2 Normative references

The contents of the following documents constitute essential provisions of this document through normative references in the text. Among them, dated citations documents, only the version corresponding to that date applies to this document; for undated references, the latest edition (including all amendments) applies to this document.

GB/T 6394 Metal Average Grain Size Determination Method

3 Terms and Definitions

The following terms and definitions apply to this document.

4 Requirements