YY/T 1806.2-2021Evaluation method for in vitro degradation performance of biomedical materials - Part 2: Mussel adhesive protein (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.

This document is part 2 of YY/T 1806 "Methods for Evaluation of In Vitro Degradation Properties of Biomedical Materials". YY/T 1806 has been released the following parts.

--- Part 1: Degradable polyesters;

--- Part 2: Mussel mucin.

Introduction

Mussel mucin is a high-purity single protein obtained by purification from the byssal glands of marine mussels. Mussel mucin has a It has the characteristics of self-oxidative cross-linking to form polymers, has broad-spectrum adhesion, can form a water-resistant protective film and has good biocompatibility.

The application in the field of medicine is becoming more and more extensive.

Different parts of the human body have different physiological environments, the same biological material in different application environments, its own enzymatic hydrolysis and induced The human immune system responds differently. Studies have shown that the degradation of mussel mucin is mainly enzymatic hydrolysis, and the suitable degradation of mussel mucin is The performance evaluation standard method can promote the performance research and product development of mussel mucin, and can also provide methods for the quality control of related products.

Due to the diversity of dosage forms and indications of mussel mucin products, this document does not give specific test methods applicable to all products. in progress When determining the in vitro degradation test of the product, the method given in this document may be referred to but not limited to the actual situation.

YY/T 1806 aims to establish a method for evaluating the in vitro degradation performance of biomedical materials, and is intended to consist of two parts.

--- Part 1: Degradable polyesters. The purpose is to evaluate the in vitro degradation performance of degradable polyester biomedical materials/devices. price method.

--- Part 2: Mussel mucin. The purpose is to evaluate the in vitro degradation performance of mussel mucin biomedical materials/devices method.

1 Scope

This document specifies a method for evaluating the in vitro degradation performance of mussel mucin materials/devices.

This document is applicable to the evaluation of in vitro degradation performance of mussel mucin materials/devices.

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 16886.12 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials

GB/T 16886.13 Biological Evaluation of Medical Devices Part 13: Qualitative and Quantitative Degradation Products of Polymer Medical Devices

3 Terms and Definitions

The following terms and definitions apply to this document.

4 In vitro degradation test design