YY/T 0988.3-2021Coatings of surgical implants - Part 3: Mussel adhesive proteins (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 3 of YY/T 0988 "Surgical Implant Coatings". YY/T 0988 has issued the following parts.

--- Part 1: Cobalt-28 Chromium-6 Molybdenum Powder;

--- Part 2: Titanium and titanium-6-aluminum-4-vanadium alloy powder;

--- Part 3: Mussel mucin material;

--- Part 11: Tensile test methods for calcium phosphate coatings and metal coatings;

--- Part 12: Shear test methods for calcium phosphate coatings and metal coatings;

--- Part 13: Calcium phosphate, metal and calcium phosphate/metal composite coating shear and bending fatigue test methods;

--- Part 14: Stereological evaluation methods for porous coatings;

--- Part 15: Test methods for wear resistance of metallic thermal spray coatings.

Introduction

Surgical implant coating refers to a layer of material that is added to a substrate with properties different from the natural surface of the substrate, or is applied to the surface of the original substrate.

Intentional transformation or reconstruction, the formation of a new surface material. Surgical implant coatings can be made of metals, ceramics, polymers, etc. may affect the performance and safety of the implant.

YY/T 0988 will provide performance requirements and test methods for different coating materials to standardize the quality of coating products.

YY/T 0988 Parts 1 to 10 are performance requirements for different types of coating materials, and Parts 11 to 15 are phase off the test method.

--- Part 1.specifies the requirements for cobalt-28 chromium-6 molybdenum alloy powders used to form coatings on cobalt-28 chromium-6 molybdenum implants, but Not applicable to properties of coatings made from powders.

--- Part 2.specifies the requirements for pure titanium powder and titanium-6 aluminum-4 vanadium alloy powder for forming coatings on titanium alloy implants, But not for the properties of coatings made from powders.

--- Part 3: Specifies the technical requirements and test methods for mussel mucin materials for surgical implant coatings, applicable to mussel-derived of mussel mucin materials for surgical implant coatings. Mussel mucin is a hydrophilic protein that can be A coating is formed on the surface of the therapeutic device, which becomes the indirect contact medium between implant materials and biological macromolecules. Mussel mucin material solidifies to the outside The purpose of forming a surface coating on the implant is to form a protein coating on the surface of the implanted device. Surgical implants can be gold Metals, polymer materials, inorganic materials (such as ceramics), etc.

---Part 4 ~ Part 10 is reserved.

--- Part 11: Provides stretching of calcium phosphate coatings and metal porous coatings overlying dense metal substrates at room temperature experiment method.

--- Part 12: Provides continuous calcium phosphate coatings and metal coating shear tests bonded to dense metal substrates at room temperature test method.

--- Part 13: Provides test methods for the shear and bending fatigue properties of calcium phosphate coatings, porous and non-porous metal coatings, and also contains Test method for determining flexural fatigue properties of metallic coatings covered with calcium phosphate.

--- Part 14: Provides characterization of coating thickness, porosity and average intercept of various porous coatings attached to non-porous substrates Stereoscopic test methods.

1 Scope

This document specifies the technical requirements and test methods for mussel mucin materials for the coating of surgical implants.

This document applies to mussel mucin materials derived from mussels for the coating of surgical implants.

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 14233.1-2008 Test methods for medical infusion, blood transfusion and injection equipment - Part 1: Chemical analysis methods

GB/T 16886.1 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing in Risk Management Process

YY/T 0615.1 Requirements for labelling "sterile" medical devices Part 1: Requirements for terminally sterilized medical devices

YY/T 0615.2 Requirements for Labeling "Sterile" Medical Devices Part 2: Requirements for Aseptically Processed Medical Devices

YY/T 0771.1 Medical Devices of Animal Origin Part 1: Application of Risk Management

YY/T 0771.2 Medical Devices of Animal Origin Part 2: Control of Source, Collection and Disposal

YY/T 0771.3 Medical devices of animal origin - Part 3: Removal and inactivation of viral and transmissible spongiform encephalopathy (TSE) factors confirm Pharmacopoeia of the People's Republic of China (four volumes of the 2020 edition)

3 Terms and Definitions

The following terms and definitions apply to this document.

4 Requirements for materials of animal origin

The mussel mucin material extracted and prepared from animal tissues shall comply with the requirements of YY/T 0771.1, YY/T 0771.2 and YY/T 0771.3 Manage and control.