YY/T 1860.1-2024 Active Industry standards-Medicine

YY/T 1860.1-2024 Non-active surgical implants—Implant coating—Part 1:General requirements

Publish Date: 2024-09-29 Implement Date: 2025-10-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1860.1-2024

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2024-09-29

Implement Date: 2025-10-15

Pages: 17 pages

Scope

This document specifies the general requirements for implant coatings used in passive surgical implants, including surface coatings and surface modifications. It defines the requirements related to general coating performance, including chemical composition and phase composition, surface structure, coating coverage integrity, solubility, coating thickness, adhesion strength, wear resistance, porosity and pore size, and surface wettability.
This document applies to surface coatings, which are defined as layers of materials intentionally added to the substrate that exhibit any different properties from the natural surface of the substrate.
This document applies to surface modifications, which refer to the intentional transformation or reconstruction of the surface of the original substrate to form a new surface material, which is composed of the material of the substrate itself and possibly foreign materials, and forms a surface layer with different properties.
Since the relevant characteristics of the coating and the required level of characterization largely depend on the intended application of the implant, the general performance requirements in this document are not intended to cover or replace the provisions of specific application performance standards.
This document does not apply to structural modification surfaces whose sole purpose is to alter the surface roughness or the strength of the raw material.
This document does not apply to natural passivated metal surfaces. Although this document applies to intentionally passivated metal surfaces, mature materials passivated by conventional techniques (such as nitric acid immersion) are generally harmless and can be described in a very basic way.
This document does not apply to implant coatings that use living tissue.
This document does not apply to laminates, i.e., multi-layer composite materials, such as artificial blood vessels composed of different