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

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Scope

This document specifies the general requirements for implant coatings, including surface
coatings and surface modification, used for non-active surgical implants. This document
specifies the requirements related to generic coating properties, including chemical composition
and phase composition, surface texture, coating coverage integrity, dissolvability, coating
thickness, adhesion strength, abrasion resistance, porosity and pore size, and surface wettability.
This document applies to surface coatings, which are defined as layers of material intentionally
added to a substrate that have any properties different from those of the substrate’s natural
surface.
This document applies to surface modification, which is the intentional transformation or re-
construction of the surface of the original substrate to form a new surface material composed
of the substrate’s own material and possible foreign materials, and to form a surface layer with
different properties.
Since the correlated characteristics of the coatings and the required level of characterization
depend largely on the intended application of the implant, the generic properties of the general
requirements in this document are not intended to override or replace the provisions of specific
application property standards.
This document does not apply to structurally modified surfaces with the sole purpose of
changing the surface roughness or raw material strength.
This document does not apply to naturally passivated metal surfaces. Although this document
applies to intentionally passivated metal surfaces, mature materials passivated by conventional
techniques (e.g. nitric acid impregnation) are generally non-hazardous and can be described in
a very basic mode.
This document does not apply to coatings for implants that use living tissues.
This document does not apply to laminated boards, i.e. multi-layer composites, for example,
artificial blood vessels composed of different expanded polytetrafluoroethylene layers, but the
exposed surface of the laminated boards can be an implant coating (see 3.1, NOTE 2).
This document does not apply to coverings, for example, stent grafts.
NOTE 1.this document does not contain biocompatibility requirements. However, this is a key
characteristic of devices and coatings and needs to be addressed during risk assessment.
NOTE 2.this document is complementary to the applicable standards on non-active surgical
implants and YY/T 0640.
NOTE 3.this document does not require the manufacturer to establish a quality management
system. However, the application of a quality management system, for example, the one
described in ISO 13485, can help ensure that the implants perform as expected.
NOTE 4.although fully porous implants are not coatings, some of the considerations in this
document can also be applied to them.

Basic Data

Standard ID	YY/T 1860.1-2024 (YY/T1860.1-2024)
Description (Translated English)	Non-active surgical implants - Implant coating - Part 1: General requirements
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C35
Classification of International Standard	11.040.40
Word Count Estimation	18,172
Date of Issue	2024-09-29
Date of Implementation	2025-10-15
Issuing agency(ies)	State Drug Administration
Summary	This standard specifies the general requirements for implant coatings for passive surgical implants, including surface coatings and surface modifications. This standard specifies requirements related to general coating performance, including chemical composition and phase composition, surface structure, coating coverage integrity, solubility, coating thickness, bond strength, wear resistance, porosity and pore size, and surface wettability. This standard applies to surface coatings, which are defined as a material layer intentionally added to a substrate with any different properties from the natural surface of the substrate. This standard applies to surface modification, which refers to the intentional transformation or reconstruction of the surface of the original substrate to form a new surface material composed of the material of the substrate itself and possible foreign materials, and forming a surface layer with different properties.