GB 23101.2-2008
Implants for surgery.Hydroxyapatite.Part 2:Coatings of hydroxyapatite (English Version)

Standard No.

GB 23101.2-2008

Language

Chinese, Available in English version

Release Date

2008

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Latest

GB 23101.2-2008

Scope

This part of GB 23101 specifies the requirements for hydroxyapatite ceramic coatings applied to metallic and non-metallic surgical implants. This standard does not apply to coatings made of glass, glass ceramics, α- and β-tricalcium phosphate or other forms of calcium phosphate, nor to coatings in which hydroxyapatite exists in powder form.

GB 23101.2-2008 Referenced Document

• GB 23101.4 Implants for surgery.Hydroxyapatite.Part 4:Determination of coating adhesion strength
• GB/T 16886.17 Biological evaluation of medical devices.Part 17:Establishment of allowable limits for leachable substances
• ISO 13779-3 Implants for surgery — Hydroxyapatite — Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity — Amendment 1*， 2021-03-08 Update

GB 23101.2-2008 history

• 2008 GB 23101.2-2008 Implants for surgery.Hydroxyapatite.Part 2:Coatings of hydroxyapatite

GB 23101.2-2008 -All Parts