GB 23101.1-2008
Implants for surgery.Hydroxyapatite.Part 1:Ceramic hydroxyapatite (English Version)

Standard No.

GB 23101.1-2008

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 23101.1-2008

Scope

This part of GB 23101 specifies the requirements for hydroxyapatite ceramics used as surgical implants. This standard does not apply to hydroxyapatite coatings, non-ceramic hydroxyapatite, hydroxyapatite powders, glass ceramics, α- and β-tricalcium phosphate or other forms of calcium phosphate.

GB 23101.1-2008 Referenced Document

• 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 23101.1-2008 history

• 2008 GB 23101.1-2008 Implants for surgery.Hydroxyapatite.Part 1:Ceramic hydroxyapatite

GB 23101.1-2008 -All Parts