GB 23101.1-2008 Active National standards force_standard

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

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

Publish Date: 2008-12-30 Implement Date: 2010-03-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB 23101.1-2008

Standard Type: National standards

Standard Status: Active

is_force_gb: yes

CCS Name: Orthopaedic surgery, orthopaedic instruments

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2008-12-30

Implement Date: 2010-03-01

Pages: 6 pages

Scope

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

Development Information

Word Count: 7 Thousand words Pages: 6 pages

Same series standard

GB 23101.2-2008 Implants for surgery—Hydroxyapatite—Part 2:Coatings of hydroxyapatite GB/T 23101.4-2008 Implants for surgery—Hydroxyapatite—Part 4:Determination of coating adhesion strength

Referenced Standards

ISO 13779-3 GB/T 16886.17-2005 Biological evaluation of medical devices—Part 17:Establishment of allowable limits for leachable substances GB/T 16886.17-2025 Biological evaluation of medical devices—Part 17:Toxicological risk assessment of medical device constituents

Adopt standards

ISO 13779-1:2000

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