GB 12264-1990
Replaced
GB/T 41672-2022
Active
National standards
GB/T 41672-2022 Implants for surgery—Osteoinductive calcium phosphate bioceramics
GB/T 41672-2022 Implants for surgery—Osteoinductive calcium phosphate bioceramics
Basic Information
Standard Code:
GB/T 41672-2022
Standard Type:
National standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Orthopaedic surgery, orthopaedic instruments
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2022-07-11
Implement Date:
2023-08-01
Publisher:
国家市场监督管理总局、国家标准化管理委员会
Technical Committee:
全国外科植入物和矫形器械标准化技术委员会(SAC/TC 110)
Pages:
13 pages
Scope
本文件规定了骨诱导磷酸钙生物陶瓷的技术要求和试验方法。
本文件适用于外科植入用骨诱导磷酸钙生物陶瓷。
Development Information
Drafting Units:
四川大学、四川医疗器械生物材料和制品检验中心有限公司、天津市医疗器械质量监督检验中心、四川拜阿蒙生物活性材料有限责任公司
Drafting Persons:
朱向东、李向锋、袁暾、梁洁、邓翔、张凯、张兴栋、陈和仲、张丽、邹文、李雪峰、马春宝、李立宾
Referenced Standards
GB/T 16886.20-2015 Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices
GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials
GB/T 16886.23-2023 Biological evaluation of medical devices—Part 23:Tests for irritation
GB/T 19077-2016 Particle size analysis—Laser diffraction methods
GB/T 19077-2024 Particle size analysis—Laser diffraction methods
GB/T 19077.1-2003 Particle size analysis—Laser diffraction method
GB/T 19077.1-2008 Particle size analysis—Laser diffraction methods—Part 1:General principles
GB/T 21650.1-2008 Pore size distribution and porosity of solid materials by mercury porosimetry and gas adsorption—Part 1:Mercury porosimetry
GB/T 21650.1-2026 Evaluation of pore size distribution and porosity of solid materials by mercury porosimetry and gas adsorption—Part 1:Mercury porosimetry
GB/T 23101.3-2010 Implants for surgery—Hydroxyapatite—Part 3:Chemical analysis and characterization of crystallinity and phase purity
GB/T 23101.3-2023 Implants for surgery—Hydroxyapatite—Part 3:Chemical analysis and characterization of crystallinity ratio and phase purity
YY/T 1447-2016 Implants for surgery—In vitro evaluation for apatite-forming ability of implant materials
中华人民共和国药典(四部2020年版)
ISO 13383-1:2016
Related Standards
GB 12279-1990
Replaced
GB 12279-1990 Cardiac valve prostheses general technical specification
GB 12417-1990
Replaced
GB 12417-1990 The general technological conditions of surgical metal implant
GB/T 13461-1992
Replaced
GB/T 13461-1992 Synthetic resin blow knee prostheses
GB/T 14191-1993
Replaced
GB/T 14191-1993 Terminology for prosthetics and orthotics
GB 14722-1993
Replaced