GB 8662-1988
Replaced
YY/T 1910-2023
Active
Industry standards-Medicine
YY/T 1910-2023 Medical-grade beta-tricalcium phosphate powder for additive manufacturing
YY/T 1910-2023 Medical-grade beta-tricalcium phosphate powder for additive manufacturing
Basic Information
Standard Code:
YY/T 1910-2023
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Surgical instruments and materials
Publish Date:
2023-09-05
Implement Date:
2024-09-15
Publisher:
国家药品监督管理局
Technical Committee:
中国食品药品检定研究院
Pages:
12 pages
Scope
本文件规定了用于增材制造的医用β-磷酸三钙粉末的性能要求、试验方法、标识、包装、运输和贮存。
本文件适用于光固化、挤出式和铺粉增材制造工艺的医用β-磷酸三钙粉末。
Development Information
Drafting Units:
点云生物(杭州)有限公司、中国食品药品检定研究院、迈海新型材料科技(固安)有限公司、西北工业大学、浙江理工大学、华南理工大学医疗器械研究检验中心、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、国家人体组织功能重建工程技术研究中心、浙江省医疗器械检验研究院、上海贝奥路生物材料有限公司、浙江埃普瑞纳米新材料股份有限公司、苏州鼎安科技有限公司
Drafting Persons:
曾庆丰、魏静、韩倩倩、毛歆、刘振齐、于树印、刘永胜、孔祥东、刘佳、邓翔、马春宝、任力、徐萍华、卢霄、倪成辉、李亚东
Referenced Standards
YY/T 0683-2008 Standard specification for beta-tricalcium phosphate for surgical implantation
ISO 23145-1
ISO 23145-2
中华人民共和国药典(2020年版 四部)
GB/T 19077-2016 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 19587-2004 Determination of the specific surface area of solids by gas adsorption using the BET method
GB/T 19587-2017 Determination of the specific surface area of solids by gas adsorption using the BET method
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
GB/T 35021-2018 Additive manufacturing—Process categories and feedstock
GB/T 35351-2017 Additive manufacturing—Terminology
GB/T 39696-2020 Determination of flowability of fine ceramic powders—Calibrated funnel
GB/T 19077-2024 Particle size analysis—Laser diffraction methods
GB/T 35351-2025 Additive manufacturing—Terminology
Related Standards
GB 2766-1995
Replaced
GB 2766-1995 Haemostatic forceps with box joint—General specifications
GB/T 10160-1995
Abolished
GB/T 10160-1995 Test methods of locking force and opening force for medical use forceps
GB 9706.4-1999
Replaced
GB 9706.4-1999 Medical electrical equipment—Part 2:Particular requirements for the safety of high frequency surgical equipment
YY 0464-2003
Replaced
YY 0464-2003 Single use hemoperfutor
YY 0054-2003
Replaced