GB 8662-1988
Replaced
YY/T 1995-2025
Pending
Industry standards-Medicine
YY/T 1995-2025 Tissue engineered medical device products—Evaluation experiment of cellular biological effects of cartilage scaffold
YY/T 1995-2025 Tissue engineered medical device products—Evaluation experiment of cellular biological effects of cartilage scaffold
Basic Information
Standard Code:
YY/T 1995-2025
Standard Type:
Industry standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Surgical instruments and materials
Publish Date:
2025-10-30
Implement Date:
2026-11-01
Publisher:
国家药品监督管理局
Technical Committee:
全国外科植入物和矫形器械标准化技术委员会组织工程医疗器械产品分技术委员会
Pages:
16 pages
Scope
本文件规定了体外检测细胞在软骨支架上增殖、迁移、分化的试验方法。
本文件适用于对软骨支架细胞生物学效应的评价。
Development Information
Drafting Units:
中国食品药品检定研究院、国家药品监督管理局医疗器械技术审评中心、浙江大学、中国人民解放军总医院、四川大学、康膝生物医疗(深圳)有限公司、浙江星月生物科技股份有限公司、华夏司印(上海)生物技术有限公司
Drafting Persons:
陈亮、郭晓磊、欧阳宏伟、郭全义、林海、李鉴墨、赵洪石、陈丽媛、陈慧敏
Referenced Standards
YY/T 1562-2017 Tissue engineering medical device products—Biomaterial scaffolds—Guide for cell viability evaluation
YY/T 1744-2020 Tissue engineering medical device products—Bioactive ceramics—Method to measure cell migration in porous materials
YY/T 1810-2022 Tissue-engineered medical products—Quantification of sulfated glycosaminoglycans (sGAG) for evaluation of chondrogenesis
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