GB 12264-1990
Replaced
YY/T 0962-2021
Active
Industry standards-Medicine
YY/T 0962-2021 Cross-linked sodium hyaluronate gel for plastic surgery
YY/T 0962-2021 Cross-linked sodium hyaluronate gel for plastic surgery
Basic Information
Standard Code:
YY/T 0962-2021
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Extracorporeal circulation, artificial organs, and prosthetic devices
ICS Name:
Surgical implants, prostheses, and orthoses
Publish Date:
2021-09-06
Implement Date:
2022-09-01
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(SAC/TC 110)
Pages:
20 pages
Scope
本标准规定了整形手术用交联透明质酸钠凝胶（以下简称交联透明质酸钠凝胶)的要求、检验方法、包装和由制造商提供的信息。
本标准适用于交联透明质酸钠凝胶。
注： 交联透明质酸钠凝胶适用于皮肤及皮下组织的填充。
Development Information
Drafting Units:
中国食品药品检定研究院、北京蒙博润生物科技有限公司、华熙生物科技股份有限公司、杭州协合医疗用品有限公司、北京市医疗器械检验所、上海其胜生物制剂有限公司、爱美客技术发展股份有限公司、浙江景嘉医疗科技有限公司
Drafting Persons:
王召旭、付步芳、蒙一纯、郭学平、王金、孙伟庆、刘曦、郭盼盼、陈雄伟、于浩、华菲、顾其胜
Replace the following standards
Referenced Standards
中华人民共和国药典(四部)2020年版
GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing
GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process
YY/T 1571-2017 Tissue engineering medical device products—Sodium hyaluronate
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