GB 12264-1990
Replaced
YY/T 1699-2020
Active
Industry standards-Medicine
YY/T 1699-2020 Tissue engineering medical device products—Chitosan
YY/T 1699-2020 Tissue engineering medical device products—Chitosan
Basic Information
Standard Code:
YY/T 1699-2020
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:
2020-02-21
Implement Date:
2021-01-01
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(SAC/TC 110/SC 3)
Pages:
18 pages
Scope
本标准规定了用于制备组织工程医疗器械产品的壳聚糖及其盐的要求、试验方法等。
本标准适用于制备组织工程医疗器械产品的壳聚糖及其盐。
Development Information
Drafting Units:
上海其胜生物制剂有限公司、中国食品药品检定研究院、青岛博益特生物材料股份有限公司
Drafting Persons:
蒋丽霞、魏长征、郭盼盼、徐丽明、邵安良、韩宝芹、宋福来
Replace the following standards
Referenced Standards
《中华人民共和国药典》(2015年版)四部
GB/T 191-2000 Packaging—Pictorial marking for handling of goods
GB/T 191-2008 Packaging—Pictorial marking for handling of goods
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
GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals
GB/T 16886.7-2015 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals
GB/T 16886.12-2000 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
GB 18278.1-2015 Sterilization of health care products—Moist heat—Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices
GB 18279.1-2015 Sterilization of health care products—Ethylene oxide—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
GB 18280.1-2015 Sterilization of health care products—Radiation—Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
YY/T 0313-1998 Package,lable,transport and storage for medical polymer products
YY/T 0313-2014 Medical polymer products—Requirement for package and information supplied by manufacturer
YY/T 0771.1-2020 Medical devices utilizing animal tissues and their derivatives—Part 1:Application of risk management
YY/T 0771.2-2020 Medical devices utilizing animal tissues and their derivatives—Part 2:Controls on sourcing,collection and handling
YY/T 0771.3-2009 Animal-derived medical devices - Part 3: Verification of removal and inactivation of viruses and transmissible spongiform encephalopathy (TSE) factors
GB/T 191-2025 Graphical symbols marking for handling and storage of packages
GB 18280.1-2025 Sterilization of health care products—Radiation—Part 1:Requirements for the development,validation and routine control of a sterilization process for medical devices
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