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

Publish Date: 2020-02-21 Implement Date: 2021-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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

Word Count: 34 Thousand words Pages: 18 pages

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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

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