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YY/T 0606.15-2023 Active Industry standards-Medicine

YY/T 0606.15-2023 Tissue engineered medical products—Standard practice for evaluation of immune responses of substrate and scaffolds products:Lymphocyte proliferation tests

YY/T 0606.15-2023 Tissue engineered medical products—Standard practice for evaluation of immune responses of substrate and scaffolds products:Lymphocyte proliferation tests

Publish Date: 2023-01-13 Implement Date: 2024-01-15 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0606.15-2023
Standard Type: Industry standards
Standard Status: Active
is_force_gb: no
CCS Name: Medical optical instruments and equipment, and endoscopes
ICS Name: Surgical instruments and materials
Publish Date: 2023-01-13
Implement Date: 2024-01-15
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: 11 pages

Scope

本文件规定了评价组织工程医疗产品基质或支架所致哺乳动物细胞免疫反应的试验方法：淋巴细胞增殖试验。
本文件适用于组织工程医疗产品基质或支架的生物学评价。
注： 除本文件所选方法外，可采纳其他等效方法。

Development Information

Drafting Units:

中国食品药品检定研究院、北京市医疗器械检验研究院

Drafting Persons:

陈亮、陈丽媛、戴政宁、贺学英、杜晓丹、邵安良、魏利娜

Word Count: 24 Thousand words Pages: 11 pages

Replace the following standards

YY/T 0606.15-2014 Tissue engineered medical products—Part 15:Standard practice for evaluation of immune responses of substrate and scaffolds products:Lymphocyte proliferation tests

Referenced Standards

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 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.6-2015 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.10-2000 Biological evaluation of medical devices—Part 10:Tests for irritation and sensitization GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization GB/T 16886.10-2024 Biological evaluation of medical devices—Part 10:Tests for skin sensitization 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

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