GB 2639-1990
Replaced
YY/T 1465.6-2019
Active
Industry standards-Medicine
YY/T 1465.6-2019 Immunogenic evaluation method of medical devices—Part 6:Determination of animal spleen lymphocyte subsets by flow cytometry
YY/T 1465.6-2019 Immunogenic evaluation method of medical devices—Part 6:Determination of animal spleen lymphocyte subsets by flow cytometry
Basic Information
Standard Code:
YY/T 1465.6-2019
Standard Type:
Industry standards
Standard Status:
Active
is_force_gb:
no
CCS Name:
Medical devices
ICS Name:
Medical materials
Publish Date:
2019-07-24
Implement Date:
2020-08-01
Publisher:
国家药品监督管理局
Technical Committee:
全国医疗器械生物学评价标准化技术委员会(SAC/TC 248)
Pages:
9 pages
Scope
YY/T 1465的本部分规定了用流式细胞术测定动物脾脏淋巴细胞亚群的方法。本部分适用于评价医疗器械/材料诱导产生的免疫应答。
Development Information
Drafting Units:
山东省医疗器械产品质量检验中心、北京市医疗器械检验所
Drafting Persons:
侯丽、孙晓霞、戴政宁、贺学英、王蕊
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 16886.2-2000 Biological evaluation of medical devices—Part 2:Animal welfare requirements
GB/T 16886.2-2011 Biological evaluation of medical devices—Part 2:Animal welfare requirements
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/T 16886.20-2015 Biological evaluation of medical devices—Part 20:Principles and methods for immunotoxicology testing of medical devices
GB/T 16886.2-2026 Biological evaluation of medical devices—Part 2:Animal welfare requirements
Related Standards
GB 2641-1990
Abolished
GB 2641-1990 Tube vial for antibiotic use
GB/T 2640-1990
Replaced
GB/T 2640-1990 Injection vials for antibiotics
GB 2637-1995
Replaced
GB 2637-1995 Ampoule
GB/T 12414-1995
Replaced
GB/T 12414-1995 Pharmaceutical glass tube
GB 15980-1995
Abolished