GB/T 4506-1984
Abolished
GB/T 14233.2-2025
Pending
National standards
GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
GB/T 14233.2-2025 Test methods for infusion,transfusion,injection equipment for medical use—Part 2:Biological test methods
Basic Information
Standard Code:
GB/T 14233.2-2025
Standard Type:
National standards
Standard Status:
Pending
is_force_gb:
no
CCS Name:
Generally, it refers to microsurgical instruments
ICS Name:
Blood transfusion, infusion, and injection equipment
Publish Date:
2025-12-02
Implement Date:
2027-01-01
Publisher:
国家市场监督管理总局、国家标准化管理委员会
Technical Committee:
全国医用输液器具标准化技术委员会(SAC/TC 106)
Pages:
28 pages
Scope
本文件描述了医用输液、输血、注射器具生物学试验方法。
本文件适用于医用输液、输血、注射器具。
Development Information
Drafting Units:
山东省医疗器械和药品包装检验研究院、广东省医疗器械质量监督检验所、山东百多安医疗器械股份有限公司、山东威高集团医用高分子制品股份有限公司、河南驼人医疗器械集团有限公司、山东中保康医疗器具有限公司
Drafting Persons:
乔春霞、侯丽、潘贤珮、张海军、房爱华、宋振宇、巩丽霞、杨立峰、范春光、董传俊
Replace the following standards
Referenced Standards
GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.3-2008 Biological evaluation of medical devices—Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity
GB/T 16886.3-2019 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity
GB/T 16886.4-2003 Biological evaluation of medical devices—Part 4:Selection of tests for interactions with blood
GB/T 16886.4-2022 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood
GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity
GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity
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 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
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 16886.23-2023 Biological evaluation of medical devices—Part 23:Tests for irritation
YY/T 0870.1-2013 Test for genotoxicity of medical devices—Part 1:Bacterial reverse mutation test
YY/T 0870.2-2013 Test for genotoxicity of medical devices—Part 2:In vitro mammalian chromosome aberration test
YY/T 0870.2-2019 Test for genotoxicity of medical devices—Part 2:In vitro mammalian chromosome aberration test
YY/T 0870.3-2013 Test for genotoxicity of medical devices—Part 3:In vitro mammalian cell gene mutation test using mouse lymphoma cells
YY/T 0870.3-2019 Test for genotoxicity of medical devices—Part 3:TK gene mutation test using mouse lymphoma cells
YY/T 0870.4-2014 Test for genotoxicity of medical devices—Part 4:Mammalian bone marrow erythocyte micronucleus test
YY/T 0870.5-2014 Test for genotoxicity of medical devices—Part 5:Mammalian bone marrow chromosome aberration test
YY/T 0870.6-2019 Test for genotoxicity of medical devices—Part 6:In vitro mammalian cell micronucleus test
YY/T 0870.7-2023 Test for genotoxicity of medical devices—Part 7:In vivo mammalian alkaline comet assay
YY/T 0870.8-2024 Test for genotoxicity of medical devices—Part 8:Unscheduled DNA synthesis test with mammalian liver cells in vivo
YY/T 0878.3-2019 Test for complement activation of medical devices—Part 3:Assay for the product of complement activation (C3a and SC5b-9)
YY/T 1649.1-2019 Test method for interactions of medical devices with platelet—Part 1:In vitro platelet count assay
YY/T 1649.2-2019 Test method for interactions of medical devices with platelet—Part 2:In vitro platelet activation products(β-TG,PF4 and TxB2)assay
YY/T 1651.1-2019 Tests for hemolysis of medical devices—Part 1:Material induced hemolysis assay
YY/T 1770.1-2021 Test method for thrombogenicity study—Part 1:Thrombogenicity study in dogs in vivo
YY/T 1911-2023 Test method of coagulation for medical devices
中华人民共和国药典(四部)
Related Standards
GB/T 11751-1989
Abolished
GB/T 11751-1989 Flexible polymeric tubes for medical use—Dimension
GB/T 12256-1990
Abolished
GB/T 12256-1990 Test method for stiffness of hypodermic needle tubing
GB/T 13074-1991
Replaced
GB/T 13074-1991 Terms of blood purification—Hemodialysis and hemofiltration
GB 14232-1993
Abolished
GB 14232-1993 Bags for human blood and blood components
GB/T 14233.2-1993
Replaced