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
Price:
$ 84
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
Pages:
28 pages
Scope
This document describes the biological testing methods for medical infusion, blood transfusion, and injection devices.
This document is applicable to medical infusion, blood transfusion, and injection devices.
Development Information
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
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GB/T 11751-1989 Flexible polymeric tubes for medical use—Dimension
GB/T 12256-1990
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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