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

Publish Date: 2025-12-02 Implement Date: 2027-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us
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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

Word Count: 38 Thousand words Pages: 28 pages

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)

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