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

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

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)

Related Standards

Contact Us