Standard No.:	GB/T 14233.2-2025
English Name:	Test methods for infusion, transfusion, injection equipment for medical use—Part 2: Biological test methods
Chinese Name:	医用输液、输血、注射器具检验方法 第2部分：生物学试验方法
Professional Classification:	GB    National Standard
Source Content Issued by:	SAMR;SAC
Issued on:	2025-12-2
Implemented on:	2027-1-1
Status:	to be valid
Superseding:	GB/T 14233.2-2005 Test methods for infusion, transfusion, injection equipment for medical use-Part 2: Biological test methods
Target Language:	English
File Format:	PDF
Word Count:	12000 words
Translation Price(USD):	360.0
Delivery:	via email in 1 business day

GB/T 14233.2-2025 Test methods for infusion, transfusion, injection equipment for medical use - Part 2: Biological test methods 1 Scope This document describes the biological test methods for infusion, transfusion, injection equipment for medical use. This document is applicable to infusion, transfusion, injection equipment for medical use. 2 Normative references The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition (including any amendments) applies. GB/T 16886.3 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.4 Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood GB/T 16886.5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity GB/T 16886.6 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation GB/T 16886.10 Biological evaluation of medical devices - Part 10: Tests for skin sensitization GB/T 16886.11 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity GB/T 16886.12 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials GB/T 16886.23 Biological evaluation of medical devices - Part 23: Tests for irritation YY/T 0870 (all parts) Test for genotoxicity of medical devices YY/T 0878.3 Test for complement activation of medical devices - Part 3: Assay for the product of complement activation (C3a and SC5b-9) YY/T 1649.1 Test method for interactions of medical devices with platelet - Part 1: In vitro platelet count assay YY/T 1649.2 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 Tests for hemolysis of medical devices - Part 1: Material induced hemolysis assay YY/T 1770.1 Test method for thrombogenicity study - Part 1: Thrombogenicity study in dogs in vivo YY/T 1911 Test method of coagulation for medical devices Pharmacopoeia of the People's Republic of China (Volume IV) 3 Terms and definitions No terms and definitions are specified in this document. 4 Preparation of extract 4.1 General requirements The extract shall be prepared in accordance with GB/T 16886.12, and the extraction conditions shall simulate, as far as possible, the clinical conditions of use of the sample (e.g. the contact area, time and temperature of the sample). The simulated extraction time shall not be less than the normal use duration of the sample; otherwise, the feasibility and rationale shall be justified. Where the sample is intended for prolonged use (e.g. more than 24 h), it shall be considered to prepare the extract under more stringent test conditions, but the feasibility and rationale should be justified. The test shall be performed on the finished product, representative samples taken from the finished product, materials manufactured by the same process as the finished product, or the extract prepared from the above samples or materials. 4.2 Main equipment Laminar flow clean bench or biosafety cabinet, electronic balance, constant temperature oscillation incubator, thermostatic water bath, pressure steam sterilizer, electrically heated drying oven, etc. 4.3 Containers for extraction Unless otherwise specified, extraction shall be carried out in clean, chemically inert and closed containers. The following containers shall be used to ensure that they do not interfere with the extract of the test material: a) Borosilicate glass test tubes with covers lined with an inert material (e.g. polytetrafluoroethylene); or b) Other inert extraction containers required for specific materials and/or extraction procedures. 4.4 Extraction vehicle Both polar and non-polar extraction vehicles shall be used for extraction. In specific cases for certain devices, it may be appropriate to extract in only one extraction vehicle (either polar or non-polar).. Where extraction is carried out using only one vehicle, the reason shall be provided. Common extraction vehicles are as follows: a) 0.9% sodium chloride injection; b) Refined vegetable oil; Note 1: For refined vegetable oil used in the tests specified in this document, cottonseed oil or sesame oil complying with the requirements of the Pharmacopoeia, or other vegetable oils verified to be free from biological toxic response, is recommended. c) Serum-free or serum-containing cell culture medium.

Contents Foreword i Introduction iii 1 Scope 2 Normative references 3 Terms and definitions 4 Preparation of extract 5 Pyrogen test 6 Acute systemic toxicity test 7 Tests for interactions with blood 8 Cytotoxicity test 9 Sensitization test (maximum dose method) 10 Intradermal reaction test 11 Test for local effects after implantation 12 Repeated exposure systemic toxicity test 13 Genotoxicity test Bibliography