ICS 11.040.20
CCS C 31
National Standard of the People's Republic of China
GB/T 14233.2-2025
Replaces GB/T 14233.2-2005
Test methods for infusion, transfusion, injection equipment for medical use—Part 2: Biological test methods
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
(This is a draft translation for reference among interesting stakeholders. The finalized translation (passing through draft translation, self-check, revision and verification) will be delivered upon being ordered.)
Issue date: 2025-12-02 Implementation date: 2027-01-01
Issued by the State Administration for Market Regulation
the Standardization Administration of the People's Republic of China
Contents
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Preparation of extraction liquids
5 Pyrogen test
6 Acute systemic toxicity test
7 Test for interaction with blood
8 Cytotoxicity test
9 Sensitization test (maximization method)
10 Intracutaneous reactivity test
11 Test for local reactions after implantation
12 Repeated exposure systemic toxicity test
13 Genotoxicity test
References
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 medical infusion, transfusion, and injection equipment.
This document applies to medical infusion, transfusion, and injection equipment.
2 Normative references
The provisions in the following documents constitute essential clauses of this document through normative references. For dated references, only the edition corresponding to the date applies to this document. For undated references, the latest edition (including all amendments) applies to this document.
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 0870.1 (All parts) Test for genotoxicity of medical devices
YY/T 0878.3 Test for complement activation of medical devices
YY/T 1649.2 Test method for interactions of medical devices with platelet
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 (Chinese Pharmacopoeia,ChP)
3 Terms and Definitions
This document does not contain any terms or definitions that require specification.
4 Preparation of Extraction Liquids
4.1 General Requirements
The preparation of extraction liquids shall comply with the provisions of GB/T 16886.12 and simulate the clinical use conditions of the sample as closely as possible (e.g., contact area, time, temperature, etc.). The simulated extraction time shall not be less than the normal use time of the sample; otherwise, its feasibility and reasonableness shall be justified. When the sample’s use time is long (e.g., exceeding 24 hours), intensified extraction conditions shall be considered for preparing the extraction liquid, but their feasibility and reasonableness should be justified.
Testing shall be performed on the final product, representative samples taken from the final product, materials manufactured using the same process as the final product, or extraction liquids prepared from such samples or materials.
4.2 Main Equipment
Ultra-clean workbench or biological safety cabinet, electronic balance, constant temperature oscillation incubator, constant temperature water bath, pressure steam sterilizer, electric drying oven, etc.
4.3 Extraction Containers
Unless otherwise specified, extraction shall be carried out in clean, chemically inert, and sealed containers.
To ensure that the extraction container does not interfere with the extraction liquid of the test material, the extraction container shall be:
a) Borosilicate glass test tubes with seals lined with inert materials (e.g., polytetrafluoroethylene); or
b) Other inert extraction containers required for specific materials and/or extraction procedures.
4.4 Extraction Media
Both polar and non-polar extraction media shall be used during extraction. In specific cases for certain devices, extraction in only one medium (polar or non-polar) may be appropriate. If extraction is performed in only one medium, justification shall be provided. Common extraction media include:
a) 0.9% sodium chloride injection;
b) Refined vegetable oil;
Note 1: The refined vegetable oil used in the tests of this document is recommended to be cottonseed oil or sesame oil conforming to pharmacopoeia regulations, or other vegetable oils validated to be free of biological toxicity.
c) Cell culture medium without serum or with serum.
Note 2: Other suitable validated extraction media may be selected if necessary.
4.5 Selection and Preparation of Samples
The preparation method for extraction liquids shall refer to Table 1. If not applicable, other suitable validated extraction liquid preparation methods may be used.
Table 1 Extraction Liquid Preparation Methods
…. ….
…. ….
5 Test for Pyrogen
5.1 Purpose
This test involves injecting the sample extraction liquid into the veins of rabbits and observing whether there is an increase in the rabbits' body temperature within a specified period, to determine whether the sample has potential material-induced pyrogenic effects.
5.2 Reagents
0.9% Sodium Chloride Injection.
5.3 Main Equipment and Apparatus
Electric drying oven, electric constant temperature water bath, pressure steam sterilizer, pyrogen thermometer or rectal thermometer, constant temperature oscillation incubator, electronic balance, syringes, etc.
5.4 Preparation Before Testing
5.4.1 Depyrogenation of Apparatus
All glassware in contact with the sample/extraction liquid shall be placed in an electric drying oven and dry-heated at 250°C for at least 30 minutes. Other suitable methods for depyrogenation may also be used.
5.4.2 Temperature Measuring Instruments
The measurement of rabbit body temperature shall be performed using a pyrogen thermometer or rectal thermometer with an accuracy of ±0.1°C.
5.4.3 Laboratory Environment
One to two days prior to the test, the rabbits intended for the test shall be kept in an environment with the same temperature. The temperature difference between the laboratory and the housing room should not exceed 3°C. The laboratory temperature should be maintained between 17°C and 25°C.
Throughout the entire test process, the room temperature variation should not exceed 3°C. Measures should be taken to prevent animal agitation and avoid noise disturbances.
5.4.4 Test Rabbits
Use test rabbits that comply with the requirements specified in Volume IV, Test for Pyrogen, of the Pharmacopoeia of the People's Republic of China.
5.5 Test Method
5.5.1 Preparation of Extraction Liquid
Select suitable extraction conditions in accordance with the provisions of Clause 4.
5.5.2 Test Procedure
Perform the test according to the method specified in Volume IV, Test for Pyrogen, of the Pharmacopoeia of the People's Republic of China. The injection dose for rabbits is 10 mL/kg.
5.5.3 Result Evaluation
Evaluate the results according to the criteria specified in Volume IV, Test for Pyrogen, of the Pharmacopoeia of the People's Republic of China.
5.6 Test Report
The test report should provide the following information:
a) Sample name;
b) Production batch number;
c) Method used for preparing the extraction liquid;
d) Injection dose;
e) Record of rabbit body temperatures;
f) Result evaluation.
6 Acute Systemic Toxicity Test
6.1 Purpose
This test involves injecting the sample extraction liquid into mice intravenously and intraperitoneally and observing the mice for toxic reactions and mortality within a specified period, to determine whether the sample has potential acute systemic toxicity.
