GB/T 47486-2026General technical requirements for vasculature-on-a-chip (English PDF)

Foreword

GB/T 47486-2026 | General technical requirements for vasculature-on-a-chip

GB/T 47486-2026 English version. General technical requirements for vasculature-on-a-chip ICS

40 National Standards of the People's Republic of China General technical requirements for vascular chips Published on 2026-04-

30 Implemented on 2027-05-

01 State Administration for Market Regulation The State Administration for Standardization issued a statement.

1.Scope This document defines the terminology and definitions for vascular chips, specifies the technical requirements, quality control settings, labeling, accompanying documentation, and packaging. The loading, transportation, and storage of the equipment are described, along with the corresponding testing methods. This document applies to the design, production, and testing of vascular chips based on microfluidic chips.

6 Test Methods

6.1 Appearance Visual inspection.

6.2 Light transmittance According to GB/T 2410, the vascular endothelial culture chamber of the microfluidic chip should be placed in a spectrophotometer or an optical transilluminator that meets the wavelength requirements. The transmittance of the power meter is directly measured through its detection window (see Appendix A, A.2 for specific detection methods).

6.3 Sealing performance The sealing test shall be conducted according to Chapter 6 of GB/T 2423.23-2013 (see A.3 for specific test methods). The test conditions are as follows:

a) Test temperature. 1°C~5°C above the highest operating ambient temperature of the microfluidic chip;

b) Duration of conditional testing. Maintain at least

1.2 times the normal test condition operating time;

c) Method for detecting leakage. Visual inspection using a test liquid that provides a clear contrast to the background.

6.4 Operating temperature tolerance The microfluidic chip was tested for leakage under conditions deviating from its operating temperature by ±20.0°C (for a duration not less than

1.2 times the normal test duration). Check for leaks and observe the appearance for any deformation or damage (see A.4 for specific testing methods).

6.5 Biocompatibility According to GB/T 16886.5, cell morphology observation and cell activity analysis are used to detect microfluidic chip substrates and their attachments. To determine whether the material exhibits cytotoxicity (see A.5 for specific testing methods).

6.6 Shear stress on the blood vessel wall Based on the dynamic viscosity of the culture medium under constant temperature of 37°C, the preset flow rate, and the flow channel geometry of the vascular chip, the wall shear was calculated. Stress. Specifically, for a circular cross-section irrigation channel, the calculation is performed according to formula (1); for a rectangular cross-section irrigation channel, the calculation is performed according to formula (1). Calculate according to formula (2). The width of the irrigation channel should be at least 10 times its height. Subsequently, based on the target wall shear stress value, use the phase... The required culture medium volumetric flow rate (Q) is calculated by working backwards from the formula. The culture medium is then steadily and uniformly infused using a syringe pump at this calculated flow rate. The flow is injected into the vascular chip, thereby achieving the set wall shear stress within the chip. To ensure the accuracy of the flow rate, a micro-flow meter is used to monitor the injection pump. The actual output flow rate is calibrated to ensure reliable and stable injection conditions.

6.7 Biological Tissue Morphology Vascular endothelial cells are mixed with supporting cells (such as fibroblasts) in a specific ratio and then encapsulated in fibrin or collagen. The cell-gel complex was injected into the vascular culture chamber of a microfluidic chip, and the vascular complex was continuously perfused into the perfusion channel. Culture medium for endothelial growth factor. Under dynamic culture conditions (usually 5-7 days), vascular endothelial cells migrate, proliferate, and self-regulate in the matrix. Assembly ultimately forms a three-dimensional microvascular network with branches and interconnected lumens. This network can be visualized using techniques such as live-cell imaging and immunofluorescence staining. The resulting network is then subjected to morphological and functional verification (see A.6 for specific detection methods).

6.8 Biological tissue activity By constructing a circulating perfusion system consisting of a pump, a reservoir, and a vascular chip, three-dimensional vascular vessels within the vascular chip can be subjected to [the following]. A set fluid shear force was applied. Under mechanical stimulation, vascular endothelial cells secreted active substances such as NO. The circulating culture medium was then collected and analyzed. The concentration of target substances such as NO can quantify the specific release level of endothelial cells under shear stress stimulation, thereby assessing their functional response. (See A.7 for specific testing methods.)

6.9 Perfusion and fluidity of vascular tissues The perfusion tracer method was used to assess the perfusionability and fluidity of vascular tissue in a vascular chip. Fluorescent microspheres or soluble... Using dyes as tracers, time-lapse microscopy was employed to capture their motion and spatial distribution within the vascular network in real time. Through analysis... The transport pathway and filling status of the tracer are analyzed to assess the perfusion and fluidity of vascular tissues (see A.8 for specific detection methods).

7 Identification, Labeling and Accompanying Documents

7.1 Marking and Labeling The markings and labels on the product packaging boxes shall comply with the relevant provisions of GB/T 191.

8 Packaging, transportation and storage

8.1 Packaging The product packaging should meet the following requirements.

a) Under all storage and transportation conditions, the packaging ensures that the characteristics and properties of the contents remain unchanged;

b) The product is packaged in a suitable container, and any damage to the packaging seal is clearly visible.

8.2 Transportation The transportation of products shall meet the following requirements;

a) Pack the product in accordance with the manufacturer's specified transport packaging requirements;

b) Transport in accordance with the manufacturer's specified sealing conditions, temperature requirements, UV/radiation protection, etc.

c) Avoid collisions or strong vibrations during transportation.

8.3 Storage The product should be stored according to the manufacturer's requirements.