| Customization: | Available |
|---|---|
| After-sales Service: | 1 Year |
| Warranty: | 1 Year |
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Applicable Standard
YY/T 0616.5-2019 Medical Gloves - Part 5: Method for Continuous Contact Test to Resist Chemical Penetration ASTM D6978
ISO 14644 Portable Integrity Tester For Rubber Gloves Glove Integrity Analyzer Glove Integrity Tester
Technical Indicators
| Material & anti-corrosion performance of test device | The test device is made of stainless steel, with rust and corrosion resistance functions |
| Composition of the device | Composed of test tank, circulating water pump, penetration test tank, sealed box and corresponding pipelines |
| Pressure control accuracy | +2% of the upper limit of the test pressure value, -1% of the lower limit |
| Pressure measurement range & accuracy | Measurement range: 0 - 500KPa; Accuracy: ±0.5% |
| Peristaltic pump flow range | 0 - 10L/MIN |
| Outer shell | Made of stainless steel and treated with baking paint |
| Control system | PLC, with fully automatic liquid filling, fully automatic sampling and fully automatic liquid replenishment |
| Operation interface | Chinese-English switching |
| Water bath | 1 piece |
| Built-in air storage tank | 2L |
| Penetration test tank & accessories | The penetration test tank is made of stainless steel, including challenge chamber, collection chamber and other accessories |
Closed Test Setup
1. During the closed test, the system's minimum sensitivity should be able to detect a permeation rate of 0.1 μg/(cm2·min) within a 5-minute sampling period.
Note: The closed test requires an increased sensitivity of the analysis. A smaller chamber can be used to reduce the volume of the collection medium. The sensitivity of the method can be improved by increasing the ratio of the sample area to the volume of the collection medium. However, these methods for increasing sensitivity must be based on sufficient volume and mixing ratio to avoid interfering with the permeation process.
2. The test chemicals are used to evaluate the performance of medical gloves materials. They can be a single component (such as pure liquid) or multiple components (such as a mixture).
Note: The test chemicals can be volatile (i.e., the vapor pressure at 25 ºC is greater than 1 mm Hg); or soluble in water, or soluble in other liquids that do not react with the glove material.
3. The collection medium should not interact with the glove material and must have sufficient permeation volume. Usually, the test chemicals for the closed device are inorganic acid-base solutions, and the collection medium is laboratory water in accordance with GB/T6682.
Note: There should be sufficient permeation volume. The permeation within any test time should not exceed 20% of its saturated concentration. For liquid collection medium, the saturation is the maximum solubility or miscibility of the permeate at the test temperature.
4. The barrier performance of medical glove materials against chemical permeation can be evaluated by measuring the breakthrough detection time, standard breakthrough detection time, permeation rate, and cumulative permeation over a period of time. These values are key indicators for judging the effectiveness of medical glove materials in blocking chemicals. The longer the breakthrough detection time and standard breakthrough detection time, and the smaller the cumulative permeation and permeation rate, the better the isolation characteristics of the gloves. Note: Currently, most chemicals have only limited quantitative information on the acceptable level of skin contact, so the data obtained from this test method cannot be used to infer the safe contact level.
Test Chamber
This test instrument consists of two chambers for contacting the samples. Figure 1 shows an example of test chamber 1). It is usually made of glass with a diameter of approximately 25mm. The length of the challenge chamber is preferably about 25mm, and the length of the collection chamber is preferably equal to or less than 32mm for holding the test chemicals and collecting media.
Note 1: The test chamber can also be fabricated by oneself.
Note 2: When the test chemicals are incompatible with glass (such as hydrofluoric acid), a test chamber made of non-glass materials (such as stainless steel) is required. Medical gloves can be considered for the chemical substances used in the permeation test.
1. The ports of the challenge chamber and the collection chamber should be designed to be outwardly turned into a flange shape to facilitate the clamping of the two chambers during the test.
2. The inlet and outlet pipes of the collection chamber can be equipped with a stop valve. The positions of the pipe openings should be appropriate, and the inner diameters of the pipes, ports, stop valves, etc. should be at least 2mm to prevent additional pressure differences in the system.
3. Both chambers of the test chamber are equipped with a standard conical port for adding and releasing the test chemicals and collecting media. If necessary, the collection chamber opening can also be used to insert a stirrer into the chamber.
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