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Method for removing the in-vitro cytotoxicity for disposable sterilized syringe

A cytotoxic and syringe technology, applied in the field of medical devices, can solve problems such as the inability to meet technical requirements, and achieve the effects of improving the dissolution rate and eliminating cell damage.

Active Publication Date: 2010-12-29
丹阳市金晟医用橡塑制品有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Its cytotoxicity test (in vitro method) is below the third level, which cannot meet the technical requirements of the GB / T16886.5 standard

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0014] 1. Pressurized high-temperature cooking: 500 kg of products, 1,000 kg of pure water, pressure of 0.25 MPa, temperature of 125°C, and time of 4.0 hours.

[0015] 2. Pickling treatment: After the pressurized high-temperature cooking is completed, the pressure is released, and 2.0 kg of food-grade hydrochloric acid with a concentration of 25% is injected into the tank, the tank cover is closed, and the tank is taken out after 0.5 hours of stewing.

[0016] 3. Rinse and dry: Rinse the products out of the can with water for injection in a 100,000-class clean workshop, and pack after drying.

Embodiment 2

[0018] 1. Pressurized high-temperature cooking: 300 kg of products, 600 kg of pure water, pressure of 0.20 MPa, temperature of 120 °C, and time of 3.0 hours.

[0019] 2. Pickling treatment: After the pressurized high-temperature cooking is completed, the pressure is released, and 1.2 kg of food-grade hydrochloric acid with a concentration of 25% is injected into the tank, the lid is closed, and the tank is taken out after 0.5 hours of stewing.

[0020] 3. Rinse and dry: Rinse the products out of the can with water for injection in a 100,000-class clean workshop, and pack them after drying.

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PUM

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Abstract

The invention relates to a method for removing the in-vitro cytotoxicity for disposable sterilized syringe, and is characterized in that the method comprises the following steps: 1) pressurizing and steaming at high temperature; 2) washing with acid; 3) rinsing and drying. In the invention, steaming is carried out under the condition of increasing pressure and temperature, thereby improving the solubility and dissolving speed rate of harmful chemical substance in cleaning solution; in acid soaking process, the harmful substance on the surface of the product is further removed, thereby greatly reducing or removing the damage of the harmful chemical substance to the cell, enabling the in-vitro cytotoxicity test to reach 0-1 grade and meeting GB / T16885.5 standard.

Description

technical field [0001] The invention relates to a medical device, in particular to a method for removing cytotoxicity in vitro of a plunger used in a disposable sterile syringe. Background technique [0002] The biological safety evaluation of medical devices was introduced from the international standard ISO10993 series of standards, which were transformed into GB / T16886 series of standards after equivalent domestic adoption. Due to the slow transformation of national industry standards, the currently implemented standard "YY / T0243-2003 Piston for Disposable Sterile Syringes" has not yet implemented requirements for the GB / T16886 standard. However, some foreign businessmen proposed that since 2010, the product must also provide an in vitro cytotoxicity test report according to the GB / T16886.5 standard. Pistons for disposable sterile syringes are medical rubber products, which belong to the third category of medical devices. The traditional production process of this produc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M5/178
Inventor 桂双才
Owner 丹阳市金晟医用橡塑制品有限公司
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