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In-vitro cytotoxicity testing device for anesthesia breathing pipeline and working method of in-vitro cytotoxicity testing device

A technology of cytotoxicity and testing equipment, which is applied in the direction of measuring equipment, respirators, biochemical cleaning equipment, etc., can solve the problems of false positive results, test results that cannot truly reflect product toxicity, detection and evaluation, etc., and achieve accurate biological compatibility effect

Pending Publication Date: 2020-07-31
山东省医疗器械产品质量检验中心
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Problems solved by technology

Although this method can detect the cytotoxic components in the extractables in the device materials, it cannot detect and evaluate the cytotoxicity of the product under the conditions of the actual clinical use of the simulated breathing circuit, and the test results often cannot truly reflect the actual toxicity of the product. On the one hand, false positive results are prone to occur, and on the other hand, it is also easy to cause missed detection of volatile toxic substances

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  • In-vitro cytotoxicity testing device for anesthesia breathing pipeline and working method of in-vitro cytotoxicity testing device
  • In-vitro cytotoxicity testing device for anesthesia breathing pipeline and working method of in-vitro cytotoxicity testing device
  • In-vitro cytotoxicity testing device for anesthesia breathing pipeline and working method of in-vitro cytotoxicity testing device

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Embodiment Construction

[0045] The technical solutions of the present invention will be clearly and completely described below in conjunction with the accompanying drawings. Apparently, the described embodiments are some of the embodiments of the present invention, but not all of them.

[0046] The components of the embodiments of the invention generally described and shown in the figures herein may be arranged and designed in a variety of different configurations. Accordingly, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely represents selected embodiments of the invention.

[0047] Based on the embodiments of the present invention, all other embodiments obtained by persons of ordinary skill in the art without making creative efforts belong to the protection scope of the present invention.

[0048] In the description of the present invention, it should be noted that the...

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Abstract

The invention discloses an in-vitro cytotoxicity testing device for an anesthesia breathing pipeline and a working method of the in-vitro cytotoxicity testing device, and belongs to the technical field of medical instrument inspection. The testing device comprises a gas power control device, an in-vitro artificial lung breathing system and gas condensate water collecting equipment, wherein the gaspower control device comprises a cylinder for simulating breathing movement; the in-vitro artificial lung breathing system comprises a gas storage container; a gas bag is arranged in the gas storagecontainer; an airtight water seal device is arranged below the gas storage container; the in-vitro artificial lung breathing system is positioned in a heat insulation box body; and the gas condensatewater collecting equipment comprises a condensing pipe and a condensate liquid collecting bottle. According to the technical scheme of the embodiment of the invention, the cytotoxicity index of the gas pipeline is tested by simulating clinical actual use condition, the collected gas condensate liquid can be used for other biocompatibility testing requirements, and the biocompatibility testing problem of gas pipeline type medical instruments for anesthesia breathing is fundamentally solved.

Description

technical field [0001] The invention relates to the technical field of inspection and detection of medical devices, in particular to an in vitro cytotoxicity test of an anesthesia breathing circuit, in particular to an in vitro cytotoxicity testing device for an anesthesia breathing circuit and a working method thereof. Background technique [0002] The anesthesia breathing circuit is a medical gas circuit product used in conjunction with anesthesia machines, ventilators, humidifiers, and nebulizers. equipment. Anesthesia breathing tubing is a medical consumable with a large quantity and a wide range, and it is a medical device directly related to the life of a patient. Anesthesia breathing equipment belongs to Class III high-risk medical devices, and its potential biological risks need to be strictly controlled. Unlike conventional medical device products, anesthesia breathing pipelines are in contact with human respiratory tract and alveoli through gas. Therefore, convent...

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61M16/01A61M16/08C12M1/38C12M1/00C12Q1/02
CPCA61M16/01A61M16/08A61M2209/02G01N33/5014
Inventor 刘成虎盖潇潇乔春霞范春光孙令骁董秀丽
Owner 山东省医疗器械产品质量检验中心
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