Device for testing semi-in-vitro blood compatibility of cardiovascular medical instrument

A technology of blood compatibility and medical devices, which is applied in the field of testing devices for semi-in vitro blood compatibility of cardiovascular medical devices, which can solve the problems of inability to detect and evaluate blood compatibility, achieve safety assurance, and test operation is simple , good compatibility effect

Pending Publication Date: 2020-04-14
山东省医疗器械产品质量检验中心
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  • Abstract
  • Description
  • Claims
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Problems solved by technology

The above method can detect hemotoxic components in extractables in device materials, but it cannot be used for preclinical hemocompatibility testing and evaluation under conditions that simulate the actual clinical use of medical devices

Method used

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  • Device for testing semi-in-vitro blood compatibility of cardiovascular medical instrument
  • Device for testing semi-in-vitro blood compatibility of cardiovascular medical instrument
  • Device for testing semi-in-vitro blood compatibility of cardiovascular medical instrument

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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 part 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 a device for testing the semi-in-vitro blood compatibility of a cardiovascular medical instrument, and belongs to the technical field of medical instrument inspection. The device structurally comprises a main body test box and a power supply, one side of the main body test box is provided with an openable door, the other side surfaces of the main body test box are closed, and a peristaltic pump, a disinfection device and a temperature control device are arranged in the main body test box; a connecting pipeline is further arranged in the main body test box and penetratesthrough the peristaltic pump, and arteriovenous puncture needles are arranged at the two ends of the connecting pipeline respectively; and the power supply is connected with the peristaltic pump, thedisinfection device and the temperature control device. The invention further discloses a using method of the testing device. According to the technical scheme, the blood compatibility indexes such as hemolysis, blood coagulation and thrombosis of the medical instrument are truly tested by simulating the actual clinical use condition, the test requirements of products of different types and models can be met by adjusting different flow rates, and the blood compatibility test requirements of the cardiovascular medical instrument are met.

Description

technical field [0001] The invention relates to the technical field of medical device testing, in particular to a device for testing the blood compatibility of the semi-in vitro blood compatibility of cardiovascular medical devices. Background technique [0002] Cardiovascular medical devices are high-risk medical devices under national key supervision. After such devices come into contact with blood, they may trigger a series of complex biological reactions involving cellular components, factors and proteins in the blood, and may produce such Serious health risks caused by hemolysis, coagulation, thrombosis and other side effects must be identified and controlled in pre-market quality testing. [0003] At present, the usual method for blood compatibility quality testing before the market of cardiovascular medical devices in the world is to use ISO10993-4:2017 "Biological Evaluation of Medical Devices Part 4: Selection of Interaction Tests with Blood" and GB / T14233.2 -The m...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/00
CPCG01N33/00G01N2033/0078
Inventor 刘成虎乔春霞林振华孙光宇赵增琳孙晓霞施燕平
Owner 山东省医疗器械产品质量检验中心
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