Hatano Research Institute (HRI) Agent

HAtano Research Institute (HRI) is a supplier of biocompatibility testing control materials, providing high-density polyethylene negative rods and ZDEC polyurethane films that can be used for in vitro cytotoxicity experiments, implantation experiments, and hemolysis experiments. These products can meet the requirements of ISO 10993/GB 16886, the United States Pharmacopeia, and the Chinese Pharmacopoeia series standards.

Hatano Research Institute (HRI) can provide the following details of reference materials:

1. High density polyethylene reference material

High density polyethylene film

Negative RM-C

2. High density polyethylene negative rod

high density polyethylene rod

Negative RM-E

3. High density polyethylene negative rod

high density polyethylene rod

Negative RM-H

4. ZDEC polyurethane film

ZDEC Polyurethane film

Positive RM-A

5. ZDBC polyurethane film

ZDBC Polyurethane film

Positive RM-B

6. High density polyethylene reference material

High density polyethylene film

Negative RM-D

lifeThe reference material for material compatibility testing refers to one or more characteristic values with sufficient reproducibility, which have been appropriately characterized and can be used to calibrate instruments, evaluate measurement methods, or assign values to materials. Biocompatibility test control material refers to the material used as a control in biological experiments, which can exhibit reproducibility reactions (such as positive or negative reactions) to confirm the suitability of the test steps.

The significance of biological evaluation lies in predicting the potential hazards of medical devices during contact with the human body, and it plays a very important role in medical device evaluation. The main advantages of using control materials in biological experiments are as follows:

(1) The application of biocompatibility testing control materials is beneficial for standardizing evaluation methods and ensuring the effectiveness, accuracy, and reproducibility of results.

(2) The application of biocompatibility testing control materials is beneficial for comparing test results between different laboratories.

(3) Using reference materials is also beneficial for discovering some technical errors.