Skin sensitization test

Assess and evaluating allergic reactions, including activated immune system, to medical equipments

Acute / subacute / sub-chronic / chronic toxicity test

Assessment of systemic toxicity in single-dose administration of medical equipments

Pyrogenic test

Assess the presence of pyrogenic substances in medical equipments

Intradermal test

Assess the potential stimulus of the material that may appear after intradermal injection using medical equipments

Transplantation test

Assess the sectional effects of biotissues on medical devices

Skin irritation test

Assess the potential stimulus of the material that may appear after intradermal injection using medical equipments

Transplantation test

Assess the potential stimulus of the material that may appear after the medical equipments were applied on the eye membrane

Biocompatibility test of lens

Evaluation of biocompatibility after applying the medical equipments on lens

Endotoxin test

Method ot detecting or quantifying endotoxin derived from gram-Negative bacillus using lysate reagent

Hemolytic test

Evaluation of the blood compatibility by testing the degree of hemolysis of a medical equipment that can contact blood in vitro. Or, evaluation of the degree of hemolysis when the medical equipment is brought into direct contact with the blood of a rabbit in vitro.

Cytotoxicity test

Evaluation of the effects on the human body based on the degree of cell dissolution(death) and inhibition rate of cell growth by the eluate using cell culture technology

Reverse mutation test for microorganisms

In case the ability of a certain microorganism to synthesize a specific amino acid has been declined, we can check whether it is transformed into amino acid-synthesizing strain with this test

Chromosome abnormality test

This is a test to check the cytotoxic effect of the tested substance at the cellular level, generally using mammalian cells.

Micronucleus test

To check the genotoxicity, in-vivo animal test needs to be conducted. If the number of polychromatic red cells increase, it means that the tested substance has damaged the chromosome or caused an abnormality before the cell was divided.

Sterility test

For the sterilized medical equipments, we evaluate the suitability of sterilization by checking the existence of microorganisms proliferated by cultivation method

Testing the residue of EO gas

Evaluate the suitability of the sterilizationby checking the amount of ethylene oxide, ethylene glycol and ethylene chlorohydrin that remains on the medical equipment sterilized by ethylene oxide.

Evaluation of microorganisms in the product

ISO 11737-1 Determination of a population of microorganisms on products According to ‘ISO 11737-1 Determination of a population of microorganisms on products’, the degree of microbial contamination on medical equipments before sterilization can be assessed

Test at sterilized condition

ISO 11737-2 Tests of sterility performed in the validation of a sterilization process According to ‘ISO 11737-2 Tests of sterility performed in the validation of a sterilization process ’, this test is used to verify the efficacy of sterilization process

Eluate test

The chemical properties of the materials used in the raw materials and manufacturing process of medical equipments can be evaluated by the method of Korean Pharmacopoeia and the USP method.

Test to identify the components

Qualitative / quantitative evaluation of raw materials of medical equipments by using analytical equipments such as ICP, GC, HPLC, etc.

Environmental monitoring test

Measurement of surface contaminants, airborne microorganisms, and floating microorganism in a Clean Room where the medical equipments are manufactured

This is the test in reference to the common standard regarding IEC60601-1 or electrical·mechanical safety. Detailed test items are as follows.

Energy limit, enclosure and protective cover, protective earth, leakage current, withstand voltage, mechanical strength, stability test, normal temperature rise, injection test, container pressure test, abnormal operation, cord fixation test, transformer test, insulation distance measurement

This is the test in reference to IEC 60601-1-2 or the ‘Common Criteria for Electromagnetic Safety’(notified by the Ministry of Food and Drug Safety). Details are as follows.

Electromagnetic Interference (EMI)

Electromagnetic wave conduction and electromagnetic wave radiation test

Electromagnetic Susceptibility (EMS)

Electrostatic discharge, radioactive RF electromagnetic field, electrical rapid transient phenomenon, surge test, conducting RF electromagnetic field, power frequency magnetic field, voltage drop sudden blackout and voltage fluctuation test on power supply input Line, and power frequency fluctuation test

Output frequency and accuracy test

Measures output frequency and accuracy of ultrasonic scanning apparatus, light beam irradiator, laser surgical instrument, low frequency stimulator, etc.

Test of the wavelength of light source

Measures the wavelength band of laser, infrared, ultraviolet and visible ray

Test of safety devices

Test for safety devices(alarm, overcurrent cutoff, fuse blow, interlock, safety valve, etc.) of products

Load test

Evaluates mechanical properties (tensile strength, tensile load, etc.) of medical equipments by applying tensile force to them

Bending test

Measures deformation resistance or breaking strength when a bending moment is applied to the material

Fatigue test

When a medical equipment is applied to human body, it is necessary to prevent an unexpected destruction in advance and predict its life cycle and replacement period. Eventually, this test is necessary to ensure safety and to prevent material and human damage

Expiration test of medical equipment

In order to set the period during which the performance or efficacy of the medical equipment can be maintained normally, we use ‘accelerated aging’ technology. Using this test, we can verify the validity of a medical equipment within a short period of time. Also, we can check the physical safety of the package and biological safety of the product.