medical device

Testing Medical Device

Testing Medical Device

KTC performs Type Test, Pre-market Test, General Test, and EMC.

Type Test

Test is carried out under the basis of Medical Device Law, the Provisions of Medical Device Permission, and international standards such as IEC, EN, etc.

Pre-Market Test

Pre-Market Test is applied to the secondhand imported medical devices, and shall mandatorily carry out under the current law.

EMC (Electro-Magnetic Compatibility) Test

All electric & electronic medical devices are required to be conformed to EMC standard.

General Test

General Test is done at the applicant's request and includes Quality control tests, Performance tests, etc.

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