The ConformiTICs Lab provides independent testing and inspection services for product safety to a wide range of industries, manufacturers and other market players.
Its main testing and inspection areas are medical, laboratory, consumer electronics, IT and automotive products. The changes require manufacturers to certify the conformity of devices to the latest standards and requirements.
This will be done by the designated certification bodies, which will hold manufacturers to account, and in most cases compliance can be demonstrated by a third party independent test and report.
WHAT CAN WE OFFER?
Testing and evaluation of medical devices
The CE mark is a prerequisite for the placing on the market of medical devices, which requires various tests to be carried out. An important requirement for medical devices is the verification of their safety and essential functioning, as the life and health of the patient may depend on the proper functioning of the device. It is the responsibility of the manufacturer to certify the conformity of the product, which requires the preparation of a documentation file, including protocols to demonstrate the safety of the product. For active medical devices, essential safety and essential performance requirements are defined in the IEC 60601, EN 60601 and MSZ 60601 series of standards.
Audio/video, information and communication technology equipment
The IEC/MSZ EN 62368-1 standard is a new product safety standard that replaces IEC 60065 "Audio-video and similar electronic apparatus" and IEC 60950 "Information technology equipment". The standard uses a new set of requirements and terminology and will be mandatory from December 2020.
Testing and evaluation of laboratory apparatus
IEC/MSZ EN 61010-1 is the current and widely accepted safety standard for electrical measuring, control and laboratory apparatus. Its wide range of applications covers a large segment of industry, such as in-vitro diagnostic equipment, machinery, heating and cooling equipment and programmable logic circuits. The hazards associated with the types of equipment are covered by product standards (IEC/MSZ EN 61010-2-x), which are to be used in conjunction with the IEC/MSZ EN 61010-1 basic safety standard. For example: IEC/MSZ EN 61010-2-101 specifies specific requirements for in-vitro diagnostic devices.
ConformiTICs Lab with its accredited testing laboratory is waiting for your partners!
CerTrust Ltd., TAM CERT Ltd. and SAASCO Ltd. have established ComformiTICs Lab Ltd. specialized in conformity assessment. Mr. Ágoston Loth was appointed general manager of the company.
The new laboratory conducts tests in accordance with standards at the site of the company in Váci út, Budapest, performed by technical experts who possess great proficiency and experience.
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