ISO 16142 Medical Devices - Standard Test for Accepted Basic Principles for the Safety and Performance of Medical Devices

EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of ISO 16142 testing. ISO 16142, which includes the fundamental principles of safety and performance, defines important standards and guidelines that can be used in evaluating the conformity of a medical device with accepted fundamental principles, demonstrates and performs that a medical device is safe when met. ISO 16142 defines and describes six general key safety and performance principles that apply to all medical devices, including IVD medical devices (in vitro diagnostics).

ISO 16142 also defines and describes additional key safety and performance principles for non-IVD medical devices that must be considered during the design and manufacturing process. The future ISO 16142‑2 aims to define and define key safety and performance principles that must be considered in the design and manufacturing process of IVD medical devices.

ISO 16142 is designed to be used as a guide by medical device manufacturers, standards development organizations, competent authorities and conformity assessment bodies.

Standards and standardization processes can be made more effective by better understanding the needs and requirements of those who use or are affected by the standards. Improvements in standards will contribute to global compliance efforts at all levels.

Continuous innovation is key to the advancement of medical device technology that contributes to more effective healthcare. Ideally, standards that support or reference regulatory requirements are developed and implemented by industry to allow product innovation while ensuring safety and effectiveness.

Timely development and periodic revisions of medical device standards make medical device standards effective and efficient tools to support regulatory systems and achieve harmonized regulations globally.

EUROLAB assists manufacturers with ISO 16142 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.