ALL STANDARDS OF OUR ELECTRICAL SAFETY LABORATORIES RELATED SERVICES Functional Safety in the Medical Industry Electromagnetic Compatibility (EMC) Testing Environmental Testing Nationally Recognized Testing Laboratories (NRTL) IECEE CB Scheme Contact us for med...
Why perform electrical safety tests? Electrical safety testing ensures medical equipment (ME) is electrically safe for use in a healthcare environment by testing for breakdown or damage. Medical device safety testing is more stringent when compared with generic electrical devices. Patients are signific...
Through our vast network of testing laboratories, we are able to provide you with a true “one-stop shop” for your medical electrical device testing needs. We can eliminate many of the headaches and hangups that occur when dealing with several different testing labs: ...
We offer unbiased third-party support in all areas of product development, from design consultancy, full product safety testing and completion of the Declaration of Conformity (DoC) to compilation and review of Technical Files. With top-notch expertise in electrical and electronic medical device testi...
General medical device testing: Medical Device Regulation 2017/745 (MDR) Regulation 2017/746 on in vitro diagnostic medical devices (IVDR). Electrical safety testing of medical devices: EN/IEC 60601-1: Infusomats/perfusers, ergometers, ultrasound (with tested sensors), operating theater monitors, ...
Element’s electrical safety testing can provide all the services a manufacturer needs to meet the requirements of the MDD. There are key aspects which are mandatory and these must be in place before CE marking to this Directive can take place, including: Product Safety Testing to show...
View our Medical Device Training Courses. View Our Services Biocompatibility Testing Assess the compatibility of medical devices with a biological system Learn More Electrical Safety Testing (IEC 60601) Testing is a critical step in the process of transforming an innovative design into a reliable and ...
Medical Device TechnologyBackes, John: "Safety Testing of Medical Devices: IEC 62353 Explained" European Medical Device Technology Magazine, 11/2007Beckes, J. (2007) Safety Testing of Medical Devices: IEC 62353 Explained. Available at emdt: http://www.emdt.co.uk/article/safety-testing-medical-...
STERIS assists in the evaluation and assessment of the safety, performance, and compliance of electrical devices utilized in healthcare settings.
Located in Devens, MA, and operating since 2018, Device Conformity and Testing, LLC is an ISO 17025:2017 accredited electrical safety test lab for medical devices testing to IEC 60601-1, and other industries by performing IEC 61010-1 testing, and SEMI S2 evaluations, EU Machinery and Low ...