- Palabras clave > availability, affordability, quality and safety - medical devices
- Palabras clave > electrical and electronic medical devices
- Palabras clave > laboratory testing
- Palabras clave > medical devices - safety
- Palabras clave > medical devices - testing laboratory/facility
- Palabras clave > medical devices (MD)
- Palabras clave > tests, methods, and general requirements
(2015; 52 pages)
Medical Devices form an important component of patient care. From tongue depressor to dialysis machine, medical devices encompass a very broad and complex variety of technologies. The complexities are coupled with presence of power factors in most medical devices. Thus, apart from performance the crucial aspect of devices safety, patient safety and health provider’s safety gets incorporated. In order to comply with all safety requirements, sets of universal standards and norms have been prescribed, compliance to which ensures delivery of right technology in the right way. A means to verify the devices against this desired compliance is testing. Thus, product testing brings into existence the first level of assessment of appropriateness and safety of a devices.
Since devices have a very broad range, so are tests and testing requirements for safety. However, all electrical and electronic devices that deal with electrical power and electromagnetic interference have a common set of prescribed tests and standards. This report highlights the basic requirements, work flow, infrastructure and human resources required for establishing medical device testing laboratory/ facility for testing of electrical and electronic medical devices.