The medical industry is rapidly adopting new technology that enables better communication and performance of products & systems to improve the safety of care. Manufacturers today, face a number of compliance challenges, as devices that do not meet the highest quality and safety standards present, a risk of injury, recalls, bans and liability.
Electronic devices used in medical environments have important safety and performance requirements to ensure safety and compatibility with other critical care equipment.
As medical equipment continues to incorporate new electronic technology, the standard requirements have expanded to include new risk evaluations to verify your device does not present hazards to patient care.
The 60601 family of standards contains the essential requirements that your device must meet in order to be eligible for medical use. The requirements found in the 60601 standards include both safety and EMC testing to verify that devices do not interfere with nearby equipment and do not present unacceptable hazards to patients.
There are additional standards and regulations that may be applicable to medical devices, depending on your intended markets of sale. Examples of these may include AAMI or ASTM standards, CE marking requirements for the EU Medical Device Directive 93/42/ECC or FDA approval documentation under Title 21 of the Code of Federal Regulations (CFR).
MET is a one-stop-shop for EMC and safety testing for medical devices to verify compliance with major standards and international regulations.