Which is a common standard for medical device safety testing?

IEC 60601 is a widely recognized standard that specifically pertains to the safety and effectiveness of medical electrical equipment. It sets forth the general requirements for basic safety and essential performance of medical devices, ensuring that they are safe for use in healthcare environments. This standard covers aspects such as electrical safety, mechanical safety, and electromagnetic compatibility, which are critical in preventing harm to patients and healthcare providers.

ISO 9001, while important for quality management systems, does not specifically address the safety of medical devices. Similarly, ASTM D638 pertains to the testing of plastics and their properties, which is not focused on medical device safety. ANSI Z535 is related to safety signs and symbols, which helps in communication of hazards but does not cover the technical safety standards for medical devices. Therefore, IEC 60601 is the most relevant and directly connected to medical device safety testing.