What is the difference between IEC 62368 and 60950 ?

IEC 62368 and 60950 are two important international standards that manufacturers of electronic equipment must comply with to ensure the safety of their products. While both standards focus on the safety and performance of medical devices, there are significant differences between them.

IEC 62304, also known as " Essential Performance Requirements for Medical Electrical Equipment, " is primarily focused on software development and the ensuring of the safety and effectiveness of medical devices. It applies to various types of medical devices, such as pacemakers, insulin pumps, and blood glucose monitors. The standard requires medical device manufacturers to conduct comprehensive risk assessments, design safety measures into their devices, perform tests and inspections to validate compliance, and provide necessary documentation for regulators and users.

On the other hand, IEC 60950, also known as " Safety and Essential Performance Requirements for electrical equipment for the essential performance of medical devices, " is a broader standard that covers various aspects of safety requirements for medical electrical equipment. It applies to various types of medical devices, such as ventilators, monitors, and defibrillators. The standard requires medical device manufacturers to ensure that their devices meet various safety requirements, such as electrical safety, electromagnetic compatibility, mechanical safety, radiation protection, and software safety.

In summary, IEC 62368 and 60950 are both important standards that manufacturers must comply with to ensure the safety of their medical devices. While both standards focus on the safety and performance of medical devices, IEC 62304 is primarily focused on software development and the ensuring of the safety and effectiveness of medical devices, while IEC 60950 is a broader standard that covers various aspects of safety requirements for medical electrical equipment.