What is the difference between IEC 60950 and 62368 ?

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

IEC 62304, also known as "Code of Practice for Medical Equipment," is primarily focused on software development for medical devices. It outlines best practices for the development, testing, and validation of medical software, including requirements for documentation, labeling, and user interfaces.

In contrast, IEC 60601, also known as "Medical electrical equipment - Safety requirements," covers a broader range of safety requirements for medical electrical equipment. It applies to various types of medical devices that rely on electrical power, such as diagnostic equipment, therapeutic devices, and monitoring systems.

The primary objective of IEC 60601 is to ensure that these medical devices do not pose any potential hazards to patients, operators, or any other individuals who come in contact with them. The standard covers various aspects, including electrical safety, electromagnetic compatibility, mechanical safety, radiation protection, and software safety.

IEC 60601 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. In addition, the standard requires manufacturers to ensure that their products meet certain performance requirements, such as stability, reliability, and performance under various environmental conditions.

In summary, IEC 62304 is focused on software development for medical devices, while IEC 60601 covers a broader range of safety requirements for medical electrical equipment. Both standards are important for ensuring the safety of electronic equipment, but they focus on different aspects of the product development process.