What is the difference between IEC 60950-1 and IEC 62368-1 ?

iec 60950-1 and iec 62368-1 are two important standards that relate to the safety of medical electrical equipment. While both standards aim to ensure the safety of medical electrical equipment, there are some key differences between them.

Scope:

IEC 60601 applies to all stages of a device's life cycle, from design to end-of-life, while IEC 62353 focuses on in-service testing. IEC 60601 provides guidelines for establishing safety and performance requirements for medical electrical equipment, while IEC 62353 provides guidelines for assessing compliance through testing.

Testing Intervals:

The main objective of IEC 60601 is to identify any potential hazards or malfunctions in medical electrical equipment and take appropriate actions to mitigate the risks. IEC 62353 prescribes periodic testing intervals to assess the electrical safety of medical devices. It covers various tests, including visual inspections, functional checks, and electrical measurements.

Routine Testing and Type-Testing:

While IEC 60601 focuses on establishing safety and performance requirements for medical electrical equipment, IEC 62353 is centered around testing the safety of these devices. IEC 62353 provides guidelines for both routine testing and type-testing of medical electrical devices. Routine testing involves regular checks to ensure the ongoing safety and reliability of the equipment, while type-testing is performed during the development and certification stages to verify compliance with safety requirements.

Conclusion:

In conclusion, IEC 60950-1 and IEC 62353 are both important standards related to the safety of medical electrical equipment. While both standards aim to ensure the safety of medical electrical equipment, IEC 62353 is focused on in-service testing, while IEC 60601 focuses on establishing safety and performance requirements for medical electrical equipment. By understanding the differences between these two standards, manufacturers can ensure that their medical electrical equipment meets the necessary safety and performance requirements.