What is the difference between EN 60601 and IEC 60601 ?

EN 60601 and IEC 60601 are both international standards for medical electrical equipment, but there are differences between the two. EN 60601 is an international standard published by the International Electrotechnical Commission (IEC) and is primarily applicable to medical devices intended for use within the European Union. IEC 60601 has a broader reach and applies to medical equipment used internationally.

One of the main differences between the two standards is the geographical scope. EN 60601 is primarily applicable to medical devices intended for use within the European Union, while IEC 60601 has a broader reach and applies to medical equipment used internationally. However, it's important to note that many countries outside the EU choose to adopt the EN 60601 as their national standard.

In terms of technical requirements, EN 60601 and IEC 60601 share similarities but also have some variations. These differences can encompass specific performance criteria and testing methods, as well as varying limits for electromagnetic interference and safety measures. Therefore, manufacturers targeting both EU and international markets must ensure compliance with the specific requirements of each standard.

IEC 60601 is an international standard developed by the International Electrotechnical Commission (IEC). It sets the benchmark for the safety and essential performance of medical electrical equipment worldwide. The scope of IEC 60601 encompasses not only electrical safety but also general performance requirements related to mechanical strength, effectiveness of controls and displays, accuracy of measurements, and resistance to environmental conditions. It also includes provisions for risk management, usability, and overall system performance evaluation.

While there are similarities between EN60601 and IEC60601, there are some notable differences as well. The most significant difference lies in the scope of application. EN60601 is specific to Europe, while IEC60601 has global applicability.

Another difference is with respect to the variations in testing and certification processes. Compliance with EN60601 requires additional conformity assessment procedures, such as the CE marking, which indicates compliance with European health, safety, and environmental protection standards. On the other hand, IEC60601 generally follows a simpler certification process without such additional requirements.