What is the difference between IEC 60601-1 and 60601 2 ?

IEC 60601 and IEC 60601 2 are both international standards for medical electrical equipment, but they have different focuses and requirements. IEC 60601 is an international standard published by the International Electrotechnical Commission (IEC) that provides guidelines for the safety and performance of medical electrical equipment. It is primarily applicable to medical devices intended for use within the European Union and has a more comprehensive scope than EN 60601.

On the other hand, IEC 60601 is a standard specific to medical electrical equipment used in healthcare settings. It focuses on the safety requirements and performance of medical devices and sets standards for medical electrical equipment in terms of electrical safety, electromagnetic compatibility, usability, and essential performance.

One of the main differences between the two standards is the geographical scope. The EN 60601 is primarily applicable to medical devices intended for use within the European Union, while the 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, the 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.

IEC60601 is a standard specific to medical electrical equipment and focuses on the safety requirements and performance of medical devices used in healthcare settings. It sets standards for medical electrical equipment in terms of electrical safety, electromagnetic compatibility, usability, and essential performance. The standard considers factors such as patient safety, the prevention of electrical shock, the mitigation of hazards related to mechanical and functional failures, and the accuracy of measurements taken by medical devices.

In conclusion, IEC 60601 and IEC 60601 2 are both international standards for medical electrical equipment, but they have different focuses and requirements. IEC 60601 is a specific standard for medical electrical equipment used in healthcare settings, while IEC 60601 is an international standard for medical electrical equipment in general. Manufacturers must ensure compliance with the specific requirements of each standard to target both EU and international markets.