What is BS EN 60601-1-2-2015 ?

What is BS EN 60601-1-2-2015 and EN 60601-1-2:2016?

BS EN 60601-1-2-2015 and EN 60601-1-2:2016 are both international standards for medical electrical equipment safety. BS EN 60601-1-2-2015 is the third edition of the standard, while EN 60601-1-2:2016 is the latest revision.

BS EN 60601-1-2-2015 provides general requirements for ensuring the safety and reliability of medical electrical equipment used in healthcare facilities. The standard covers various aspects, including electrical shock, mechanical hazards, radiation, and fire prevention.

EN 60601-1-2:2016, also known as IEC 60601-1-2, is an international standard that specifies the requirements and guidelines for the basic safety and essential performance of medical electrical equipment used in healthcare facilities. The primary aim of this standard is to ensure that medical electrical equipment does not interfere with other devices and systems and is immune to electromagnetic disturbances.

The key requirements of EN 60601-1-2:2016 include the presence of essential safety requirements, the risk assessment and risk management, and the documentation of the equipment design, verification, and testing. Compliance with this standard is essential for manufacturers, as it demonstrates compliance with essential safety requirements and helps manufacturers gain market access.

In conclusion, BS EN 60601-1-2-2015 and EN 60601-1-2:2016 are both important international standards for medical electrical equipment safety. Adhering to these standards is crucial for manufacturers, as it ensures compliance with essential safety requirements and helps manufacturers gain market access. Compliance with these standards is essential for the safety and reliability of medical electrical equipment used in healthcare facilities.