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

What is BS EN 60601-1-2:2016 and EN 60601-1:2020?

BS EN 60601-1-2:2016 and EN 60601-1:2020 are both international standards for medical electrical equipment. BS EN 60601-1-2:2016 is also known as IEC 60601-1-2 and is an international standard for the basic safety and essential performance of medical electrical equipment used in healthcare facilities. It provides requirements and guidelines for the equipment's performance while immune to electromagnetic disturbances.

EN 60601-1:2020, on the other hand, is the latest version of the standard and is an international standard developed by the International Electrotechnical Commission (IEC). It focuses on the safety and essential performance requirements of medical electrical equipment and systems. The primary objective of this standard is to ensure the safety of both patients and healthcare professionals.

Key Requirements of EN 60601-1-2:2016

EN 60601-1-2:2016 provides manufacturers with guidelines to design, manufacture, and test their medical electrical equipment while considering the potential hazards and risks associated with their use. The key requirements of this standard include:

Compatibility with other medical devices: EN 60601-1-2:2016 ensures that medical electrical equipment is compatible with other devices and systems used in healthcare facilities.

Safety: The standard provides requirements for the safety of patients, healthcare professionals, and others who may be in close proximity to medical electrical equipment.

Electrical safety: EN 60601-1-2:2016 ensures that medical electrical equipment is designed and manufactured to minimize the risk of electrical shock or other electrical hazards.

Environmental protection: The standard requires medical electrical equipment to be designed and manufactured to protect from environmental factors such as moisture, dust, and extreme temperatures.

Maintenance and testing: EN 60601-1-2:2016 specifies the testing and maintenance requirements for medical electrical equipment to ensure that it continues to meet the requirements of the standard.

EN 60601-1:2020

EN 60601-1:2020 is a more comprehensive standard that takes into account advancements in technology, emerging risks, and changes in regulatory requirements. It provides manufacturers with guidelines to design, manufacture, and test their medical devices while considering the potential hazards and risks associated with their use.

The primary objective of EN 60601-1:2020 is to ensure the safety of both patients and healthcare professionals. It provides advanced safety features such as:

Anticipating and mitigating risks: EN 60601-1:2020 encourages manufacturers to anticipate and mitigate risks associated with medical electrical equipment.

Incorporating new technologies: The standard encourages manufacturers to consider new technologies that can improve the safety of medical electrical equipment.

Enhanced user control: EN 60601-1:2020 provides users with more control over medical electrical equipment, allowing them to make changes to the equipment's design and configuration.

Greater emphasis on testing: The standard requires manufacturers to conduct more thorough testing of medical electrical equipment, including testing for new risks and technologies.

Conclusion

BS EN 60601-1-2:2016 and EN 60601-1:2020 are both important international standards for medical electrical equipment. They provide manufacturers with guidelines to design, manufacture, and test medical devices while considering the potential hazards and risks associated with their use. EN 60601-1:2020 offers more advanced safety features and emphasizes testing.