What is EN ISO 11681-5:2016?

EN ISO 11681-5:2016 is a technical standard that provides guidelines for the measurement and characterization of ultrasonic fields generated by medical diagnostic ultrasound equipment. This standard aims to ensure the safety and effectiveness of ultrasound imaging procedures.

The Importance of EN ISO 11681-5:2016

Ultrasound technology has become an essential tool in medical diagnostics, allowing healthcare professionals to visualize internal organs and tissues non-invasively. However, the potential risks associated with excessive exposure to ultrasound energy have raised concerns.

EN ISO 11681-5:2016 was established to address these concerns by providing standardized procedures for measuring and assessing the output of ultrasound equipment. By following this standard, manufacturers can ensure that their devices meet safety requirements, while healthcare professionals can use it as a guide to optimize imaging parameters and reduce patients' exposure to excessive ultrasound energy.

Main Provisions of EN ISO 11681-5:2016

This standard includes several important provisions to ensure the safe and responsible use of ultrasound equipment. One of the key elements is the specification of measurement procedures for determining various parameters, such as the spatial peak temporal average intensity (ISPTA) and the mechanical index (MI), which are indicators of the potential bio-effects of ultrasound exposure.

EN ISO 11681-5:2016 also provides guidelines for the characterization of ultrasound fields, including the determination of beam profiles and focal depth, as well as recommendations for performing quality assurance tests on the equipment. These measures aim to ensure that ultrasound devices produce reliable and repeatable results.

Conclusion

EN ISO 11681-5:2016 plays a crucial role in promoting the safe and effective use of medical diagnostic ultrasound equipment. By adhering to this standard, manufacturers can produce devices that meet stringent safety requirements, while healthcare professionals can optimize imaging procedures to minimize patients' exposure to potentially harmful ultrasound energy.

It is essential for all stakeholders in the field of medical ultrasound to familiarize themselves with EN ISO 11681-5:2016 and incorporate its guidelines into their practices to ensure the highest level of patient safety and quality care.