What is EN ISO 14145-2:2021?

EN ISO 14145-2:2021 is a professional technical standard that provides guidelines for the measurement and characterization of ultrasonic fields generated by medical diagnostic and therapeutic devices. It was developed by the International Organization for Standardization (ISO) and the European Committee for Standardization (CEN).

Scope and Purpose

The scope of EN ISO 14145-2:2021 includes the measurement and characterization of the acoustic output of medical ultrasound equipment in order to ensure safety and performance standards are met. This standard applies to all types of medical ultrasound devices, including diagnostic ultrasound systems, therapeutic ultrasound systems, and any other devices that produce ultrasonic fields for medical purposes.

The purpose of this standard is to provide consistent and reliable measurements of ultrasonic fields produced by medical devices. By following the guidelines outlined in EN ISO 14145-2:2021, healthcare professionals can assess and compare the performance of different ultrasound equipment, as well as ensure patient safety by minimizing potential hazards associated with excessive exposure to ultrasound waves.

Main Requirements

EN ISO 14145-2:2021 specifies the requirements for the test objects, instrumentation, procedures, and documentation required to measure and characterize ultrasonic fields. Some of the key requirements include:

Use of standardized test objects to simulate human tissue

Calibration and verification of measuring instruments

Measurement of output characteristics, such as beam profile, spatial peak-temporal average intensity, and frequency spectrum

Evaluation of potential bioeffects based on the measured values

Documentation and reporting of measurement results

Importance in the Medical Field

EN ISO 14145-2:2021 plays a crucial role in ensuring the safety and effectiveness of medical ultrasound devices. By complying with this standard, manufacturers can demonstrate that their equipment meets the necessary performance and safety criteria, giving healthcare professionals confidence in using these devices for diagnostic and therapeutic purposes.

Furthermore, adherence to EN ISO 14145-2:2021 allows for consistent measurements and comparisons of different ultrasound systems, enabling healthcare providers to make informed decisions when selecting and purchasing medical ultrasound equipment. This standard ultimately helps to protect patients from potential risks associated with improper use or malfunction of ultrasonic devices.

In conclusion, EN ISO 14145-2:2021 provides essential guidelines for the measurement and characterization of ultrasonic fields produced by medical devices. Compliance with this standard ensures the safety and reliability of medical ultrasound equipment, benefiting both healthcare professionals and patients in the field of medical diagnostics and therapy.