BS EN IEC 61847:2025 Ultrasonics. Surgical Systems

Measurement and Declaration of the Basic Output Characteristics

Introducing the BS EN IEC 61847:2025, a comprehensive standard that sets the benchmark for ultrasonics in surgical systems. This standard is essential for professionals in the medical field who are involved in the design, implementation, and maintenance of ultrasonic surgical equipment. Released on July 17, 2025, this document is the latest in a series of standards that ensure the highest level of safety and performance in medical ultrasonic devices.

With a total of 40 pages, this standard provides detailed guidelines and specifications for the measurement and declaration of the basic output characteristics of ultrasonic surgical systems. It is a critical resource for manufacturers, engineers, and healthcare providers who are committed to maintaining the integrity and efficacy of surgical procedures that utilize ultrasonic technology.

Key Features of BS EN IEC 61847:2025

• Standard Number: BS EN IEC 61847:2025
• ISBN: 978 0 539 21162 7
• Status: Standard
• Release Date: July 17, 2025
• Total Pages: 40

The BS EN IEC 61847:2025 standard is meticulously crafted to address the complexities and nuances of ultrasonic surgical systems. It provides a framework for the accurate measurement of output characteristics, ensuring that these systems operate within safe and effective parameters. This is crucial for minimizing risks and enhancing the outcomes of surgical procedures.

Why Choose BS EN IEC 61847:2025?

The adoption of this standard is a testament to a commitment to excellence and safety in the medical field. By adhering to the guidelines set forth in BS EN IEC 61847:2025, healthcare facilities and manufacturers can ensure that their ultrasonic surgical systems are compliant with the latest industry standards. This not only enhances the safety of surgical procedures but also boosts the confidence of patients and healthcare providers alike.

Furthermore, the standard facilitates international harmonization, making it easier for products to be accepted in global markets. This is particularly beneficial for manufacturers looking to expand their reach and establish a presence in new regions.

Comprehensive Coverage

The BS EN IEC 61847:2025 standard covers a wide range of topics related to ultrasonic surgical systems. It includes detailed instructions on the measurement of output characteristics, ensuring that all aspects of the system's performance are thoroughly evaluated. This comprehensive approach helps to identify potential issues before they can impact patient safety or the effectiveness of surgical procedures.

In addition to measurement guidelines, the standard also provides recommendations for the declaration of output characteristics. This ensures that all relevant information is communicated clearly and accurately, facilitating better decision-making by healthcare providers and enhancing the overall quality of care.

Enhancing Patient Safety and Care

At the heart of the BS EN IEC 61847:2025 standard is a commitment to patient safety and the enhancement of care quality. By providing a clear and consistent framework for the measurement and declaration of ultrasonic surgical system characteristics, this standard helps to ensure that these systems are used safely and effectively in clinical settings.

The standard's emphasis on accurate measurement and clear communication of output characteristics is particularly important in the context of surgical procedures, where precision and reliability are paramount. By adhering to the guidelines set forth in BS EN IEC 61847:2025, healthcare providers can minimize risks and improve patient outcomes.

Conclusion

The BS EN IEC 61847:2025 standard is an indispensable resource for anyone involved in the design, implementation, or maintenance of ultrasonic surgical systems. Its comprehensive guidelines and specifications ensure that these systems operate safely and effectively, enhancing the quality of care and patient safety.

By adopting this standard, healthcare facilities and manufacturers can demonstrate their commitment to excellence and safety, while also facilitating international harmonization and expanding their reach in global markets. The BS EN IEC 61847:2025 is more than just a standard; it is a pathway to better, safer, and more effective surgical care.

BS EN IEC 61847:2025

This standard BS EN IEC 61847:2025 Ultrasonics. Surgical systems. Measurement and declaration of the basic output characteristics is classified in these ICS categories:

• 11.040.50 Radiographic equipment
• 11.040.01 Medical equipment in general
• 17.140.50 Electroacoustics

IEC 61847:2025 specifies: – the essential non-thermal output characteristics of ultrasonic surgical units; – methods of measurement of these output characteristics; – those characteristics to be declared by the manufacturers of such equipment. This document is applicable to equipment which meets the criteria of a), b) and c) below: a) ultrasonic surgical systems operating in the frequency range 20 kHz to 120 kHz; and b) ultrasonic surgical systems whose use is the fragmentation, emulsification, debridement, or cutting of human tissue, whether or not those effects are delivered in conjunction with tissue removal or coagulation; and c) ultrasonic surgical systems in which an acoustic wave is conducted by means of a specifically designed wave guide to deliver energy to the surgical site. This document is not applicable to: – lithotripsy equipment which uses extracorporeally induced pressure pulses, focused through liquid conducting media and the soft tissues of the body; – surgical systems used as part of the therapeutic process (hyperthermia systems); – surgical systems whose mechanism of action is through frictional heat generated by tissue in contact with the wave guide, e.g. clamp coagulators or clamping vibrational cutters; – surgical systems whose mechanism of action is through focused ultrasound for either thermal degradation (high intensity focused ultrasound – HIFU or HITU) or cavitation erosion (Histotripsy) of tissue remote from the ultrasound transducer; – surgical systems whose mechanism of action is through erosion of hard tissues in contact with the applicator tip, e.g. bone cutting or drilling. This document does not deal with the effectiveness or safety of ultrasonic surgical systems. This document does not deal with airborne noise from the systems, which can affect operators and patients. IEC 61847:2025 cancels and replaces the first edition published in 1998. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) The upper frequency covered by this document has been raised from 60 kHz to 120 kHz. b) The hydrophone method of measuring ultrasound power is now normative. Because of difficulties in using the calorimetry method of measuring ultrasound power, it is no longer the primary approach. c) It is recognised that some systems can have more than one mode of vibration under user control, and the measurement techniques and declarations have been updated to address this. d) The high-frequency component, which relates to cavitation developed at the applicator tip and the vibration amplitude at which cavitation occurs is addressed. e) Specific requirements for measurement at excursion levels where no cavitation is present, and extrapolation to maximum excursion level(s) are described. f) Guidance is provided to adapt the methodology described to more complex designs and vibration patterns, excursion directions, and their output characteristics. g) Guidance is provided with respect to measurement tank arrangements for different types of systems. h) The list of ultrasound methods and systems not covered by this document was extended to incorporate recent developments. i) Definitions for cavitation related terms were added. j) Requirements for the measurement of directivity characteristics of the applicator tip were changed. k) Annex A was modified and Figure A.1 wa