Acoustic Properties of Medical Devices

Purpose

Sound from medical devices and equipment affects patient safety, the work environment, and the user experience in healthcare and care settings. Functional sounds, such as alarms and monitoring signals, are intended to convey information and support patient safety. 

These sounds can negatively affect:

• the patient’s sense of security and comfort,
• healthcare staff’s concentration, communication, and fatigue levels.

In addition, the overall acoustic environment is influenced by background noise from, for example, fans, medical pumps, and other technical equipment, which is often perceived as disturbing.

At RISE, we support you in ensuring that sound from medical devices contributes to patient safety, a good working environment, and better user experience. Through our measurements and assessments for clinical and care-near environments, you receive a basis for developing both the product’s function and the overall acoustic environment in healthcare.

In our acoustic laboratory, we carry out independent testing and measurements of medical devices, and we also perform measurements and assessments in real clinical and care-near environments to provide you with a complete picture of the acoustic environment.

In addition to objective measurements, we can conduct listening tests and user-centered evaluations to assess how sound is perceived and how it affects healthcare staff and patients – giving you a basis for developing safer and more user-friendly products as part of risk management, usability, and product development.

Method

We measure and evaluate according to established methods and standards for sound, vibration, usability, and safety. The method is adapted to the product’s intended use, risk profile, and regulatory context – from early product development to verification, risk assessment, and documentation prior to certification or market access.

Depending on the question at hand, the work may include
•    measurement of the product’s sound power level, sound pressure level at the patient or caregiver position, and vibration emission
•    evaluation of alarm signals’ audibility and suitability for the intended environment
•    verification of sirens and alarm devices against applicable regulatory requirements.

Where relevant, we use established measurement methods, standards, and regulations, for example ISO 11201, ISO 3744, ISO 24501, EN 1789, relevant parts of the IEC/EN 60601 series, and VVFS 2003:29.
Measurements can be carried out both in a controlled laboratory environment and in real-use settings, such as ambulances, incubators, or other care-near environments. In this way, the results can be adapted to the product’s actual use and provide a relevant basis for product development, verification, risk assessment, or documentation.
The goal is to ensure that the products support a safe and appropriate sound environment, without unnecessarily burdening patients, staff, or users.

Deliverables

Our standard deliverable is test reports (in Swedish and/or English), tailored to regulatory and technical needs. If required, we can also provide statements, assessments, or supporting technical documentation and certification processes, depending on the scope of the assignment and the agreement.

We can also provide supporting material for CE marking under the MDR, as well as technical documentation and risk and usability analyses where sound and acoustic aspects are included.