IEC 60601-1 - Medical Electrical Equipment Safety
Clauses 9 to 10: mechanical and radiation hazards – IEC 60601-1 - Medical Electrical Equipment Safety

IEC 60601-1 - Medical Electrical Equipment Safety 9.6: Acoustic energy (including infra- and ultrasound) and vibration

What does 9.6 require?

People exposed to the equipment's vibration and acoustic energy face no unacceptable risk, allowing for the audibility of alarm signals and patient sensitivity: in normal use nobody is exposed to more than 80 dBA over 24 hours (3 dBA higher for each halving of exposure time) or 140 dBC peak for impulsive noise, excluding auditory alarm signals, measured as the highest A-weighted level at the closest positions the operator, the patient and other people take under worst-case normal condition with protective means in place, with IEC 61672 meters, in a semi-reverberant room with a hard floor and at least 3 m to walls, or in situ for large permanently installed equipment; infrasound and ultrasound risks are addressed in the risk management process where applicable; and except for vibration the intended use requires, protection is provided where hand-transmitted frequency-weighted acceleration exceeds 2.5 m/s squared for 8 hours in 24 (scaling with one over the square root of time), measured per ISO 5349-1 at points of hand contact.

Maintained by Gerard BlokdykControl text last updated

Other controls in Clauses 9 to 10: mechanical and radiation hazards – IEC 60601-1 - Medical Electrical Equipment Safety

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.