Category ""
ADVERTISING
Gain a basic understanding of the IEC 60601-1-8 technical standard for medical alarms, including key requirements, component guidelines, and alarm tone specifications.
In this blog, we will review the general outline of IEC 60601-1-8 and the key requirements given for audible alarms in medical equipment as well as providing example medical buzzer tones. What is IEC 60601-1-8?
The IEC 60601-1-8:2006 lists the requirements for an alarm system in medical equipment. In medical equipment like neonatal incubators, the visual and auditory alarms can act as complementary alerts.
There are currently two active versions: IEC 60601-1-8 AMD1 and IEC 60601-1-8 AMD2:2020. The cut-off date for IEC 60601-1-8 AMD1 is December 17, 2023, per the supplemental information sheets from the FDA web-based directory of consensus standards.
A brief overview of the IEC 60601-1-8 standard in regards to audible alarms and good solutions that satisfy this standard.
The medical alarms are designed to comply with the IEC 60601-1-8 standard for audible medical alarms. The IEC standard seeks to improve patient safety by standardizing medical audible and visual alarms.
If your device produces visual or audible signals with the intent to mitigate risk (reduce the probability of occurrence of harm) you are using an alarm system and it is highly recommended that you follow 60601-1-8.
available on ideal alarm characteristics, the IEC (International Electrotechnical Commission) has provided the first focused standard on audible and visual alarms for medical equipment, the IEC60601-1-8.
The IEC 60601-1-8 standard details the necessary alarm-related elements for these systems including a primary alarm, a redundantly powered backup alarm, and a visual alarm indicator.
The definitions of "alarm system" and "alarm condition" in IEC 60601-1-8 are not really tight enough to exclude an information message, since it is still to indicate a potential hazard. It appears the scope statement (Clause 1.1) that the decision to use an "alarm system" is up to the manufacturer.