Who it’s for
Who should attend
Hardware and software design engineers for active medical devices, systems engineers, human factors specialists, verification and validation engineers, and the regulatory and quality staff reviewing alarm system evidence.
Curriculum
Course modules
- Scope and purpose of IEC 60601-1-8; alarm fatigue and its clinical consequences
- Alarm system terminology and architecture
- Alarm conditions: physiological and technical
- Assigning alarm priority: high, medium and low
- Auditory alarm signals: characteristics, melodies and reserved sounds
- Visual alarm signals: colour, flashing rates and indicator requirements
- Informational signals and their separation from alarm signals
- Alarm limits and alarm presets
- Alarm paused, alarm off and audio paused states
- Distributed alarm systems and remote alarm signalling
- Alarm system logging
- Interfaces with ISO 14971 and IEC 62366-1
- Verification and test evidence
Outcomes
What you’ll be able to do
- Design an alarm system that conforms to IEC 60601-1-8
- Assign alarm priorities based on risk
- Produce the verification evidence required
How it works
Delivery, group size and what’s included
Delivery formats
On-site at your premises, live remote, or public open course.
Duration
The durations shown are minimums. Most courses run from 2 to 5 days, and longer or combined programmes can be arranged to suit the course and your requirements.
Group size
No minimum for remote or private on-site training. Public courses run with a minimum of 10 attendees. There is no fixed maximum; above 20 we normally split into groups, though this is open to discussion.
Assessment
Courses include an assessment.
Tailoring
Private training can be tailored to your products and your quality system. Where a course is tailored, specific documents may be requested in advance. Public courses are general in scope, though relevant worked examples are provided.
Languages
English and Italian. German and Russian available on request through an associate.
Included in the fee
- Full course slides (PDF)
- Workshops
- Practical exercises
- Case studies
- Open Q&A throughout
- Certificate of attendance (PDF), issued by ALPA Medical
- Up to 4 hours of post-course support
Get in touch
Enquire about “Alarms for Medical Devices”
Ask about dates, on-site or remote delivery, group size, or tailoring this course to your products and quality system.