Hospital Equipment
Ward and theatre equipment that runs for years and must not fail quietly. Electrical safety, alarms, serviceability and continuous duty set most of the design.
- Devices we have built here
- Ventilators, oxygen concentrators, OT video recorders, Auto CPAP, organ transportation, blood warmers.
Devices we have worked on
We name the type of device, not the client. Client work stays confidential.
- Blood and fluid warmer, in two flow ranges
- Whole-body patient warming pad system
- Organ transport system
- Membrane oxygenator for cardiopulmonary bypass
What makes these devices hard
Continuous duty
Equipment runs for hours or days and must not fail quietly.
Alarms
What the device warns about, how loudly and how a nurse silences it.
Electrical safety
Insulation, leakage current and earthing, fixed in the architecture.
Service life
Access for service, spare parts and a maintenance schedule over years.
Tell us these first
Useful in a first enquiry
- The setting: ward, ICU, operating theatre or transport
- What the device must keep doing if something fails
- Mains, battery or both, and the battery run time
- Who operates, cleans and services it
- Products you replace or benchmark against
Essential performance decides the alarms
IEC 60601-1 asks the manufacturer to name the device's essential performance: the functions whose loss would create an unacceptable risk. That list drives the alarms. Each alarm condition gets a priority from the risk analysis, and IEC 60601-1-8 sets how high, medium and low priority signals look and sound. Name essential performance early, because EMC and safety tests must also show it is kept.
The path for a device like yours
Questions about hospital equipment
What is essential performance?
The performance whose loss or degradation would create an unacceptable risk, for example holding a set temperature or flow. IEC 60601-1 asks you to name it, and your alarms and tests are built around it.
Do we need a particular standard as well as IEC 60601-1?
Often. Many device types have a particular standard in the IEC 60601-2 or 80601-2 series, such as IEC 80601-2-35 for heating pads and blankets. Where the two differ, the particular standard takes precedence.
Which class will our equipment be?
The class follows the intended use and the classification rules, not the equipment type. Try the class and route tool.
When should EMC testing start?
Pre-compliance checks on early boards find problems while the layout can still change. Formal testing to IEC 60601-1-2 comes on the final design.
Hospital programmes on record
Our programmes include a blood and fluid warmer in two flow ranges, a whole-body patient warming pad system, an organ transport system and a membrane oxygenator for cardiopulmonary bypass.
Standards that commonly apply
- IEC 60601-1Basic safety and essential performance
- IEC 60601-1-2Electromagnetic disturbances
- IEC 60601-1-8Alarm systems
- IEC 62366-1Usability engineering
- IEC 80601-2-35Heating devices using blankets, pads or mattresses
The list for a given device, and the edition of each, is set in its regulatory plan.
Services that help here
Building a device in Hospital Equipment?
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