TS EN60601-1-12
What Is TS EN 60601-1-12?
TS EN 60601-1-12 is an international standard developed to ensure that electronic medical equipment can operate safely and effectively in emergency care environments. It is a collateral standard to IEC 60601-1 and establishes requirements that support durability, reliability, and essential performance.
Why Is It Important?
Equipment used in emergency medical services often operates in uncontrolled and demanding conditions, such as ambulances, helicopters, field hospitals, and emergency departments. These environments can introduce significant risks to patient and operator safety as well as to device performance.
TS EN 60601-1-12 defines test criteria to help ensure safe and reliable operation under the following conditions:
- High / low temperatures
- High humidity
- Exposure to vibration and shock
- Transportation and storage conditions
Scope
This standard covers performance and safety testing for the following types of medical devices intended for emergency use:
- Portable ventilators
- Defibrillators
- Patient monitors
- Other emergency-use medical devices
What Is Evaluated During Testing?
- Temperature and Humidity Tests: Operability from −20 °C to +50 °C
- Vibration and Shock Tests: Suitability for ambulance and helicopter transport
- Mechanical Robustness: 1 m drop tests
- Storage Conditions: Long-term endurance at high/low temperature and humidity
