Welch Allyn SureTemp PlusModule - User Manual - Manual (Page 28)

OEM Responsibility SureTemp Plus Module OEM Implementation
28 Confidential Welch Allyn OEM Technologies
Table 5. Regulatory Test Descriptions and Standards
note Even though this manual provides the table as a guideline, the manufacturer of the host
system that integrates the SureTemp Plus module is responsible to make sure that the
host system and the host-supplied operator’s manual comply with all applicable
regulatory and safety requirements.
Test Description Standard
Electromagnetic Emissions EN 60601-1-2 section 36.201.1
Electromagnetic Compatibility EN 12470-3:2000 section 6.35
ESD EN 60601-1-2 section 36.202.2
Radiated EMI Susceptibility EN 60601-1-2 section 36.202.3
Magnetic Field Susceptibility EN 60601-1-2 section 36.202.8
Storage Tests ASTM E1112-00 section 4.3.2
EN 12470-3:2000 section 7.8 & section 6.3.4 humidity
Temperature shock - in use EN 12470-3:2000 section 7.9.2
Vibration Tests ISTA Procedure 1A
Thermal Response Time EN 12470-3:2000, section 6.2.4
Long-term Stability EN 12470-3:2000, section 6.2.6
Mechanical Shock EN 12470-3:2000, section 6.3.6
Drop Test EN 60601-1
Clinical test results
(including accuracy) Host responsibility