
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
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