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ASTM E1965-1998, EN 980: Graphical symbols for use in the labeling of medical devices, EN 1041:Information supplied by the manufacturer with medical devices, EN 60601-1: Medical electrical equipment Part 1: General requirements for safety (IEC:60601-1:1998), EN 60601-1-2: Medical electrical equipment Part 1-2: General requirements for safety Collateral standard Electromagnetic compatibility Requirements and test (IEC 60601-1-2:2001)

CE marked, RoHS compliant

FDA 501K Certified

FDA 510k exempt

FDA Cleared for OTC and Professional Use

FDA Cleared, CE RoHS Certified

IP54; CE

ISO 17025, NIST

ISO/IEC 17025:2005, A2LA, NIST, DKD, CE, RoHS

NIST

NIST Traceable

Reusable

Single-use

≥150 milliseconds

0.5 sec.

1 sec.

1 second

150 milliseconds

-27°F to +428°F

-4°F to +999°F

-58°F to +3362°F

50°F to 104°F

89.6°F to 108.5°F

93.2°F to 109.4°F

2 x AA, 3 V

2 x AAA

9 V

AAA

Alkaline