Applied Standards
This product conforms to the provisions of the EC directive MDD (93/42/EEC). The following standards apply to design and/or manufacturing:
•ASTM E 1965- 98
Standard Specification for Infrared Thermometers for
Intermittent Determination of Patient Temperature
•EN 980: 2003
Graphical symbols for use in the labeling of medical devices
•IEC / EN
Medical electrical equipment
Part 1: General requirements for safety
•IEC / EN
Medical electrical equipment Part 2: Collateral standard:
Electromagnetic compatibility – Requirements and tests
•ISO 14971
Medical devices – Application of risk management to medical devices
•Classification according to IEC / EN
•Internally powered equipment
•IPX0
•NOT suitable for use in the presence of a flammable anesthetic mixture
•Continuous operation
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