Graco Ear Thermometer Owner's Manual page 16

Applied standards and approvals
This product conforms to the provisions of the EC
directive MDD(93/42/EEC).
The following standards apply to design and/or
manufacturing of the products:
• ASTM E1965-98: Standard Specification for
infrared thermometers for intermittent
determination of patient temperature.
• IEC/EN980:1997: Graphical symbol for use in
the labeling of medical devices.
• IEC/EN60601-1: Medical electrical equipment
– Part 1: General requirement for safety.
• IEC/EN60601-1-2: Medical electrical equipment
– Part 2: Collateral standard: Electromagnetic
compatibility – Requirements and tests.
• ISO 14971 Risk Management
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