Applied standards – Lumiscope 2220 User Manual
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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 60601-1
Medical electrical equipment
Part 1: General requirements for safety
• IEC / EN 60601-1-2
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 60601-1:
• Internally powered equipment
• IPX0
• NOT suitable for use in the presence of a
flammable anesthetic mixture
• Continuous operation