Applied standards – Lumiscope 2220 User Manual

Page 13

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