Subject to change without notice.
This appliance conforms to the following standards:
Standard Reference Edition Title:
EN 12470-5: 2003 Clinical thermometers – Part 5: Performance of infra-red ear thermometers (with
maximum device).
EN 60601-1: 2006 Medical electrical equipment – Part 1: General requirements for basic safety and
essential performance.
EN ISO 14971: 2012 Medical devices – Application of risk management to medical devices.
EN ISO 10993-1: 2009 Biological evaluation of medical devices – Part 1: Evaluation and Testing within
a risk management process.
EN 60601-1-2: 2007 Medical electrical equipment – part 1-2: General requirements for basic safety and
essential performance
Collateral standard: electromagnetic compatibility
Requirements and tests
EN 980: 2008 Symbols for use in labeling of medical devices.
EN 1041: 2008 Information supplied by the manufacturer of medical devices.
EN 60601-1-11: 2010 Medical electrical equipment — Part 1-11: General requirements for basic safety
and essential performance — Collateral standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare environment.
This product conforms to the provisions of the EC directive 93/42/EEC.
MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC. For detailed description
of EMC requirements please contact Customer Service.
Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL EQUIPMENT.
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