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Compliance with standards
The sensor conforms to the requirements of the quality standard DS/EN ISO 13485 and the
council directive 93/42/EEC (amended) concerning medical devices.
The sensor is manufactured by Braemar and the sensor meets the following standards and
regulations:
•
IEC 60601-1 ed 3.1 Consol. With am1 (2012) Medical electrical equipment – Part 1: General
requirements for basic safety and essential performance
•
EN 60601-1-2:2007 Collateral standard: Electromagnetic compatibility – Requirements
and tests
•
EN 62366:2008 Application of usability engineering to 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
•
IEC 60601-2-47:2012 Medical electrical equipment – Part 2-47: Particular requirements for
the basic safety and essential performance of ambulatory electrocardiographic systems
• DS/EN ISO 14971:2007 Medical devices – Application of risk management to medical devices
CardioNet, LifeWatch, and BioTel Heart are trademarks of
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