Medical Device Standards - quality management systems, risk and terminology

ISO 13485:2016 Advanced Access is here

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Medical Devices

According to the European Medical Device Directive (93/42/EEC), a medical device is:

"any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:

  • Diagnosis, prevention, monitoring, treatment or alleviation of disease
  • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
  • Investigation, replacement or modification of the anatomy or of a physiological process
  • Control of conception

... and which does not achieve its principle intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means . . ."

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Key Medical Device Standards

BS EN ISO 14971:2012 BS EN 60601-1-2:2015
BS EN ISO 14971:2012
BS EN 60601-1-2:2015
Medical devices. Application of risk management to medical devices Medical electrical equipment. General requirements for basic safety and essential performance. Collateral Standard. Electromagnetic disturbances. Requirements and tests
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