Medical Device Standards - quality management systems, risk and terminology

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 . . ."

ISO 13485:2016

The world's most popular standard for medical devices quality management


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Current Standards for Healthcare & Medical Devices

Key Standards

BS EN 285:2015 BS EN 60601-1-11:2015
BS EN 285:2015
BS EN 60601-1-11:2015
Sterilization. Steam sterilizers. Large sterilizers Medical electrical equipment. 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
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ISO 13485

The world's most popular standard for medical devices quality management