ISO standard addresses medical device safety

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The International Standards Organization (ISO) has released ISO 14155:2011, an International Standard for assessing the safety and performance of medical devices, intended to protect patients and provide a technical basis for regulation while minimizing the technical barriers to trade.

ISO 14155:2011, “Clinical investigation of medical devices for human subjects – Good clinical practice,” addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out on human subjects to assess the safety or performance of medical devices for regulatory and other purposes, according to the ISO, which is a network of standards institutes of more than 150 countries, with a central secretariat in Geneva.

More than one million accidents attributable to medical devices occur annually in the U.S., the World Health Organization (WHO) reported, and in some developing countries, as much as 50 percent of medical equipment is unusable or only partly usable.

This standard specifies general requirements intended to:

  • Protect the rights, safety and well-being of human subjects;
  • Ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results;
  • Define responsibilities of the sponsor and principal investigator; and
  • Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in medical device conformity assessment.