A new Standard for Clinical investigation of medical devices for human subjects – General requirements BS EN ISO 14155-1:2009 defines the procedures for the conduct and performance of clinical investigations of medical devices, where their clinical performance and safety is being assessed in people. The Standard is intended to protect people and to ensure the scientific conduct of the clinical investigation.
BS EN ISO 14155-1:2009 specifies:
- requirements for the organisation, conduct, monitoring, data collection, and documentation of the clinical investigation
- requirements that establish the performance of the device under conditions intended to mimic normal clinical use, thereby revealing adverse events in normal use and allowing the assessment of acceptable risks.
Reproduced with permission from the British Standards Institute 'Health and medical devices newsletter', January 2010.
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