BS EN ISO 14155 2011 Edition on Human Clinical Trials for Medical Devices just released

BS EN ISO 14155:2011, Clinical investigation of medical devices for human subjects — Good clinical practice, has just been released for public distribution.  The ISO 14155:2011 standard is adopted by the European Union for meeting the requirements of the Medical Device Directive (93/42/EEC).

BS EN ISO 14155 is the standard that specifies the 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 the responsibilities of the sponsor and principal investigator
  • Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.

It does not apply to in vitro diagnostic medical devices.

The document is identical to ISO 14155:2011, but does contain 2 informative annexes that are part of the EN administrative information regarding the adoption of the ISO standard.  These 2 annexes are:

Annex ZA:  Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices and

Annex ZB:  Relationship between this European Standard and the Essential Requirements of EU Directive 90/385/EECon active implantable medical devices

The principles set forth in BS EN ISO 14155 also apply to all other clinical investigations and should be followed as far as possible, depending on the nature of the clinical investigation and the requirements of national regulations.

The document withdraws and replaces two documents, BS EN ISO 14155-1 and BS EN ISO 14155-2, which are now obsolete.

The new BS EN ISO 14155 can be purchased on Document Center’s website, www.document-center.com, or by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com).  Should you have any questions about this document or any other standard, please get in touch.  Our expert staff is available to help you during business hours (8 am to 5 pm California time).