A “New Work Item Proposal” (NWIP) was recently submitted to ISO to prepare an international device standard for cerebral tissue oximeters. Linked to the general standard IEC 60601-1 “Medical electrical equipment”, this standard will cover particular requirements for basic safety and essential performance of cerebral tissue oximeter equipment. The NWIP was circulated to the national member bodies of the related standardization committees ISO/TC121/SC3 and IEC/TC62/SC62D. Provided their positive vote, the standard will be developed as an international effort by the ISO/IEC Joint Working Group (JWG) “Oximeters” within the next 2 years under the direction of Bob Kopotic as convenor.
This JWG is responsible for all non-invasive oximetry medical devices. Its members are experts nominated by their national committees. Currently, a revision of the pulse oximeter standard ISO/DIS 80601-2-61 is out for final vote. Last year, the standard for fNIRS devices was published, “IEC 80601-2-71:2015 Medical electrical equipment – Part 2-71: Particular requirements for the basic safety and essential performance of functional near-infrared spectroscopy (NIRS) equipment”.

For more information, contact: Alessandro Torricelli

Related links: ISO/TC121/SC3, IEC/TC62/SC62D.