ECC’s Board amended Recommendation N 17 (from 04/09/2017).

The Recommendation lists standards that set safety requirements for medical products and devices in the EAEU.

Changes to the document include:

  • Addition of standards introduced during 2020 – 2022 (such as GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices, GOST IEC 62304-2022 Medical devices. Software. Life cycle processes)
  • Removal of standards expired after 2019.

Recommendation N 17 includes standards applied during the confirmation of conformity procedures. The list consists of both mandatory and voluntary standards.