Design for ISO testing compliance

Tests on electrical faults and compliance will also be done on the electrical components. This will ensure the safety of the users is guaranteed.
Tests on prototypes will involve tests on strength and stability, to ensure the device cannot cause harm during usage.
Tests on the strength of the mechanical system will also be done to ensure the hydraulic system is safe.
Tests on sterilization of the equipment will also be critical.

  1. IEC 60601-1:2005+AMD1:2012 CSV (consolidated version) This standard specifies requirements for electromedical devices; it has more than 60 related publications, that describe very specific areas of electromedical devices. Our product will comply with this ISO requirement
  2. EN 62304:2006+A1:2015 This standard specifies how to design and code software for medical devices and sets requirements for SW change control. Our product will comply with this ISO requirement