Medical Device Testing Standards

Dynatek’s products are designed to fulfill current and anticipated international regulations. Learn more about how our machines satisfy the following standards:
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  • ISO 5840-1:2015

  • ISO 5840-2:2015

  • ISO 5840-3:2013

  • ISO 7198:2016

  • ISO 12417-1:2015

  • ISO 14708-5:2010

  • ISO/TS 17137:2014

  • ISO 25539-1:2017

  • ISO 25539-2:2012

  • AAMI TIR42:2010

  • ASTM F2394 – 07(2017)

  • ASTM F2477-07

  • ASTM F2743-11

  • ASTM F3036-13

  • ASTM WK46148

  • ASTM WK60510
  • ASTM WK60511