Standards and Directives

Standards and Directives

PlazMax has been developed according to the following international standards and directives (partial list):


  • ISO 9001:2008
  • ISO 13485:2003
  • ISO 14937
  • EN 61010-2-040:2005
  • EN 60601-1:2006/AC:2010


  • Medical Device Directive 93/42/EC
  • CE Medical Device Mark 0344
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