Standards and Directives

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

Standards

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

Directives

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