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PlazMaxStandards and Directives

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PlazMax has been developed according to the following international standards and directives:

Standards

  • NP EN ISO 9001:2000
  • EN ISO 13485:2003
  • EN ISO 14937
  • EN 61010-2-040
  • EN 61010-2-042

Directives

  • 73/23/EEC
  • 89/336/EEC
  • 98/37/EEC
  • 93/42/EEC
  • CE Medical Device Mark 0344