Test standards for bioburden

  • DIN EN ISO 11737-1 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products.
     
  • Ph. Eur. 8, 2.6.12 European Pharmacopoeia, 8, 2.6.12 – Testing of microbial contamination in non-sterile products: Counting of total viable aerobic germs – B = Harmonized testing method.
     
  • Ph. Eur. 8, 5.1.4 European Pharmacopoeia, 8, 5.1.4 – Microbiological quality of non-sterile pharmaceutical preparations and of substances for pharmaceutical use.
     
  •  USP 38 <61> Microbiological Examination of nonsterile products: microbial enumeration tests.
     
  • USP 38 <1111> Microbiological Examination of nonsterile products: acceptance criteria for pharmaceutical preparations and substances for pharmaceutical use.
     
  • JP 16, 4.05 I Microbiological Examination of Non-Sterile Products: Microbial Enumeration Tests