Blood Products: EP

  • EP 2.6.1 - Sterility
  • EP 2.6.8 - Pyrogens
  • EP 2.6.9 - Abnormal Toxicity
  • EP 2.6.14 - Bacterial Endotoxins
*These documents are available for purchase through the EDQM Website.

 

Blood Products: FDA & USP

FDA

USP*

  • USP<71> Sterility Tests
  • USP<85> Bacterial Endotoxins Test
  • USP<88> Biological Reactivity Tests, In vivo
  • USP<151> Pyrogen Test
*These documents are available for purchase through the The United States Pharmacopeial Convention.

 

Blood Products: ISO

  • ISO 11737-1: Sterilization of Medical Devices Microbiological Methods - Part 1: Determination of a Population of Microorganisms on Products
  • ISO 11737-2: Sterilization of Medical Devices Microbiological Methods - Part 2: Tests of Sterility performed in the Definition, Validation, and Maintenance of a Sterilization Process
*These documents are available for purchase through the The International Organization for Standardization.

 

Cell Line Characterization EMA & EP