[Determination of the microporosity and the microbe permeability of sterilized packs. Comparison of the bubble pressure method, testing of microbe permeability according to DIN 58953 part 6 and the particle count test].
Three different methods (the germ impermeability test according to the guidelines of DIN 58953 part 6, paragraph 2.15 (3), bubble-point method according to CEN EN AA 002 Annex C (1), and particle-penetration test (2)) were tested for their suitability to prove the microporosity and germ impermeability of sterilization packs. The results of the bubble-point method and the particle-penetration test differed from each other to a certain extent. The results of the germ impermeability test according to DIN do not agree with those of the other methods. The DIN method has the advantage of giving practice orientated conditions. Therefore we recommend for the germ impermeability test of sterilization packs the method according to the guidelines of the DIN.
Robert Koch-Institut des Bundesgesundheitsamtes, Berlin.
A
A
Hummel
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P
Wagner
J
J
Peters
D010539:Permeability; D016062:Porosity; D011786:Quality Control; D015203:Reproducibility of Results; D013242:Sterilization / Q000592:standards*