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International standard (ISO) of radiation sterilization and issues in the sterilization dose setting

Masaaki Takehisa

Radiation Physics and Chemistry 46(4-6-Part-P2): 1349-1352

1995

ISSN/ISBN: 0969-806X
DOI: 10.1016/0969-806x(95)00384-a
Document Number: 430326
The Iso dose setting method 1 uses bioburden and verification by sublethal sterility test. Current devices produced in clean environment have low bioburden, however, sensitivity of verification test declines at low bioburden. Validation of verification in this region should be further studied. A dose setting using D10 of bioburden isolates should be reevaluated and included in the ISO.

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