Dose mapping for documentation of radiation sterilization |
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Authors: | Arne Miller |
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Institution: | Risø High Dose Reference Laboratory, Bldg 313, Risø National Laboratory, DK 4000 Roskilde, Denmark |
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Abstract: | The radiation sterilization standards EN 552 and ISO 11137 require that dose mapping in real or simulated product be carried in connection with the process qualification. This paper reviews the recommendations given in the standards and discusses the difficulties and limitations of practical dose mapping. The paper further gives recommendations for effective dose mapping including traceable dosimetry, documented procedures for placement of dosimeters, and evaluation of measurement uncertainties. |
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