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Sterilization by irradiation - EN ISO 11137-1


Description
This course is designed to provide participants with understanding of the EN ISO 11137-1 requirements for sterile medical devices and compliance with MDR and MDD.
This 1 day training provides an in depth knowledge of the EN ISO 11137-1 requirements and study cases.
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Content
  • Introduction
  • introduction test
  • material characterisation
  • Material characterisation test
  • Dosimeters
  • Dosimeter test
  • alanine dosimeter information sheet
  • Alanine dosimeter calibration
  • Gafchromic dosimeter brochure
  • IQ,OQ validation
  • IQ,OQ test
  • PQ Validation
  • PQ validation
  • Example of validation report according to EN ISO 11137-2
  • calculation of the dose
  • Monitoring and modifications
  • monitoring and modification
  • Example of dose audit
  • analysis of a report
  • Bioburden
  • Bioburden test
  • Survey
Completion rules
  • All units must be completed
  • Leads to a certificate with a duration: Forever
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