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EO sterilization: Compliance to ISO 11135 (ST0101)


Description
This course is designed to provide participants with understanding of the EN ISO 11135 requirements for sterile medical devices and compliance with MDR and MDD.
This 12h training provides an in depth knowledge of the EN ISO 11135 requirements and study cases.
We use interactive learning techniques, keeping the course varied and with applications and study case.
Our tutors are the best and will make sure your learning needs are met.
The pass mark of the test is 70%, if you don't reach this minimum you will be asked to redo the test.
Content
  • module 1- introduction
  • introduction
  • module 2- characterization of materials
  • characterisation of materials
  • Module 3- Bio-indicators
  • example of BI IFU
  • example 2 BI IFU
  • BIs
  • Module 4- Validation IQ
  • example sterilizer user's manual
  • Example sterilizer user's manual
  • validation IQ
  • Module 5-validation OQ
  • validation OQ
  • module 6- validation PQ
  • PQ test
  • example of validation protocol
  • validation protocol
  • module 7- Requalification
  • Requalification test
  • example of validation report
  • Validation report analysis
  • module 8- EO residual
  • EO residual test
  • module 9- Bioburden
  • Bioburden test
  • customer feedback
Completion rules
  • All units must be completed
  • Leads to a certificate with a duration: Forever
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