steam sterilization EN ISO 17665-1 (steam201909)


Description
This course is designed to provide participants with understanding of the EN ISO 17665-1 requirements for sterile medical devices and compliance with MDR and MDD.
This 1 day training provides an in depth knowledge of the EN ISO 17665-1 requirements and study cases.
Content
  • Module 1- Introduction
  • introduction
  • Module 2- characterisation of material
  • characterisation of materials
  • Module 3- Bioindicators
  • example1 of BI's IFU
  • example2 of BI's IFU
  • incubation of rapid BIs
  • BIs
  • Module 4- Validation IQ
  • validation IQ
  • module 5- validation OQ
  • validation OQ
  • module 6- validation PQ
  • PQ test
  • module 7- Requalification
  • Requalification test
  • protocol validation example 1
  • validation protocol
  • validation report example 2
  • example 1 of validation report
  • Validation report analysis
  • Module 8- controls in routine
  • controls in routine
  • Module 9- impact of modifications
  • impact of modifications
  • module 10- Bioburden
  • Bioburden test
Completion rules
  • All units must be completed
  • Leads to a certificate with a duration: Forever