Sterilization by Steam

Steam sterilization of medical devices

This course - Validation of Sterilization by Steam according to EN ISO 17665-1 - is designed to provide participants with an understanding of the requirements for sterile medical devices and compliance with MDR.

This 1 day training course provides an in depth knowledge of the EN ISO 17665-1 to -3 requirements and the accompanying study cases.  Medical Device Software & Sterilization Professionals provide this course worldwide from our base in Lee-on-the-Solent, Hampshire.

Learning objectives / course outcomes

On completion of this training, participants will be able to:

  • Identify the links between MDR and EN ISO 17665-1, -2, -3
  • Define the requirements for the validation of sterilization
  • Define the type of indicator used and its compliance with ISO 11138-1 and -3
  • Define the requirements for the sterilization in routine and the release of batches
  • Identify the content of a validation report of sterilisation

Intended audience

  • Regulatory, quality assurance managers and personnel
  • Design and development managers and personnel
  • Quality control personnel

Content of the course

  • I- Introduction
  • II- Characterisation of the device’s material
  • III- What type of indicator to use
  • IV- Validation- IQ
  • V- Validation- OQ
  • VI- Validation- PQ
  • VII- Requalification- maintenance
  • VIII- Controls in routine
  • IX- Impact of the medical device’s modification on sterilization process and extension of range
  • X- Bioburden and sterility testing

Prerequisites

MDSSPRO use interactive learning techniques so as to keep the course varied.  We also account for applications and study cases. Our tutors are among the leading educators in the region and will make sure your learning needs are met. Choose between online or in-company courses, either can be tailored to your business needs.

Price

The course is £450 per person. We also offer this training at a special price for students, for more details contact us at admin@mdsspro.com. 

On site training can be tailored to your needs. For more details, contact admin@mdsspro.com.
If you have any queries about our Sterilization by Steam course, please email
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