Validation of sterilization by irradiation according to EN ISO 11137-1 & -2

Course Description

This course is designed to provide participants with understanding of the EN ISO 11137-1 & -2 requirements for sterile medical devices and compliance with MDR and MDD.

This 1 day training provides an in depth knowledge of the EN ISO 1137-1 to -3 requirements and study cases.




Learning objectives / course outcomes

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

  • Identify the links between MDD/ MDR and EN ISO 11137-1, -2, -3

  • Define the requirements for the validation of sterilization

  • Define the type of dosimeters used and its compliance with ISO ASTM 52628

  • Define the requirements for the sterilization in routine and the release of batches

  • Identify the content of a validation report of sterilization


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 and interaction with the irradiation

II- What type of dosimeter 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 et sterility testing


Participants should have basic knowledge of microbiology and packaging requirements.


How will I learn?

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. Choose between online or in-company courses tailored to your business.



 We are providing online training course for £450 per person. We also offer this training at a special price for student, for more details contact us at 


On site training is tailored by on your needs. For more details contact

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