Validation of sterilisation by irradiation according to EN ISO 11137
This course is designed to provide participants with understanding of the EN ISO 11137 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 sterilisation
Define the type of dosimeters used and its compliance with ISO ASTM 52628
Define the requirements for the sterilisation in routine and the release of batches
Identify the content of a validation report of sterilisation
Regulatory, quality assurance managers and personnel
Design and development managers and personnel
Quality control personnel
Content of the course
II- Characterisation of the device’s material and interaction with the irradiation
II- What type of dosimeter to use
V- Validation- OQ
VI- Validation- PQ
VII- Requalification- maintenance
VIII- Controls in routine
IX- Impact of the medical device’s modification on sterilisation 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
On site training is tailored by on your needs. For more details contact