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The objective of this training is to familiarise delegates with the requirements of ISO 11137 for control of radiation sterilisation (in particular gamma radiation sterilisation) to allow manufacturers of medical devices to ensure continued regulatory compliance.

Sterilisation by irradiation is based on ISO 11137-1:2015 Sterilisation of Health Care Products (Radiation - Part 1) focused on the requirements for development, validation and routine control of a sterilisation process for medical devices, and on ISO 11137-2:2015 Sterilisation of Health Care Products (Radiation - Part 2), focused on establishing the sterilisation dose.

At the end of this training, delegates will be able to:

  • Meet regulatory requirements, such as 93/42/EEC Essential Requirements and 2017/745 MDR General Safety & Performance Requirements, which require the use of a validated sterilization process
  • Have an awareness of microbiological requirements, including controlling bioburden before sterilisation, and ISO 11371-1-2 test methods for bioburden and sterility testing in process validation
  • Appreciate different types of radiation sterilisation process - Gamma, Electron Beam, X-ray and understand the basic aspects of Gamma Radiation Sterilisation
  • Be familiar with the major features of ISO 11137 (Parts One-Three):
    • Learn about product families and processing categories so that different devices can be grouped together
    • Understand the requirements for establishing the radiation dose
    • Be familiar with the major features of a Gamma Radiation Validation report
    • Identify the requirements for continued control including dose audits and re-qualification
    • Understand the guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017)
  • Understand the ways of monitoring and controlling outsourced sterilisation
  • Be aware of what your Notified Body will expect to check and audit

SGS offers practical and up to date interactive training in the area of sterilisation in-house, at your company premises.

Contact SGS now for further information on SGS ISO 11137-1-2-3 Sterilisation of Health Care Products – Radiation.