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ISO 11137-1-2 - Sterilisation of Health Care Products - Radiation

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. The ISO 11137 standard is of particular importance due to the irradiation standard ISO 11137 requirements in the latest version being effectively mandatory in Europe since April 2009.

Sterilisation by irradiation is based on ISO 11137-1:2006 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. It is also based on ISO 11137-2:2006 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 the essential regulatory requirements, such as 93/42/EEC which requires the use of a validated sterilisation process
  • Have an awareness of microbiological requirements, including controlling bioburden before sterilisation, and ISO 11731-1-2 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 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 training in the area of sterilisation as public training or tailored in-house training. We can help with initial certification, regulatory approval, and also checks on compliance by performing an SGS gap analysis audit.

All training provided by SGS experts is in English, and when applicable your local language.

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

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