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ISO 11137-1-2 – Sterilization of Health Care Products – Radiation

The objective of this training is to familiarize delegates with the requirements of ISO 11137 for control of radiation sterilization (in particular gamma radiation sterilization) 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.

Sterilization by irradiation is based on ISO 11137-1:2006 Sterilization of Health Care Products (Radiation - Part 1) focused on the requirements for development, validation and routine control of a sterilization process for medical devices. It is also based on ISO 11137-2:2006 Sterilization of Health Care Products (Radiation - Part 2) focused on establishing the sterilization 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 sterilization process
  • Have an awareness of microbiological requirements, including controlling bioburden before sterilization, and ISO 11731-1-2 test methods for bioburden and sterility testing in process validation
  • Appreciate different types of radiation sterilization process - Gamma, Electron Beam, X-ray and understand the basic aspects of Gamma Radiation Sterilization
  • 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 sterilization
  • 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 sterilization 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 Sterilization of Health Care Products – Radiation.

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