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.ISO 11137-3:2017 gives guidance on
meeting the requirements in ISO 11137-1 and ISO 11137-2 and in ISO/TS 13004
relating to dosimetry and its use in development, validation and routine
control of a radiation sterilization process. 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.
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.
The ANSI/AAMI/ISO 11137 - Sterilization of Health Care
Products Package provides the requirements for developing, validating and
routinely controlling the sterilization process of medical devices. In addition
to providing the requirements for the sterilization process of medical devices,
this package also considers the products' environment, personnel and their
hygiene, packaging / storage, sterilization doses and more to inactivate
microbiological contaminants on medical devices.
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