ISO 11135 specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both industrial and healthcare facility settings and recognizes the similarities and differences between the two applications.
ISO is a worldwide federation of national standards bodies (ISO member bodies). The work of drafting International Standards is normally carried out through ISO technical committees. Any member body dealing with a subject for which the technical committee has been established has the right to be represented on that committee. International organizations, government and non-governmental organizations in contact with ISO also take part in the studies. ISO works closely with the International Electrotechnical Commission (IEC) on all matters related to electrotechnical standardization.
Attention is drawn to the possibility that some elements of this standard may be the subject of patent rights. ISO cannot be held responsible for the determination of any or all such patent rights.
EUROLAB assists manufacturers with ISO 11135 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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