ISO 11137 relates to methods of sterilisation of health products
The ISO 11137 standard specifies the methods for microbiological control of irradiation sterilisation processes for medical devices and to determine the sterilising dose. Ultra-clean providers must therefore implement manufacturing procedures that comply with this standard to guarantee the safety and reliability of their products.
As a leader in ultra-clean in France, we work with manufacturers recognised for the conformity of their products with the quality and safety standards in force. In fact, the products we offer have been validated according to the requirements of the ISO 11137 standard. They have been subjected to extensive controls including microbiological monitoring and an audit of the sterilisation dose.
For this purpose, the sterile consumables listed in our catalogue have a level of sterility assurance in compliance with the different parts of this standard (ISO 11137-1, 2, 3).
Services related to the sterilisation of health products
Our field of activity is not limited to the distribution of biological and particulate decontamination solutions. In order to best support our customers, we provide services in various fields, including bacteriological, physicochemical and particulate control of equipment. Their packaging is also one of our specialities, thanks to our ISO5 clean room.
Thanks to the technical skills of our team of experts, we guarantee quality services that meet the requirements of your business. Our professionalism and responsiveness have earned us the confidence of the majority of ultra-clean companies.
