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If you are managing sterile medical devices ensure that biocompatibility studies to EN10993 have been undertaken.

Many medical devices and specifically those that come into contact with a patient’s body are subject to biological and biocompatibility testing. This testing is to assess the interaction between body fluids, tissue or cells with the device in order to protect the patient from potential risk. Risk includes toxicity and irritations – tests are dependent on how long the device is in direct contact with a patient, the type of device as well as what it is made from.

If you are in any doubt about your device and the EN10993 directive Atlantic Bridge can help you work through the necessary processes and procedures.