Medical Device Standards Order (Endotoxin Requirements for Medical Devices) 2018

The Medical Device Standards Order (Endotoxin Requirements for Medical Devices) 2018 establishes the endotoxin limits for medical devices to minimize risks associated with endotoxin contaminants and residues. 

These limits are crucial for ensuring the safety and efficacy of medical devices, particularly those that come into direct or indirect contact with a person's cardiovascular system, lymphatic system, or cerebrospinal fluid, and are labelled as sterile and non-pyrogenic. 

The order specifies that the cumulative endotoxin content of each individual component must not exceed the overall threshold limit for the final product, as set out in the order. 

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