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Breathing gas Pathways Regulations

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Breathing Gas Pathways

In order to market a medical device in the EU, a CE Mark certificate is needed. This certificate verifies that the product is safe and performs as intended. The ISO 18562-1 standard prescribes a process for testing and documenting the biological safety of the gas pathway of a medical device product intended to provide respiratory care or supply substances via the respiratory tract. SAXOCON can help get your products ready for approval.

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