Regulatory issues related to medical devices
Dry cleaning of medical devices by supercritical CO2

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MED7700 V1 Article

Regulatory issues related to medical devices
Dry cleaning of medical devices by supercritical CO2

Authors : Stéphane BREDEAU, Julie CHAPELAIN

Review date: September 1, 2023 | Lire en français

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1. Regulatory issues related to medical devices

1.1 Medical devices

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1.1.1 Definition

Medical devices are defined by ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) as instruments, apparatus, equipment or software intended by their manufacturer to be used in humans for the diagnosis, prevention, control, treatment or alleviation of disease or injury.

They range from thermometers, defibrillators and dressings to injectable products (e.g. hyaluronic acid for joints) and implantable products (e.g....

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