Article | REF: MED7700 V1

Dry cleaning of medical devices by supercritical CO2

Authors: Stéphane BREDEAU, Julie CHAPELAIN

Publication date: November 10, 2018, 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...

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Regulatory issues related to medical devices

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Principle of supercritical CO2 cleaning

Bibliography

(1) - SARRADE (S.), BENAISSI (K.) - Le CO ₂ supercritique et ses applications industrielles. - L'actualité chimique, 371-372, p. 72 (2013).
(2) - BENAISSI (K.) - Les fluides supercritiques à votre service....

Websites

NIST (National Institute of Standards and Technology), Pure Bodies Database https://webbook.nist.gov/chemistry/fluid/ (page consulted on June 3, 2018)

Femto-physique website https://femto-physique.fr/physique_statistique/diffusion-moleculaire.php...

Events

Trade fair: Parts2Clean International cleaning trade fair, held every year in Stuttgart http://www.parts2clean.de/home

Standards and norms

Salles propres et environnements maîtrisés apparentés : Partie 1 : Classification de la propreté particulaire de l'air - NF EN ISO 14644-1 - 2015
Medical devices – Quality management systems. Requirements for regulatory purposes - ISO 13485 - 2016
Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity - ISO 10993-5 - 2009
Surgical implants. Artificial ligaments. Part...

Regulations

European Directive 90/385/EEC of June 20, 1990 on the approximation of the laws of the Member States relating to active implantable medical devices.

European Directive 93/42/EEC of June 14, 1993 concerning medical devices.

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 concerning medical devices, amending Directive 2001/83/EC, Regulation...