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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2. Principle of supercritical CO2 cleaning

2.1 Definition of the supercritical range

Like any pure body, CO ₂ can be found in three different states of matter: the liquid, solid or gaseous state, depending on the thermodynamic parameters of pressure P, temperature T and volume V and quantity of matter n (mole). These parameters, known as variables of state, are not independent and are linked by an equation of state. A simple expression of this equation of state is the well-known perfect gas equation.

In figure 2 is given the phase diagram P = f (T ) of CO ₂ . The lines represented on this diagram correspond, at a given pressure,...

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Ongoing reading
Principle of supercritical CO2 cleaning

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page Regulatory issues related to medical devices

Implementation of the cleaning process

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...