4. Examples of applications on medical devices

4.1 Desensitization of implantable tissues

CO ₂ SC technology is particularly interesting for medical devices, as it enables residue-free cleaning in cleanrooms and greatly reduces bioburden (by 2 to 3 log), a level of quality still unrivalled on the market. Its low-temperature operation (between 35 and 50°C) preserves polymers and therefore does not lead to changes in their mechanical properties. A single CO ₂ treatment sometimes replaces several successive washing operations, and can cut cleaning time by up to 10 (2 to 3 h vs. 24 h for a diethyl ether Soxhlet process). On implantable textiles (knitted, woven), tests carried out on various polymers (PP, PLLA, PET, PE) validated the removal...

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Examples of applications on medical devices

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Conclusion

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...