5. Conclusion

The cleaning of medical fabrics and mechanical parts, whether implantable or not, consists in removing all dirt and contamination (cutting and sizing oils, solid particles, dust, etc.) from their surface. The aim of this step is to render the surface physically clean, to enable subsequent operations in the production process to run smoothly, and to guarantee the quality and reliability of the finished product.

Taking these considerations into account, the special properties of supercritical fluids make cleaning with CO ₂ SC a relevant alternative technique for removing lubricants (cutting and sizing oils) and particles compared with conventional cleaning methods in leach or with conventional solvents (modified alcohol, hydrocarbon). In fact, CO ₂ SC technology enables a wide...

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Conclusion

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page Examples of applications on medical devices

Glossary

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...