1. Regulatory issues related to medical devices
1.1 Medical devices
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
Bibliography
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...
Patents
Method, device and installation for cleaning contaminated parts, with a dense pressurized fluid WO2002032593A1
Dense fluid treatment process and apparatus with landfill storage volume EP3148717B1
Process and apparatus for supercritical fluid treatment with additive injection CA2949891A1
Process and apparatus for supercritical fluid treatment with passive...
Directory
Manufacturers – Suppliers – Distributors (non-exhaustive list)
DFD SA (Dense Fluid Degreasing) https://www.dfd-co2.com/fr/http://neel.cnrs.fr/spip.php?article1324
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