| Titre : |
The VDI guideline "medical grade plastics" : Clarity and mandatory procedures for plastics in medical products |
| Type de document : |
texte imprimé |
| Auteurs : |
Thomas Seul, Auteur ; Stefan Roth, Auteur |
| Année de publication : |
2018 |
| Article en page(s) : |
p. 37-39 |
| Langues : |
Anglais (eng) |
| Catégories : |
Certification
Formulation (Génie chimique)
Gestion de l'approvisionnement
Matériel médical
Matières plastiques -- Normalisation
Polymères en médecine
Relations clients-fournisseurs
|
| Index. décimale : |
668.4 Plastiques, vinyles |
| Résumé : |
Selecting the right material is already a challenging procedure for developers, and is even more difficult for medical products: in addition, critical quality attributes are needed that make it necessary to perform, for example, a biological assessment. |
| Note de contenu : |
- What ISO10993 means
- Who bears the responsibility for medical products?
- Origin and development of the VDI guideline
- The lowest common denominator for medical grade plastics
- Summary : a guideline as a code of practice
- FIGURES : 1. Formulation consistency is an important requirement for constant properties - 2. Supply security : measures intended to ensure security of supply - 3. Change management responds to changes in the constancy forumlation (composition, components), manufacturing process, security of supply and in the event of conformity declarations). By passing on information to the customer, the supplier ensures that the information flow takes place from manfuacturer to distributor - 4. Content of the necessary quality agreement : In the customer-supplier relationship, the quality agreement plays a central role and is fixed between the two partners |
| En ligne : |
https://drive.google.com/file/d/1sGzbn-YiQWMPKE_J6IfDc1vIGmhk3PyB/view?usp=drive [...] |
| Format de la ressource électronique : |
Pdf |
| Permalink : |
https://e-campus.itech.fr/pmb/opac_css/index.php?lvl=notice_display&id=30490 |
in KUNSTSTOFFE INTERNATIONAL > Vol. 108, N° 4 (04/2018) . - p. 37-39
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The VDI guideline "medical grade plastics" in KUNSTSTOFFE INTERNATIONAL, Vol. 108, N° 4 (04/2018)
