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The standard defines and describes, what is to be understood by the term 'medical-grade plastics' and what qualities and demands are decisive for plastics to be used them for medicine products. It helps raw material producers and manufacturers of plastic products of medicine products to contribute to a constant recipe, quality, biocompatibility and security of delivery. In standardisation to date, no detailed definition exists for the term 'medical-grade' and the demands for corresponding plastics for medical products are also not defined. The standard defines the demands for plastics for the application in medical products and compiles a standard to be used as a guideline by raw material producers and manufacturers of medical products. The areas of development, logistics, procurement and purchase are equally grasped by this standard.
Author | VDI |
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Editor | VDI |
Document type | Standard |
Format | File |
expiration_de_validite | 2018-09-30 |
ICS | 11.100.20 : Biological evaluation of medical devices
83.080.01 : Plastics in general |
Number of pages | 20 |
Year | 2018 |
Document history | |
Country | Germany |
Keyword | 2017 |