Ελαστομερή στοιχεία για παρεντερική χορήγηση και για διατάξεις για φαρμακευτική χρήση - Μέρος 2: Ταυτοποίηση και χαρακτηρισμός

This document specifies identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices. The physical and chemical test procedures specified in this document permit the determination of the typical characteristics of elastomeric parts including coatings and surface treatments and can serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. Depending upon the type of elastomer and its application, an appropriate set of tests is selected.