This standard defines the procedures that allow the identification and classification of elastomeric elements that constitute primary packaging and medical devices used in direct contact with aqueous preparations for parenteral use, including preparations in dry form that must be dissolved before use. . This standard specifies a series of comparative test methods for chemical and biological evaluation (see chapter 6) and describes various fields of application of elastomeric elements. The dimensions and functional characteristics are specified in the relevant International Standards. The required properties specified in this standard should be considered minimum requirements. 2 This standard applies to the categories of elastomeric elements given in chapter 3; however, specific requirements are set out in the relevant International Standards dealing with the aspects or products listed in Chapter 3. NOTE – Elastomeric elements are excluded, by definition, for empty single-use syringes (see ISO 7886 Standard). 3 The parenteral preparations to be tested must undergo compatibility studies before approving these elements for final use. This standard does not specify, however, the procedures that must be followed to study compatibility.
UNE-EN 28871:1994 history
1994UNE-EN 28871:1994 Elastomeric parts for aqueous parenteral preparations (ISO 8871: 1990)