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BS EN ISO 8871-1-2004
Elastomere Teile zur Parenteralia und fuer Produkte zur pharmazeutischen Verwendung. Extrahierbare Substanzen in waessrigen Autoklavaten Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1:Extractables in aqueous autoclavates Elements en elastomere pour administration parenterale et dispositifs a usage pharmaceutique. Substances extractibles par autoclavage en milieu aqueux Together with BS EN ISO 8871-2 and-3,Partially supersedes BS EN ISO 8871:1997
适用范围：1 This part of ISO 8871 defines procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including both aqueous preparations and dry preparations which have to be dissolved before use. It specifies a series of comparative test methods for chemical evaluation by the determination of extractables in aqueous autoclavates (see Clause 4) and describes the various fields of application for elastomeric parts. Dimensions and functional characteristics are specified in the relevant International Standards. Required properties as specified in this part of ISO 8871 are regarded as minimum requirements. 2 This part of ISO 8871 is applicable for the categories of elastomeric parts given in Clause 3; specific requirements, however, are laid down in the relevant International Standards dealing with the items or devices listed in Clause 3. Elastomeric parts for empty syringes for single use are excluded from the scope of this part of ISO 8871 as they are not in contact with the injected preparation for a significant length of time. 3 Compatibility studies with the intended preparation have to be performed before the approval for final use can be given; however, this part of ISO 8871 does not specify procedures for carrying out compatibility studies.
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