非肠道和制药设备用弹性件.第1部分:含水autoclavates中的萃取物

[中文适用范围]： ISO 8871 的这一部分定义了与注射用制剂直接接触的初级包装和医疗器械的弹性体部件的分类程序，包括水性制剂和在使用前必须溶解的干制剂。 它规定了一系列通过测定水性高压灭菌器中的可萃取物进行化学评估的比较测试方法（参见第 4 条），并描述了弹性体部件的各个应用领域。 相关国际标准中规定了尺寸和功能特性。 ISO 8871 本部分中指定的所需属性被视为最低要求。 2 ISO 8871的本部分适用于第3章给出的弹性体零件类别；然而，涉及第 3 条中列出的物品或设备的相关国际标准中规定了具体要求。 一次性使用空注射器的弹性部件不属于 ISO 8871 本部分的范围，因为它们不与注射制剂相当长的时间。 3 在批准最终使用之前，必须进行与预期制剂的相容性研究；然而，ISO 8871 的这一部分没有规定进行兼容性研究的程序。 [外文原描述]： ISO 8871-1:2003 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 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. 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. 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.