ISO 8871-1:2003定义了与非肠道用制剂直接接触的主要包装和医疗器械用弹性体零件的分类程序，包括使用前必须溶解的水性制剂和干制剂。 本标准规定了一系列通过测定水性高压釜中可萃取物进行化学评估的比较试验方法，并描述了弹性体零件的各种应用领域。相关国际标准中规定了尺寸和功能特性。ISO 8871本部分规定的所需性能被视为最低要求。 一次性使用的空注射器的弹性部件不在ISO 8871本部分的范围内，因为它们在相当长的时间内不与注射制剂接触。 在批准最终使用前，必须进行与预期制剂的相容性研究；然而，ISO 8871的本部分并未规定进行兼容性研究的程序。

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.