ISO 8871-1-2003 非肠道和制药设备用弹性件.第1部分:含水autoclavates中的萃取物

标准号：ISO 8871-1-2003
中文标准名称：非肠道和制药设备用弹性件.第1部分:含水autoclavates中的萃取物
英文标准名称：Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates
标准类型：C36
发布日期：1999/12/31 12:00:00
实施日期：1999/12/31 12:00:00
中国标准分类号：C36
国际标准分类号：11.040.20
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.