DIN EN ISO 8871-3-2004 非肠道及制药设备用弹性件.第3部分:释放粒子计数的测定

标准号：DIN EN ISO 8871-3-2004
中文标准名称：非肠道及制药设备用弹性件.第3部分:释放粒子计数的测定
英文标准名称：Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 3: Determination of released-particle count (ISO 8871-3:2003); German version EN ISO 8871-3:2004, text german and english
标准类型：C92
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：C92
国际标准分类号：11.040.20
适用范围：Elastomeric parts may be superficially contaminated with particles visible to the naked eye. Such particles may be transferred to pharmaceutical preparations in contact with the elastomeric parts, and detoriate the quality of such preparations. The method serves to evaluate contamination of this kind by collecting and counting the particles, detached from the elastomeric part by rinsing.