標準號：DIN EN ISO 8871-3-2004
中文標準名稱：非腸道及制藥設備用彈性件.第3部分:釋放粒子計數的測定
英文標準名稱：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
標準類型：C92
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C92
國際標準分類號：11.040.20
適用范圍：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.