標準號：BS EN ISO 8871-3-2004
中文標準名稱：非腸道及制藥設備用彈性件.釋放粒子計數的測定
英文標準名稱：Elastomeric parts for parenterals and for devices for pharmaceuticals use - Determination of released-particle count
標準類型：C92
發布日期：2004/6/9 12:00:00
實施日期：2004/6/9 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 closures may be superficially contaminated with visible and subvisible particles, and fragments can also be produced when the closure is pierced by a needle. Such particles may be transferred to pharmaceutical preparations in contact with the elastomeric parts and affect the quality of such preparations. This part of ISO 8871 specifies methods for the determination of the number of visible and subvisible particles, respectively, detached from elastomeric parts by rinsing. It does not specify particle contamination limits. These will have to be agreed upon between manufacturer and user.