標準號：BS EN ISO 8871-2-2004
中文標準名稱：非腸道及制藥設備用彈性件.識別和特性
英文標準名稱：Elastomeric parts for parenterals and for devices for pharmaceutical use - Identification and characterization
標準類型：C92
發布日期：2004/9/8 12:00:00
實施日期：2004/9/8 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：This part of ISO 8871 specifies evaluation procedures applicable to elastomeric parts used for drug containers and medical devices in order to guarantee the product identity between the samples evaluated in the (suitability test) acceptance process and the current supplies. The physical and chemical test procedures specified in this part of ISO 8871 permit the determination of the typical characteristics of rubber materials, and may serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. An appropriate set of tests is selected, depending upon the type of rubber and its application. This part of ISO 8871 does not specify other requirements for rubber materials. These are laid down in the relevant product standards.