DS/EN ISO 8871-3-2005

Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count


 

 

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标准号
DS/EN ISO 8871-3-2005
发布日期
2005年03月29日
实施日期
2005年03月29日
废止日期
国际标准分类号
11.040.20
发布单位
丹麦标准化协会
被代替标准
DS/EN ISO 8871-1997
适用范围
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.

DS/EN ISO 8871-3-2005系列标准





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