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

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

DIN EN ISO 8871-3-2004 发布历史

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.

DIN EN ISO 8871-3-2004由德国标准化学会 DE-DIN 发布于 2004-09。

DIN EN ISO 8871-3-2004 在中国标准分类中归属于: C92 制药加工机械与设备，在国际标准分类中归属于: 11.040.20 输血、输液和注射设备。

DIN EN ISO 8871-3-2004的历代版本如下：

• 2004年09月 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

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标准号

DIN EN ISO 8871-3-2004

发布日期

2004年09月

实施日期

废止日期

无

中国标准分类号

C92

国际标准分类号

11.040.20

发布单位

DE-DIN

被代替标准

DIN EN ISO 8871-3-2003 DIN ISO 8871/A1-1996

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.

DIN EN ISO 8871-3-2004系列标准

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