
T/CAMDI 023-2019
去白细胞滤器用聚酯过滤膜
Polyester fiItration membrane for Leukocyte reduction fiIters
2019-01-01 发布
2019-07-01 实施
前言..............................................1
1范围...........................................1
2规范性引用文件 .................................1
3分类与标记...............................................2
4材料...........................................2
5物理要求..............................................2
5.1外观..................................................2
5.2分层..............................2
5.3单位面积质最.................................2
5.4厚度..............................2
5.5最大孔径..............................2
6.化学要求……..........................2
6.1溶出物..........................................3
6.2荧光物.......................................
7生物要求........................................3
7.1 总则.........................................3
7.2微生物限度......................................3
8标志...........................................3
8.1初包装........................................3
8.2外包装........................................3
附录A (规范性附录)物理试验..............9
附录B (规范性附录)化学性能检验液的制备......................10
附录C (规范性附录)生物试验.............................................11
附录D (资料性附衆)设计与实施的指南..............................13