BS EN ISO 8536-11:2015适用于一次性使用的消毒输液过滤器，使用压力不超过200 kPa（2 bar） ISO 8536-8中规定的压力输液设备和输液器的流体管路。它不包括 用于分离颗粒或细菌的过滤器的有效性。在一些国家，国家药典或其他国家法规具有法律约束力，且 优先于ISO 8536的本部分。交叉引用:ISO 594-2ISO 7000ISO 8536-8ISO 10993-4ISO 15223-1EN ISO 8536-8:2015EN ISO 10993-4:2009EN ISO 15223-1:201293/42/EECISO 8536-8ISO 11135ISO 11137-1ISO 11137-2ISO 17665-1EN 15986购买本文件时提供的所有当前修订版均包括在内。

BS EN ISO 8536-11:2015 applies to sterilized infusion filters for single use used up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536-8. It does not include the effectiveness of filters for separation of particles or germs.In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over this part of ISO 8536.Cross References:ISO 594-2ISO 7000ISO 8536-8ISO 10993-4ISO 15223-1EN ISO 8536-8:2015EN ISO 10993-4:2009EN ISO 15223-1:201293/42/EECISO 8536-8ISO 11135ISO 11137-1ISO 11137-2ISO 17665-1EN 15986All current amendments available at time of purchase are included with the purchase of this document.