Transfusion equipment for medical use-Blood-taking sets for single use
医用输液设备
发布日期:
2017-02-28
BS EN ISO 1135-3:2017规定了医疗用采血器类型的要求
确保输液设备的功能互换性。适用于无菌采血
仅限一次性使用。ISO 1135的这一部分还旨在提供与输血用材料的质量和性能有关的规范
设备,以及此类设备术语的统一表述。
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 1135的本部分。交叉引用:EN ISO 3696:1995ISO 3696:1987EN ISO 7864:2016EN ISO 11607-1:2009+A1:2014ISO 11607-1:2006ISO 11607-1:2006/A1:2014EN ISO 14644-1:2015ISO 14644-1:2015EN ISO 15223-1:2012ISO 15223-1:201293/42/EECISO 291ISO 594-1:1986ISO 594-2:1998ISO 1773:1997ISO 3826-2ISO 7000ISO 8536-14966ISO 1096ISO 1096ISO 1165ISO 11637-1114EC购买本文件时提供的最新修订包括在购买本文件中。
BS EN ISO 1135-3:2017 specifies requirements for types of blood-taking sets for medical use in order
to ensure functional interchangeability of transfusion equipment. It is applicable to sterilized bloodtaking
sets intended for single use only.This part of ISO 1135 also aims to providespecifications relating to the quality and performance of materials used in transfusion
equipment, anda unified presentation of terms for such equipment.
In some countries, the national pharmacopoeia or other national regulations are legally binding and
take precedence over this part of ISO 1135.Cross References:EN ISO 3696:1995ISO 3696:1987EN ISO 7864:2016ISO 7864:2016EN ISO 11607-1:2009+A1:2014ISO 11607-1:2006ISO 11607-1:2006/A1:2014EN ISO 14644-1:2015ISO 14644-1:2015EN ISO 15223-1:2012ISO 15223-1:201293/42/EECISO 291ISO 594-1:1986ISO 594-2:1998ISO 1773:1997ISO 3826-2ISO 7000ISO 8536-14ISO 9626ISO 10993-1ISO 10993-4ISO 11135ISO 11137ISO 17665-1IEC 80416-1DIN 13097-4DIN 13097-5All current amendments available at time of purchase are included with the purchase of this document.