Transfusion equipment for medical use — Part 3: Blood-taking sets for single use
输血设备用于医疗用途 - 第3部分:单次使用采血套件
发布日期:
2016-10-21
ISO 1135-3:2016规定了医用采血器类型的要求,以确保输血设备的功能互换性。适用于一次性使用的无菌采血器。
ISO 1135-3:2016还旨在提供
a) 与输血设备所用材料的质量和性能有关的规范,以及
b) 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,优先于ISO 1135-3:2016。
ISO 1135-3:2016 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 blood-taking sets intended for single use only.
ISO 1135-3:2016 also aims to provide
a) specifications relating to the quality and performance of materials used in transfusion equipment, and
b) a unified presentation of terms for such equipment.
In some countries, the national pharmacopoeia or other national regulations are legally binding and take precedence over ISO 1135-3:2016.