标准摘要
[中文适用范围]: 本部分规定了血液采集器的类型要求,以确保输血设备的功能互换性。它适用于单次使用的灭菌血液采集器。本部分还旨在提供以下内容:a) 关于输血设备所用材料的质量和性能的要求;b) 输血设备术语的统一表示。在某些国家,国家药典或其他国家级法规具有法律效力并优先于本部分。 [外文原描述]: 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.
英文名称Transfusion equipment for medical use — Part 3: Blood-taking sets for single use