ISO 3826-1:2019 人体血液和血液成分用可折叠塑料容器 第1部分：常规容器

标准编号：ISO 3826-1:2019

中文名称：人体血液和血液成分用可折叠塑料容器 第1部分：常规容器

英文名称：Plastics collapsible containers for human blood and blood components — Part 1: Conventional containers

发布日期：2019-09

标准范围

本文件规定了用于血液和血液成分收集、储存、加工、运输、分离和管理的塑料可折叠、非通风、无菌容器（称为塑料容器）的要求，包括性能要求，该容器配有收集管出口、整体针和可选传输管。塑料容器可以包含抗凝剂和/或防腐剂溶液，具体取决于设想的应用。本文件也适用于塑料容器的多个单元，例如双单元、三单元、四单元或多个单元。除非另有规定，本文件中规定的所有试验均适用于准备好使用的塑料容器。本文件不适用于带有集成过滤器的塑料容器。

This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers (known as plastics containers) complete with collecting tube outlet port(s), integral needle, and with optional transfer tube(s), for the collection, storage, processing, transport, separation, and administration of blood and blood components. The plastics containers can contain anticoagulant and/or preservative solutions, depending on the application envisaged.This document is also applicable to multiple units of plastics containers, e.g. to double, triple, quadruple, or multiple units.Unless otherwise specified, all tests specified in this document apply to the plastics container as prepared ready for use.This document is not applicable to plastics containers with an integrated filter.

标准预览图