医疗器械注册产品标准YZBYZB/X XXXX-XXXX 一次性使用真空采血管 发布 实施 Ι 目 次 目 次 ..............................................................................Ι 前 言 ..............................................................................Ⅱ 一次性使用真空采血管 ...................................................................1 1 范围 .................................................................................1 2 规范性引用文件 .......................................................................1 3 分类 .................................................................................1 3.1 分类 ...............................................................................1 3.2 型号规格 ...........................................................................1 3.3 产品结构 ...........................................................................2 4 要求 .................................................................................3 4.1 物理性能 ...........................................................................3 4.2 化学性能 ...........................................................................3 4.3 生物性能 ...........................................................................4 5 检验方法 .............................................................................4 5.1 物理性能 ...........................................................................4 5.2 化学性能检验 .......................................................................4 5.3 生物性能 ...........................................................................5 6 检验规则 .............................................................................5 6.1 出厂检验 ...........................................................................5 6.2 型式检验 ...........................................................................5 7 标签、说明书 ...........................................
