初始化
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GukSang.Jin
@@ -6,25 +6,25 @@ public sealed class StandardRepository : IStandardRepository
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{
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public IReadOnlyList<TestRequirement> GetRequirements() =>
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[
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new() { Clause = "4.1.1", Category = "生物性能", Item = "无菌", Requirement = "插管应无菌", Method = "按 5.2.1 检验", ControlPoint = "灭菌批次放行" },
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new() { Clause = "4.1.2", Category = "生物性能", Item = "细菌内毒素", Requirement = "内毒素不超过 20 EU/件", Method = "按药典方法，5.2.2", ControlPoint = "内毒素检测记录" },
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new() { Clause = "4.1.3", Category = "生物性能", Item = "生物相容性", Requirement = "符合预期用途生物学评价", Method = "YY/T 0771 系列，5.2.3", ControlPoint = "生物学评价记录" },
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new() { Clause = "4.2.1", Category = "物理性能", Item = "血液通道密合性", Requirement = "血液通道不应泄漏", Method = "最大压力 1.5 倍，5.3.1", ControlPoint = "人工保压观察" },
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new() { Clause = "4.2.2", Category = "物理性能", Item = "接头", Requirement = "连接牢固，辅助接头同样满足要求", Method = "15 N 拉力 / 鲁尔接头标准", ControlPoint = "人工拉脱力记录" },
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new() { Clause = "4.2.3", Category = "物理性能", Item = "抗扭结抗性", Requirement = "流量降低不超过 50%", Method = "弯折后流量对比，5.3.3", ControlPoint = "人工填写弯折流量" },
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new() { Clause = "4.2.4", Category = "物理性能", Item = "抗拉强度", Requirement = "承受持续最小拉力且不分离", Method = "1.5 倍预期力，5.3.4", ControlPoint = "拉力试验记录" },
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new() { Clause = "4.2.5", Category = "物理性能", Item = "外观", Requirement = "无毛刺、裂纹、异物、色斑，远端无锐角", Method = "目视检查，5.3.5", ControlPoint = "人工外观复核" },
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new() { Clause = "4.2.6", Category = "物理性能", Item = "完整性", Requirement = "模拟使用后无腐蚀、磨损、塌陷", Method = "模拟使用后放大检查，5.3.6", ControlPoint = "使用后检查" },
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new() { Clause = "4.2.7", Category = "物理性能", Item = "射线可探测性", Requirement = "需具备可探测性时应满足要求", Method = "YY/T 1540", ControlPoint = "影像记录" },
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new() { Clause = "4.2.8", Category = "物理性能", Item = "距离标记", Requirement = "标记应指示至远端距离，间隔不超过 10 mm 或风评值", Method = "目视检查，5.3.8", ControlPoint = "人工核对标记" },
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new() { Clause = "4.2.9", Category = "物理性能", Item = "管腔标记", Requirement = "端口和血流方向可肉眼识别", Method = "目视检查，5.3.9", ControlPoint = "人工核对流向" },
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new() { Clause = "4.1.1", Category = "生物性能", Item = "无菌", Requirement = "插管应无菌", Method = "对灭菌后样品进行无菌培养观察，确认无菌生长", ControlPoint = "灭菌批次放行" },
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new() { Clause = "4.1.2", Category = "生物性能", Item = "细菌内毒素", Requirement = "内毒素不超过 20 EU/件", Method = "提取样液后进行细菌内毒素检测，确认每件结果不超过限值", ControlPoint = "内毒素检测记录" },
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new() { Clause = "4.1.3", Category = "生物性能", Item = "生物相容性", Requirement = "符合预期用途生物学评价", Method = "结合预期用途完成生物学评价并审查评价结论", ControlPoint = "生物学评价记录" },
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new() { Clause = "4.2.1", Category = "物理性能", Item = "血液通道密合性", Requirement = "血液通道不应泄漏", Method = "封闭血液通道并加压至最大工作压力 1.5 倍，保压观察是否泄漏", ControlPoint = "人工保压观察" },
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new() { Clause = "4.2.2", Category = "物理性能", Item = "接头", Requirement = "连接牢固，辅助接头同样满足要求", Method = "对接头和辅助接头施加规定拉力，检查是否松动或脱开", ControlPoint = "人工拉脱力记录" },
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new() { Clause = "4.2.3", Category = "物理性能", Item = "抗扭结抗性", Requirement = "流量降低不超过 50%", Method = "将插管弯折至规定状态，比较弯折前后流量变化", ControlPoint = "人工填写弯折流量" },
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new() { Clause = "4.2.4", Category = "物理性能", Item = "抗拉强度", Requirement = "承受持续最小拉力且不分离", Method = "对连接部位持续施加预期使用力 1.5 倍拉力，观察是否分离", ControlPoint = "拉力试验记录" },
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new() { Clause = "4.2.5", Category = "物理性能", Item = "外观", Requirement = "无毛刺、裂纹、异物、色斑，远端无锐角", Method = "在正常照明下目视检查管体表面、接口和远端外观", ControlPoint = "人工外观复核" },
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new() { Clause = "4.2.6", Category = "物理性能", Item = "完整性", Requirement = "模拟使用后无腐蚀、磨损、塌陷", Method = "完成模拟使用后，对管体和组件进行放大检查", ControlPoint = "使用后检查" },
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new() { Clause = "4.2.7", Category = "物理性能", Item = "射线可探测性", Requirement = "需具备可探测性时应满足要求", Method = "在影像条件下观察插管显影情况和可识别性", ControlPoint = "影像记录" },
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new() { Clause = "4.2.8", Category = "物理性能", Item = "距离标记", Requirement = "标记应指示至远端距离，间隔不超过 10 mm 或风评值", Method = "目视检查距离标记的位置、间距和清晰度", ControlPoint = "人工核对标记" },
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new() { Clause = "4.2.9", Category = "物理性能", Item = "管腔标记", Requirement = "端口和血流方向可肉眼识别", Method = "目视检查端口标识和血流方向标识是否清晰可辨", ControlPoint = "人工核对流向" },
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new()
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{
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Clause = "4.3.1",
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Category = "性能特征",
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Item = "压力降",
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Requirement = "应在制造商声明范围内",
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Method = "额定流量点测量，5.4.1",
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Method = "在额定流量点同步测量入口与出口压力，计算压差",
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ControlPoint = "入口/出口压差",
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CaptureMode = RequirementCaptureMode.RealtimeMonitor,
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MeasurementSource = "入口/出口压力传感器",
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@@ -37,7 +37,7 @@ public sealed class StandardRepository : IStandardRepository
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Category = "性能特征",
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Item = "抗塌陷",
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Requirement = "引流管负压后压降增量不超过 40%",
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Method = "施加负压，5.4.2",
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Method = "施加负压后比较压差增量和流量变化，判断是否塌陷",
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ControlPoint = "负压后人工判定",
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CaptureMode = RequirementCaptureMode.RealtimeAssist,
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MeasurementSource = "负压辅助引流、入口/出口压差趋势",
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@@ -50,7 +50,7 @@ public sealed class StandardRepository : IStandardRepository
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Category = "性能特征",
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Item = "再循环",
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Requirement = "再循环百分比在声明值范围内",
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Method = "双腔回路模型，5.4.3",
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Method = "在双腔回路模型中测量引流与回输流量，计算再循环比例",
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ControlPoint = "三路流量实时计算",
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CaptureMode = RequirementCaptureMode.RealtimeMonitor,
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MeasurementSource = "主泵 / 静脉引流 / 动脉回输流量传感器",
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@@ -63,7 +63,7 @@ public sealed class StandardRepository : IStandardRepository
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Category = "性能特征",
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Item = "血细胞破坏",
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Requirement = "游离血红蛋白增量在声明值范围内",
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Method = "体外循环试验，5.4.4",
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Method = "进行体外循环试验，检测循环前后游离血红蛋白增量",
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ControlPoint = "人工填写 fHb",
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CaptureMode = RequirementCaptureMode.RealtimeAssist,
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MeasurementSource = "游离血红蛋白在线趋势 + 实验室结果",
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@@ -76,23 +76,23 @@ public sealed class StandardRepository : IStandardRepository
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Category = "性能特征",
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Item = "血小板/白细胞减少率",
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Requirement = "应在声明值范围内",
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Method = "体外循环试验，5.4.4",
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Method = "进行体外循环试验，比较循环前后血小板和白细胞计数变化",
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ControlPoint = "人工填写血常规",
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CaptureMode = RequirementCaptureMode.RealtimeAssist,
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MeasurementSource = "白细胞减少率趋势 + 血常规结果",
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ManualEntryHint = "系统用于实时显示趋势，最终血常规结果仍需人工录入。",
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LiveDisplayHint = "实时观察白细胞减少率趋势，最终以检验报告为准。"
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},
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new() { Clause = "4.3.5", Category = "性能特征", Item = "有效期", Requirement = "有效期内应符合标准", Method = "实时或加速老化", ControlPoint = "老化记录" },
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new() { Clause = "4.4.1", Category = "化学性能", Item = "还原物质", Requirement = "高锰酸钾消耗差值 < 2.0 mL", Method = "按 5.5.2", ControlPoint = "人工填写化学结果" },
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new() { Clause = "4.4.2", Category = "化学性能", Item = "金属离子", Requirement = "Ba、Cr、Cu、Pb 总量符合限值", Method = "原子吸收或等效法", ControlPoint = "人工填写金属离子" },
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new() { Clause = "4.4.3", Category = "化学性能", Item = "酸碱度", Requirement = "检验液与空白差值不超过 4.0", Method = "按 5.5.4", ControlPoint = "人工填写 pH" },
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new() { Clause = "4.4.4", Category = "化学性能", Item = "蒸发残渣", Requirement = "不超过规定值", Method = "按 5.5.5", ControlPoint = "人工填写残渣" },
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new() { Clause = "4.4.5", Category = "化学性能", Item = "紫外吸光度", Requirement = "应小于 0.1", Method = "按 5.5.6", ControlPoint = "人工填写 UV" },
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new() { Clause = "4.4.5", Category = "化学性能", Item = "色泽", Requirement = "应无色透明", Method = "目视检查", ControlPoint = "人工外观确认" },
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new() { Clause = "4.5", Category = "残留", Item = "环氧乙烷残留量", Requirement = "EO 残留量不大于 10 mg/kg", Method = "GB/T 14233.1", ControlPoint = "人工填写 EO" },
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new() { Clause = "4.6", Category = "耐蚀性", Item = "金属部件耐蚀性", Requirement = "直接接触血液部位不超过 1 级", Method = "YY/T 0149", ControlPoint = "耐蚀性记录" },
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new() { Clause = "4.7", Category = "清洁度", Item = "污染指数", Requirement = "污染指数不超过 90", Method = "YY/T 0328", ControlPoint = "人工填写污染指数" }
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new() { Clause = "4.3.5", Category = "性能特征", Item = "有效期", Requirement = "有效期内应符合标准", Method = "对实时或加速老化样品复测关键性能，评价有效期内是否仍满足要求", ControlPoint = "老化记录" },
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new() { Clause = "4.4.1", Category = "化学性能", Item = "还原物质", Requirement = "高锰酸钾消耗差值 < 2.0 mL", Method = "制备检验液后比较高锰酸钾消耗量与空白液差值", ControlPoint = "人工填写化学结果" },
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new() { Clause = "4.4.2", Category = "化学性能", Item = "金属离子", Requirement = "Ba、Cr、Cu、Pb 总量符合限值", Method = "制备浸提液后测定钡、铬、铜、铅总量", ControlPoint = "人工填写金属离子" },
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new() { Clause = "4.4.3", Category = "化学性能", Item = "酸碱度", Requirement = "检验液与空白差值不超过 4.0", Method = "测量检验液与空白液的 pH 差值", ControlPoint = "人工填写 pH" },
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new() { Clause = "4.4.4", Category = "化学性能", Item = "蒸发残渣", Requirement = "不超过规定值", Method = "蒸干检验液并称量残渣，确认结果不超过限值", ControlPoint = "人工填写残渣" },
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new() { Clause = "4.4.5", Category = "化学性能", Item = "紫外吸光度", Requirement = "应小于 0.1", Method = "测量检验液在规定波长下的紫外吸光度", ControlPoint = "人工填写 UV" },
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new() { Clause = "4.4.5", Category = "化学性能", Item = "色泽", Requirement = "应无色透明", Method = "目视观察检验液颜色和澄清度", ControlPoint = "人工外观确认" },
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new() { Clause = "4.5", Category = "残留", Item = "环氧乙烷残留量", Requirement = "EO 残留量不大于 10 mg/kg", Method = "对样品提取后测定环氧乙烷残留量，确认不超过限值", ControlPoint = "人工填写 EO" },
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new() { Clause = "4.6", Category = "耐蚀性", Item = "金属部件耐蚀性", Requirement = "直接接触血液部位不超过 1 级", Method = "对金属部件进行耐蚀性试验并按腐蚀等级判定", ControlPoint = "耐蚀性记录" },
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new() { Clause = "4.7", Category = "清洁度", Item = "污染指数", Requirement = "污染指数不超过 90", Method = "收集样品污染物并计算污染指数", ControlPoint = "人工填写污染指数" }
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];
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public IReadOnlyList<TraceEvent> GetSeedTraceEvents() =>
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