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Free Fu | Technical Manager | 2024/07
医疗器械模拟运输
ASTM D4169 DC13
测试方法及要求
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Contents 目录
▪ 背景简介
▪ ASTM D4169 (DC13) 介绍
▪ ASTM D4169 (DC13) 22版和23版的区别
▪ 案例分析
▪ Q&A
Solar Panel Inspection, Belgium
© SGS Société Générale de Surveillance SA. (2024)
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▪ 包装有效性验证
• 模拟运输试验是最重要且有效的方式
• 在医疗器械及药品领域，尤为突出和重要
▪ ASTM D4169: Standard Practice for Performance Testing of Shipping Containers and
Systems
• FDA最早认可的包装运输测试标准
• 公认的评价包装运输性能相对完善的试验体系，运输过程包含空运和低气压敏感包装验证
背景介绍
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ASTM D4169-23
▪ Standard Practice for Performance Testing
of Shipping Containers and Systems
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Distribution Cycle Schedule
DC 1: General Cycle
—undefined distribution system
Schedule A, D, F, G, J, A
DC 2: Specially defined distribution system, user specified
Schedule A~I
DC 3: Single package without pallet or skid, LTL motor freight
Schedule A, D or C+E, F, J, A
DC 4:Single package with pallet or skid, LTL motor freight
Schedule A, D or C+E, F, J, A
DC 5: Motor freight, TL, not unitized
Schedule A, D, E, J, A
DC 6: Motor freight, TL, or LTL
—unitized
Schedule A, D or C+E, J, A, B
DC 7: Rail only, bulk loaded
Schedule A, D, G, A
DC 8: Rail only, unitized
Schedule A, D, G, A, B
DC 9: Rail and motor freight, not unitized
Schedule A, C, E, G, F, J, A
DC 10: Rail and motor freight, unitized
Schedule A, D, G, J, A, B
DC 11: Rail, TOFC and COFC
Schedule A, G, D, F, A
DC 12: Air
(intercity) and motor freight (local), over 150 lb (68.1kg), or unitized
Schedule A, D, I, E, J, A
DC 13: Air (intercity) and motor freight (local), single package up to 150
lb (68.1kg)
Schedule A, C, F, I, E, J, A
DC 14: Warehousing (partial cycle to be added to other cycles as needed)
Schedule A, B
DC 15: Export/Import shipment for intermodal container or roll on/roll off trailer (partial cycle to be added to other cycles
as needed)
Schedule A, C, A
DC 16: Export/Import shipment for palletized cargo ship (partial cycle to be added to other cycles as needed)
Schedule A, C, A
DC 17: Export/Import shipment for break bulk cargo ship (partial cycle to be added to other cycles as needed)
Schedule A, C, A
DC 18: Non
-Commercial Government shipments per MIL-STD-2073-1
▪ ASTM D 4169 规定了18个流通周期(DC: Distribution Cycle)
▪ 每个流通周期由不同的进程(Schedule)组合而成
ASTM D4169 测试前确认信息