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YY/T 0681 consists of the following parts under the general title Test methods for sterile medical device package:
——Part 1: Test guide for accelerated aging;
——Part 2: Seal strength of flexible battier materials;
——Part 3: Internal pressurization failure resistance of unrestrained packages;
——Part 4: Detecting seal leaks in porous packages by dye penetration;
——Part 5: Detecting gross leaks in medical packaging by internal pressurization (bubble test);
——Part 6: Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials;
——Part 7: Evaluating inks or coating adhesion to flexible packaging materials using tape;
——Part 8: Coating/adhesive weight determination;
——Part 9: Burst testing of flexible package seals using internal air pressurization weight restraining plates;
——Part 10: Test for microbial barrier ranking of porous package material;
——Part 11: Determining integrity of seals for medical packaging by visual inspection;
——Part 12: Flex durability of flexible barrier films;
——Part 13: Slow rate penetration resistance of flexible barrier films and laminates;
——Part 14: Testing the microbial barrier for porous packaging materials under moist conditions and with passage of air;
——Part 15: Performance testing of shipping containers and systems;
——Part 16: Test for climatic stressing of packaging system.
This is Part 15 of YY/T 0681.
This part is developed in accordance with the rules given in GB/T 1.1-2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This part was proposed by the National Medical Products Administration of People’s Republic of China.
This part is under the jurisdiction of the National Technical Committee 342 on Medical Syringes of Standardization Administration of China.
Introduction
After the packaging system of sterile medical devices has been subjected to all the expected hazards during transportation, whether the performance of the devices delivered to the user still meets the expected performance requirements before delivery is an issue of great concern to the user and is becoming more and more important to manufacturers, users and managers.
This part of YY/T 0681 refers to ASTM D 4169-16 Standard practice for performance testing of shipping containers and systems. The committee concluded that the distribution cycle (referring to DC13 in ASTM D 4169-16) given in Table 1 in this part represents the most severe challenges in the domestic distribution of sterile medical device package and, therefore, is determined as the recommended test procedure for this part. Reference may also be made to the test requirements for other distribution cycles in ASTM D 4169 for sterile medical devices with special distribution cycles.
Test methods for sterile medical device package - Part 15: Performance testing of shipping containers and systems
1 Scope
This part of YY/T 0681 specifies a unified method for evaluating the ability of a sterile medical device shipping unit to withstand the transport environment within a laboratory.
This part is applicable to guidance to the user on the design of an appropriate test plan to subject the shipping unit to a series of anticipated hazards to be experienced during a specific distribution cycle.
This part does not include the performance tests for single parcel transport packages.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 4857.2 Packaging - Basic tests for transport packages - Part 2: Temperature and humidity conditioning
GB/T 4857.4 Packaging - Basic tests for transport packages - Part 4: Compression and stacking tests using a compression tester
GB/T 4857.5 Packaging - Transport packages - Vertical impact test method by dropping
GB/T 4857.7-2005 Packaging - Basic tests for transport packages - Part 7: Sinusoidal vibration test method at constant frequency
GB/T 4857.10 Packaging - Basic tests for transport packages - Part 10: Sinusoidal vibration test method using at variable vibration frequency
GB/T 4857.23 Packaging - Basic tests for transport packages - Part 23: Random vibration test method
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
acceptance criteria
acceptable quality level that must be met after the shipping unit has been subjected to the test plan
3.2
assurance level
level of test intensity based on its probability of occurring in a typical distribution cycle
Note: assurance Level I is the highest level of test intensity and has a low probability of occurrence, Level III is the lowest level of test intensity but has a correspondingly high probability of occurrence, and the test intensity of Level II is intermediate between Level I and Level III.
3.3
distribution cycle; DC
sequential listing of the test schedules employed to simulate the hazard elements expected to occur for a specific routing of a shipping unit from production to consumption
Note: reference has been made to DC 13 in ASTM D 4169-16 for the distribution cycle given in Table 1.
3.4
feeder aircraft
small, potentially non-pressurized aircraft used to transport express packages
3.5
hazard element
specific event that occurs in a distribution cycle that may pose a hazard to a shipping unit, which will usually be simulated by a single test schedule
3.6
less than truckload; LTL
transport situation in which the cargo is less than one full truckload
3.7
shipping unit
smallest complete unit that will be subjected to the distribution environment, for example, a shipping container and its contents
3.8
porous packaging material
material used in medical package to provide an environmental and biological barrier while allowing sufficient airflow in gas sterilization (e.g., ethylene oxide, steam, gas plasma)
3.9
test plan
specific listing of the test sequence to be followed to simulate the hazards anticipated during the distribution cycle of a shipping unit, including the test intensity and number of test items
3.10
test schedule
specific procedure to be used, including the three assurance level intensities, and a reference to the test method that is the basis of the schedule
Note: the purpose of the test schedule is to simulate the stresses occurring during any hazard element of the distribution cycle.
3.11
single parcel
non-standard shipping unit (e.g. parcels of mailing)
4 Test schedule applicable to distribution cycle of sterile medical device
4.1 The transport tests recommended for the transport package of sterile medical devices shall be conducted in sequence according to the test schedule given in Table 1.
Table 1 Recommended test schedule for shipping unit of sterile medical device
Note: reference has been made to ASTM D 4169-16, DC13 for this test schedule. Other distribution cycles may also be selected based on demonstration. Reference may be made to ASTM D 7386 for single parcel transport test.
4.2 The schedule given in Table 1 simulates the various hazards that medical devices are expected to undergo during the transport test. The test schedule is expected to be used for the following:
——used for evaluating the ability of sterile medical device packaging systems (including sterile barriers and protective package) to meet predetermined acceptance criteria after being subjected to the expected transport process.
——serving as a pre-test prior to performance test of a sterile medical device after packaging to evaluate whether the performances of the device in the package still meet the intended clinical requirements after the expected distribution cycle.
4.3 these tests should be performed sequentially on the same shipping unit. For performance tests, this part requires that the shipping unit not be opened until all tests have been completed. If used for other purposes, e.g. package development, the shipping unit may be opened and inspected at various time points in the series of tests, but this may not be able to evaluate the effect of closure on the performance of the container.
Foreword i Introduction iii 1 Scope 2 Normative references 3 Terms and definitions 4 Test schedule applicable to distribution cycle of sterile medical device 5 Test sample 6 Conditioning and test condition 7 Acceptance criteria 8 Procedure 8.1 Define shipping unit 8.2 Establish assurance level 8.3 Determine acceptance criteria 8.4 Select distribution cycle 8.5 Write test plan 8.6 Select samples for test 8.7 Condition samples 8.8 Perform tests 8.9 Evaluate results 8.10 Document test results 8.11 Monitor shipments 9 Test schedules corresponding to hazards 10 Schedule A——Manual handling 11 Schedule C - Vehicle stacking 12 Schedule E - Vehicle vibration 12.1 General 12.2 Random test 12.3 Sine test 13 Schedule F - Loose load vibration 14 Schedule I - Low pressure (High altitude) hazard 15 Schedule J - Concentrated impact 16 Report Annex A (Informative) Example test plans for shipping Annex B (Normative) Vacuum method for determining the effects of high altitude on packaging systems Annex C (Normative) Test method for concentrated impact of transportation package Bibliography Figure 1 Power spectral density levels for truck test Figure 2 Power spectral density levels for rail test Figure 3 Power spectral density levels for air test Figure C.1 Test impact head Table 1 Recommended test schedule for shipping unit of sterile medical device Table 2 Test schedules corresponding to hazards Table 3 Drop heights corresponding to shipping weights Table 4 Number of drops, drop schedule and impact position Table 5 F factors assurance levels for shipping units Table 6 Power spectral density levels for truck test Table 7 Power spectral density levels for rail test Table 8 Power spectral density levels for air test Table 9 Levels for sine resonance test Table 10 Test levels for loose load vibration Table A.1 Transportation test plan
无菌医疗器械包装试验方法 第15部分：运输容器和系统的性能试验 1 范围 YY/T 0681的本部分规定了实验室内评价无菌医疗器械运输单元承受运输环境能力的统一方法。 本部分适用于指导使用者设计一个适宜的试验方案，使运输单元承受特定流通周期中所要经历的一系列预期危险(源)。 本部分不包括单包裹运输包装的性能试验。 2规范性引用文件 下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件，仅注日期的版本适用于本文件。凡是不注日期的引用文件，其最新版本(包括所有的修改单)适用于本文件。 GB/T 4857.2 包装 运输包装件基本试验 第2部分：温湿度调节处理 GB/T 4857.4包装运输包装件基本试验 第4部分：采用压力试验机进行的抗压和堆码试验方法 GB/T 4857.5 包装 运输包装件 跌落试验方法 GB/T 4857.7—2005 包装 运输包装件基本试验 第7部分：正弦定频振动试验方法 GB/T 4857.10包装 运输包装件基本试验 第10部分：正弦变频振动试验方法 GB/T 4857.23 包装 运输包装件基本试验 第23部分：随机振动试验方法 3术语和定义 下列术语和定义适用于本义件。 3.1 接受准则 acceptance criteria 运输单元经受试验方案后必须满足的可接受的质量水平。 3.2 保证水平 assurance level 根据一个典型的流通周期中发生概率所确定的试验强度的水平。 注：保证水平I为最高水平的试验强度，但发生概率低，水平Ⅲ为最低水平的试验强度，但相应的发生概率高，水平Ⅱ的试验强度介于水平I和水平Ⅲ之间。 3.3 流通周期distribution cycle；DC 采用试验进程模拟运输单元从生产到消费的特定路线中预期发生的危险(源)因素的顺序列表。 注：表1给出的流通周期参考ASTM D 4169-16中的DC 13。 3.4 支线飞机feeder aircraft 小型的，用于运输包装快件的仓内可能没有增压的飞机。 3.5 危险(源)因素hazard element 一个流通周期中产生的可能对运输单元造成危险(源)的特定事件。该因素通常通过一个单独的试验进程进行模拟。 3.6 零担运输less than truckload；LTL 货物量不足一整车箱的运输情况。 3.7 运输单元shipping unit 经历流通环境的最小的完整单元，例如，一个运输容器及其内装物。 3.8 透气包装材料porous packaging material 医用包装中使用的用以提供环境和生物学屏障，同时在气体灭菌中(如环氧乙烷、蒸汽、气体等离子体)能使足够的气流通过的材料。 3.9 试验方案test plan 一个特定的试验进程列表，按照该进程表来模拟一个运输单元在流通周期中的预期危险(源)。包括试验强度和试验的项数。 3.10 试验进程test schedule 将要使用的特定程序，包括三个保证水平的强度，和一个试验方法标准编号(即进程的依据)。 注：试验进程的目的是模拟流通周期中所有危险(源)因素产生的应力。 3.11 单包裹single parcel 非标准运输单元(如邮寄包裹)。 4适用于无菌医疗器械的流通周期的试验进程 4.1 推荐无菌医疗器械的运输包装的运输试验按表1给出的试验进程依次进行。 表1 推荐的无菌医疗器械运输单元试验进程 顺序号 1 2 3 4 5 6 7 进程 A C F I E J A 项目名称 人工搬运 运载堆码 无约束振动 低气压 运载振动 集中冲击 人工搬运 注：本试验进程参考ASTM D 4169-16的DC13。若经过论证也可选择其他流通周期。单包裹运输试验可参考ASTM D 7386。
