Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
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
Codeofchina.com is in charge of this English translation. In case of any doubt about the English translation, the Chinese original shall be considered authoritative.
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
S.N. 1 2 3 4 5 6 7
Schedule A C F I E J A
Item name Manual handling Vehicle stacking Loose load vibration Low pressure Vehicle vibration Concentrated impact Manual handling
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.
Contents of YY/T 0681.15-2019
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
