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YY/T 0681.15-2019: Test methods for sterile medical device package -- Part 15: Performance testing of shipping containers and systems
YY/T 0681.15-2019
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.080.40
C 31
Test methods for sterile medical device package - Part
15: Performance testing of shipping containers and
systems
ISSUED ON: OCTOBER 23, 2019
IMPLEMENTED ON: OCTOBER 01, 2020
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 4 
Introduction ... 6 
1 Scope ... 7 
2 Normative references ... 7 
3 Terms and definitions ... 8 
4 Test schedule applicable to the distribution cycle of sterile medical devices
... 10 
5 Test sample ... 10 
6 Conditioning and test conditions ... 11 
7 Acceptance criteria ... 12 
8 Procedure ... 12 
8.1 Define the shipping unit ... 12 
8.2 Determine the assurance level ... 12 
8.3 Determine acceptance criteria... 13 
8.4 Select the distribution cycle ... 13 
8.5 Prepare the test plan ... 13 
8.6 Select the test sample ... 13 
8.7 Sample conditioning ... 13 
8.8 Perform the test ... 13 
8.9 Evaluate the results ... 13 
8.10 Document the test results ... 13 
8.11 Monitor the transportation ... 13 
9 Test schedule corresponding to the hazard ... 14 
10 Schedule A – manual handling ... 14 
11 Schedule C – Carrying stacking ... 15 
12 Schedule E – carrying vibration ... 18 
12.1 Overview ... 18 
12.2 Random test ... 19 
12.3 Sinusoidal test ... 21 
13 Schedule F – Unconstrained vibration ... 22 
14 Schedule I – low pressure (high altitude) hazards ... 23 
15 Schedule J – Concentrated impact ... 23 
16 Report ... 23 
Appendix A (Informative) Examples of transport test plans ... 25 
Appendix B (Normative) Vacuum test method to determine the impact of high
altitude on the packaging system ... 28 
Appendix C (Normative) Transport package concentrated impact test method
... 30 
References ... 33 
Foreword
YY/T 0681 "Test methods for sterile medical device package" consists of the
following parts:
-- 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 Part is Part 15 of YY/T 0681.
This Part was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents.
The issuing organization of this document is not responsible for identifying
these patents.
This Part was proposed by National Medical Products Administration.
This Part shall be under the jurisdiction of National Technical Committee 106
on Medical Syringes of Standardization Administration of China (SAC/TC 106).
The drafting organizations of this Part: Shandong Quality Inspection Center for
Medical Devices, Shanghai MicroPort Medical (Group) Co., Ltd., Sealed Air
(China) Co., Ltd.
The drafters of this Part: Zhang Peng, Sun Haipeng, Li Yong, Chen Tianyou.
Introduction
After the packaging system of sterile medical devices has withstood all the
expected hazards (sources) in the transportation process, whether the
performance of the devices that are delivered to the user can still meet the
expected performance requirements at the factory is a problem that users are
very concerned about, which gains more and more attention of producers,
users and the management.
This Part of YY/T 0681 refers to ASTM D 4169-16 "Standard Practice for
Performance Testing of Shipping Containers and Systems". The committee
believes that the distribution cycle which is given in Table 1 of this Part (refer to
DC13 in ASTM D 4169-16) represents the strictest challenge in the domestic
distribution process of sterile medical device package. Therefore, it is
determined to be the recommended test schedule for this Part. For sterile
medical devices of special distribution cycles, the test requirements for other
distribution cycles in the ASTM D 4169 standard can also be referred to.
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 uniform method for evaluating the ability of
sterile medical device shipping units to withstand the transport environment in
the laboratory.
This Part is used for guiding the user to design an appropriate test plan, so that
the shipping unit can withstand a series of expected hazards to be experienced
in a specific distribution cycle.
This Part does not include performance testing of single parcel transport
packages.
2 Normative references
The following documents are indispensable for the application of this document.
For dated references, only the dated version applies to this document. For
undated references, the latest edition (including all amendments) applies to this
document.
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
The following terms and definitions are applicable to this document.
3.1
Acceptance criteria
The acceptable quality level that the shipping unit must meet after being
subjected to the test plan.
3.2
Assurance level
The level of test strength that is determined according to the probability of
occurrence in a typical distribution cycle.
Note: The assurance level I is the highest level of test strength, but the
probability of occurrence is low; the level III is the lowest level of test
strength, but the corresponding probability of occurrence is high; the test
strength of level II is between level I and level III.
3.3
Distribution cycle; DC
The sequence list that uses the test schedule to simulate the hazard elements
that are expected to occur in the specific route of the shipping unit from
production to consumption.
Note: The distribution cycle which is given in Table 1 refers to DC 13 in ASTM
D 4169-16.
3.4
Feeder aircraft
The light aircraft that may not be pressurized in the warehouse, which is used
to transport the packaged express.
3.5
Hazard element
A specific event that may cause hazards to the shipping unit, which is generated
during a distribution cycle. This element is usually simulated through a separate
test schedule.
3.6
Less than truckload; LTL
The transportation where the volume of goods is less than a truckload.
3.7
Shipping unit
The smallest complete unit that is subjected to the distribution environment,
such as a shipping container and its contents.
3.8
Porous packaging material
Materials that are used in medical packaging to provide environmental and
biological barriers, and which, at the same time, allow sufficient airflow to pass
through in gas sterilization (such as ethylene oxide, steam, gas plasma).
3.9
Test plan
A specific list of test schedules, which is used to simulate the expected hazard
of a shipping unit in the distribution cycle. It includes the test strength and the
number of test items.
3.10
Test schedule
The specific procedure to be used, including the strength of three assurance
levels, and a test method standard number (that is, the basis of the schedule).
Note: The purpose of the test schedule is to simulate the stress that is
generated by all hazard elements in the distribution cycle.
3.11
Single parcel
A non-standard shipping unit (such as a mailing package).
4 Test schedule applicable to the distribution cycle of
sterile medical devices
4.1 The recommended transport test of transport packages of sterile medical
devices shall be carried out in sequence according to the test schedule that is
given in Table 1.
Table 1 – Test schedule of the recommended sterile medical device
shipping unit
Sequence
number
1 2 3 4 5 6 7
Schedule A C F I E J A
Item
name
Manual
handling
Carrying
stacking
Unconstrained
vibration
Low
pressure
Carrying
vibration
Concentrated
impact
Manual
handling
Note: This test schedule refers to DC13 of ASTM D 4169-16. If proved, other distribution cycles can be
selected. For single parcel transportation test, refer to ASTM D 7386.
4.2 The schedule which is given in Table 1 simulates the various hazards that
the medical device is expected to experience during the transportation test. The
test schedule is expected to be used in the following areas:
-- Used to evaluate whether the sterile medical device packaging system
(including sterile barriers and protective packaging) meet the ability of the
predetermined acceptance criteria after bearing the expected
transportation process;
-- As a pre-test before the performance test of sterile medical devices after
loading and packaging, it is used to evaluate whether all the performances
of the internal devices still meet the expected clinical requirements after
the expected distribution cycle.
4.3 These tests should be carried out sequentially on the same shipping unit.
For performance tests, this Part requires that the shipping unit is not opened
before all tests are completed. If used for other purposes, such as packaging
development, the shipping unit can be opened and inspected at each time point
of the series of tests, but this may not be able to evaluate the impact of closure
on the performance of the container.
5 Test sample
5.1 The test sample consists of representative and complete samples of the
shipping unit, including the actual contents. For valuable medical devices, if
there is no need to conduct experimental research on the defects of the
contents, and the defects have been recorded in the report, products of flaws
or small defects can be used. If the test on the actual product may be dangerous,
a simulated device can be used as the test load. If a simulated load is used, it
should be measured to determine whether it exceeds the fragility level of the
actual product. The loading characteristics of actual product shall be carefully
simulated and unnecessary collisions shall be avoided.
5.2 It shall be ensured that the product and packaging are not degraded when
the test package arrives at the test site. If the state of the packaging is
questionable, new packaging materials shall be used to repackage the product
before the test.
5.3 The number of tests performed depends on the intended purpose of the test
and the availability of the same product and shipping container.
6 Conditioning and test conditions
The samples shall be tested under standard atmospheric conditions; the
influence of any climatic conditions shall be compensated. Unless other
temperature and relative humidity conditions are considered more appropriate,
the shipping unit shall be placed in the standard atmosphere, where the
temperature is (23±2) °C and the relative humidity is (50±2) %, as specified in
GB/T 4857.2, for conditioning. The same atmospheric conditions shall be used
for all assurance levels. It is recommended to use a 72-h conditioning period,
or a time sufficient for all parts of the product and packaging to reach equilibrium.
The test should be performed under the conditioning atmosphere as much as
possible. If not, the test shall be performed as soon as possible after the sample
is taken out from the conditioning environment. If necessary, re-condition the
shipping unit during the test plan.
Note: In some special transportation environments, all tests can be carried out
in accordance with other atmospheric conditions that are given in GB/T
4857.2. The same atmospheric conditions shall be used for all assurance
levels. The duration of the conditioning shall be sufficient to allow all parts
of the product and packaging to reach equilibrium. The test should be
performed under the conditioning atmosphere as much as possible. If
not, the test shall be performed as soon as possible after the sample is
taken out from the conditioning environment. For the non-standard
conditioning atmosphere, the user shall determine the compression load
factor of the corresponding vehicle stacking. The factors which are given
in Table 5 of 11.2 are based on the test under the standard test
atmosphere.
7 Acceptance criteria
7.1 Acceptance criteria shall be established before the test; the required state
of the product should be considered whe...