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YY/T 0681.15-2019 (YY/T0681.15-2019)

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YY/T 0681.15-2019English450 Add to Cart 0--10 minutes. Auto-delivery. Test methods for sterile medical device package -- Part 15: Performance testing of shipping containers and systems YY/T 0681.15-2019 Valid YY/T 0681.15-2019


YY/T 0681.15-2019: PDF in English (YYT 0681.15-2019)
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 when it is received. The organization that
conducts the test can choose any acceptance criteria that suits its purpose. A
feasible approach is to compare the type and extent of damage of the test
sample with the damage that is caused in actual circulation and handling, or
with the test results of similar containers of known transportation history.
7.2 In most cases, the acceptance criteria can be:
Criterion 1 – The product is undamaged;
Criterion 2 – The packaging is intact and undamaged;
Criterion 3 – Criterion 1 plus criterion 2.
In general, this means that the shipping container and its contents are suitable
for normal sale and use after the test cycle is completed. Detailed acceptance
criteria may allow acceptable and prescribed damage to the product or its
packaging. The forms and contents of the acceptance criteria can vary greatly
depending on the specific situation. The method can range from simple
qualified/unqualified judgment to complex quantitative scoring or system
analysis.
8 Procedure
8.1 Define the shipping unit
Use terms such as specification and dimension, weight, and structural style to
describe the shipping unit.
8.2 Determine the assurance level
Specify a level of test strength. This level shall be one of three predetermined
assurance levels. The predetermined level shall be determined based on the
value of the product, the expected level of expected tolerable damage, the
number of shipping units, the information about the transport environment, or
other criteria. When there are no other restrictions, it is recommended to use
the assurance level II. Assurance level I provides a stricter test than assurance
level II. The degree of strictness of the test that is provided by assurance level
III is lower than assurance level II. The assurance levels of each schedule (see
Chapter 10 to Chapter 13) can vary (if known differences exist); the used
assurance level for the test should be reported. See Chapter 16.
8.3 Determine acceptance criteria
Acceptance criteria are related to the expected state of the product and
packaging at the end of the distribution cycle. See Chapter 7.
8.4 Select the distribution cycle
For sterile medical devices, use the distribution cycle in Table 1.
8.5 Prepare the test plan
Develop a test plan for the selected distribution cycle according to the schedule
that is described in Table 1. Obtain the test strength from the corresponding test
schedule. When determining the specific test strength, the selected assurance
level and the physical condition of the shipping unit shall be considered. In this
way, Table 1 will guide the user to develop a detailed test plan, which describes
the exact sequence of inputs that the shipping unit will undergo each test. Refer
to the current test method standards for the instruments and techniques that
are used in the test schedule related to each hazard element.
Note: See Appendix A for examples of sample test methods.
8.6 Select the test sample
See Chapter 5.
8.7 Sample conditioning
See Chapter 6.
8.8 Perform the test
Perform the test according to the test method standards that are specified in
each test schedule and the changes that are given in the special instructions of
each method.
8.9 Evaluate the results
Evaluate the results, so as to determine whether the shipping unit meets the
acceptance criteria. See Chapter 7.
8.10 Document the test results
Document the test results by reporting each step. See Chapter 16.
8.11 Monitor the transportation
If possible, obtain feedback by monitoring the transportation of the container
after the test, so as to ensure that the type and degree of damage obtained by
the laboratory is correlated with the damage that occurs during the actual
distribution cycle. This information is very useful for the future preparation of
test plans for similar shipping containers.
9 Test schedule corresponding to the hazard
The test schedule corresponding to the hazard is shown in Table 2.
Table 2 – Test schedule corresponding to the hazard
Schedule Hazard Test Chapter
A Manual handling
Drop (free fall or vertical impact),
bridge impact (if applicable)
10
C Carrying stacking Compression load 11
E Carrying vibration
Vibration (random vibration and
sinusoidal resonance)
12
F Unconstrained vibration
Subject to repeated vibrations of
specified frequency in multiple
directions
13
I Low pressure hazard Vacuum 14
J Concentrated impact Vertical impact 15
10 Schedule A – manual handling
10.1 Manual handling test is used for the performance test of single container,
small parcel and any shipping container whose weight does not exceed 90 kg
and can be handled manually.
10.2 The test level and test method of this schedule are expected to determine
the ability of the shipping unit to withstand the hazards that are caused by
manual handling (such as loading, unloading, stacking, sorting or pallet loading)
during the distribution cycle. The main hazard of these operations is the impact
caused by falling or throwing. The size, weight and shape of the shipping unit
will affect the degree of these hazards. There are two drop test methods to
choose from, the free fall test and the simulated drop test, both of which produce
similar results.
10.3 The recommended drop height is shown in Table 3; the number of drops,
the drop progress and the impact direction of the shipping unit are shown in
Table 4.
For the test method, see GB/T 4857.5.
Note 1: The test can also be performed according to ASTM D 5276.
See Chapter 6 for conditioning.
Note 2: For the shipping unit, of which the long side of the packaging is at least
915 mm, and the size in the other two directions is less than or equal
to 20% of the longest size, the bridge impact test shall be considered
in accordance with ASTM D 5265.
Table 3 – Drop height corresponding to the shipping weight
In centimeters
11 Schedule C – Carrying stacking
11.1 The test level and test method of this schedule in the distribution cycle are
expected to determine the ability of the shipping unit to withstand the
compression load during storage or transportation. The required load shall
consider the influence of storage time, container arrangement or stacking
method, container strength change, moisture content, temperature, early
handling, transportation, load support method and vibration. For the minimum
load of a typical shipping unit that includes the combined effects of the above
factors, it is recommended to determine the F factor according to the assurance
level that is given in Table 5.
For the test method, see GB/T 4857.4.
Note: The test can also be performed with reference to the method that is
specified in ASTM D 642.
See Chapter 6 for conditioning.
Table 4 – Number of drops, drop progress, impact position of the
shipping unit
Test
schedule
during the
distribution
cycle
Number of
impacts at
the
specified
height
Impact direction
Box Bag or package
Cylindrical
container
1 Top Surface Top
Shipping weight/kg
Assurance level
The first test
schedule
(schedule 1
in Table 1)
Two adjacent
bottom edges
Two sides
Two sides
separated by 90°
Two opposite
bottom corners
Both ends
Bottom edges
separated by 90°
1 Bottom Opposite sides Bottom
The second
test
schedule
(schedule 7
in Table 1)
1 Vertical edge Surface Top
Two adjacent
sides
Both sides
Two sides
separated by 90°
A corner angle and
an adjacent top
edge
Opposite ends
Bottom edges
separated by 90°
1 See Note 1 See Note 1 See Note 1
Note 1: The last impact of the second manual handling test schedule of a distribution
cycle should be twice the specified height or equivalent speed change [this is
the last (6th) drop in the test sequence, not an added drop]. The drop should
be in the direction where the impact is most likely to fall, which is usually the
largest surface or bottom. For the distribution cycle in which the drop may occur
in any direction (that is, when the mechanical sorting small parcel conveyor
belt is used for sorting), the most critical direction, that is, the direction that is
most likely to cause damage, should be selected (refer to ASTM D 5276).
Note 2: For the simulated drop method that uses an impact testing machine, it is
recommended to take the equivalent speed change corresponding to the
specified drop height according to the provisions of ASTM D 5487.
11.2 Use the F factor that is given in Table 5.
Table 5 – F-factor assurance level of the shipping unit
Structure
type
Description
Assurance level
I II III
Corrugated paper, fiberboard or plastic containers,
with or without inner packaging that uses these
materials to withstand pressure; the product does not
bear any load
10.0 7.0 5.0
Corrugated paper, fiberboard or plastic containers,
with rigid spacers (such as wood) in pressure-bearing
inner packaging
6.0 4.5 3.0
The container structure uses materials that are not
sensitive to temperature and humidity other than
corrugated paper, fiberboard or plastic, or the product
directly bears the load, for example, compression
packaging
4.0 3.0 2.0
If the product bears a known fraction of load, calculate the F factor according to
Formula (1):
Where:
P – the load fraction of the product;
FP – the factor of the compression packaging that is given in Table 5 (structure
type 3);
C – the load fraction of the container;
FC – the container factor of the corresponding structure that is given in Table 5.
If a whole pallet is tested under load, the F factor can be reduced by 30%.
11.3 For carrying stacking which is composed of the same shipping unit, load
the shipping unit to the load that is calculated according to Formula (2). Remove
the load within 3 s after reaching the specified value.
Where:
L – calculated load, in Newtons (N);
m – the mass of the shipping unit or a single container, in kilograms (kg);
J – 9.8 N/kg;
H – the maximum transport stacking height (if the carrying stacking height is
unknown, use 2.7 m), in meters (m);
h – the height of the shipping unit or a single container, in meters (m);
F – the factor that considers the combined effect of the above-mentioned
various factors.
11.4 For the delivery environment where the carrying stacking is transported by
LTL that is composed of mixed goods, or small packages, load the shipping unit
to the load value that is calculated according to Formula (3). Remove the load
within 3 s after the load reaches the specified value. If the average
transportation density factor (Mf) of a particular distribution system is not known,
use 160 kg/m3.
Where:
L – calculated load, in Newtons (N);
Mf – transportation density factor, in kilograms per cubic meter (kg/m3);
J – 9.8 N/kg;
l – the length of the shipping unit or a single container, in meters (m);
w – the weight of the shipping unit or a single container, in meters (m);
h – the height of the shipping unit or a single container, in meters (m);
K – 1 m3/m3;
H – the maximum stacking height in transportation (if the carrying stacking
height is unknown, use 2.7 m), in meters (m);
Note: If the H value is unknown, for packages below 13.6 kg with a volume of
0.056 m3 or smaller, when using the less-than-truckload (LTL)
transportation method, reduce the height from 2.7 m to 1.4 m when
calculating the hazard element of the carrying stacking.
F – the factor that considers the combined effect of the above-mentioned
various factors.
12 Schedule E – carrying vibration
12.1 Overview
The test level and test method of this schedule in the distribution cycle are
expected to determine the ability of the shipping unit to withstand the vertical
vibration environment and the dynamic compression force that is generated by
the carrying stacking. The test level and method shall consider factors such as
the amplitude, frequency range, duration and direction of the vibration. There
are two vibration test methods to choose from: random vibration and sinusoidal
vibration. These two methods are not equivalent and will produce different
results. The random test method can better simulate the actual carrying
vibration environment and is the preferred method. The sinusoidal test method,
which is often used in conjunction with the random method, is a means of
determining and observing system resonance. Perform the test in every
possible transport direction (up to three dimensions). 12.2 gives the
recommended strength and duration of the random test; 12.3 gives the
recommended strength and duration of the sinusoidal test.
12.2 Random test
For the test method, see GB/T 4857.23.
See Chapter 6 for conditioning.
12.2.1 It is recommended to use the 60 min highway test plan that is given in
Table 6 and Figure 1; then, use the 120 min air transport test plan that is given
in Table 8 and Figure 3.
12.2.2 If more detailed information about the transportation vibration
environment or the history of damage to the shipping unit can be obtained, it is
recommended to use this information to modify the test schedule. The test time
that is required to reproduce the transport damage depends on the mode of the
damage and the level of vibration. The test time from 30 min to 6 h has been
successfully applied to different packaging types. In the absence of specific
transportation and test experience, it is reasonable to use a test time of 3 h (180
min).
12.2.3 For the highway test plan, it is recommended to use a combination of all
three test levels (low, medium, and high) to better simulate the actual highway
vibration environment. It is recommended to carry out the 1 h (60 min) test
according to the following highway random vibration plan:
1) 40 min for low level;
2) 15 min for medium level;
3) 5 min for high level.
12.2.4 For the carrying vibration test, when there may be more than one
transportation direction, the total vibration duration shall be equally distributed
to each test direction.
Note: When conducting highway tests, assurance level I, assurance level II and
assurance level III are not used.
Table 6 – Power spectral density level of the highway test
Figure 1 – Power spectral density level of the highway test
Table 7 – Power spectral density level of the railway test
Frequency/Hz
Power spectral density/(g2/Hz)
High level Medium level Low level
Root mean square of
acceleration a (grms)
a GB/T 4857.23 gives the definition of the root mean square of acceleration.
Po
er
pe
ct
ra
l d
en
si
ty
(g
2 /H
z)
High level Medium level Low level
Frequency/Hz
Frequency/Hz
Power spectral density/(g2/Hz)
Assurance level I Assurance level II Assurance level III
Root mean square of
acceleration (grms)
Figure 2 – Power spectral density level of the railway test
Table 8 – Power spectral density level of the aviation test
Figure 3 – Power spectral density level of the aviation test
12.3 Sinusoidal test
For the test method, see GB/T4857.10.
Note: Or refer to method B or method C in ASTM D 999-08 for testing.
See Chapter 6 for conditioning.
Po
er
pe
ct
ra
l d
en
si
ty
(g
2 /H
z)
Assurance level I Assurance level II Assurance level III
Frequency/Hz
Frequency/Hz
Power spectral density/(g2/Hz)
Assurance level I Assurance level II Assurance level III
Root mean square of
acceleration (grms)
Po
er
pe
ct
ra
l d
en
si
ty
(g
2 /H
z)
Frequency/Hz
Assurance level I Assurance level II Assurance level III
Special note: Duration refers to the duration of each resonance point of no more
than four discrete resonances that are marked on the product or package. If
there are more than four resonance points, the test shall be carried out at the
four marked frequencies that produce the maximum response. In frequency
scanning, the frequency ranges which are frequently encountered in the
transportation type should be considered. Due to changes in the characteristics
of the container system during the test, the resonance frequency may drift. It is
recommended to change the continuous frequency slightly during the test to
detect any drift, so that the test frequency continues at the maximum response.
Use the test level that is specified in Table 9.
Table 9 – Level of sinusoidal resonance test
Assurance level
Frequency range
Hz
Amplitude (0 - peak) Duration
min Railway Highway
I 3~100 0.25g 0.5g 15
II 3~100 0.25g 0.5g 10
III 3~100 0.25g 0.5g 5
13 Schedule F – Unconstrained vibration
13.1 The test level and test method of this schedule are expected to determine
the ability of the shipping unit to resist revibration during bulk or unconstrained
transport. The amplitude, direction and duration of revibration are considered in
the test level and test method.
13.2 The following test levels are used:
For the test method, see method B in GB/T 4857.7-2005.
Note: Or refer to method A1 or method A2 in ASTM D 999-08 for testing.
See Chapter 6 for conditioning.
Special note: 50% of the duration of this test is allocated to the normal vertical
......
 
(Above excerpt was released on 2021-09-03, modified on 2021-09-03, translated/reviewed by: Wayne Zheng et al.)
Source: https://www.chinesestandard.net/PDF.aspx/YYT0681.15-2019