YY/T 0681.15-2019 PDF English
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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
---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/YYT0681.15-2019
YY
PHARMACEUTICAL INDUSTRY STANDARD
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.
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
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.
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.
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.
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.
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.
5.2 It shall be ensured that the product and packaging are not degraded when
the test package arrives at the test site.
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.
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.
7.2 In most cases, the acceptance criteria can be.
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.
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.
8.6 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.
9 Test schedule corresponding to the hazard
The test schedule corresponding to the hazard is shown in Table 2.
......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.
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