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YY/T 0681.15-2019 (YYT 0681.15-2019)

Chinese standards (related to): 'YY/T 0681.15-2019'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)See DetailStatusGoogle Book
YY/T 0681.15-2019English450 Add to Cart 0--10 minutes. Auto immediate delivery. Test methods for sterile medical device package -- Part 15: Performance testing of shipping containers and systems YY/T 0681.15-2019 Valid YYT 0681.15-2019
YY/T 0681.1-2018English205 Add to Cart 0--10 minutes. Auto immediate delivery. Test methods for sterile medical device package--Part 1: Test guide for accelerated aging YY/T 0681.1-2018 Valid YYT 0681.1-2018
YY/T 0681.1-2009English419 Add to Cart Days<=3 Test methods for sterile medical device package. Part 1: Test guide for accelerated aging YY/T 0681.1-2009 Obsolete YYT 0681.1-2009


   
BASIC DATA
Standard ID YY/T 0681.15-2019 (YY/T0681.15-2019)
Description (Translated English) Test methods for sterile medical device package -- Part 15: Performance testing of shipping containers and systems
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C31
Classification of International Standard 11.080.40
Word Count Estimation 23,279
Date of Issue 2019-10-23
Date of Implementation 2020-10-01
Quoted Standard GB/T 4857.2; GB/T 4857.4; GB/T 4857.5; GB/T 4857.7-2005; GB/T 4857.10; GB/T 4857.23
Drafting Organization Shandong Medical Device Product Quality Inspection Center, Shanghai Minimally Invasive Medical Devices (Group) Co., Ltd., Sealed Air (China) Co., Ltd.
Administrative Organization National Medical Infusion Device Standardization Technical Committee (SAC / TC 106)
Regulation (derived from) Announcement of the State Drug Administration No. 84 of 2019
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration
Summary This standard specifies a uniform method for evaluating the ability of a sterile medical device transport unit to withstand the transport environment in a laboratory. This section is applicable to guide users to design a suitable test scheme to make the transport unit withstand a series of expected dangers (sources) to be experienced in a specific circulation cycle. This section does not include performance tests for single-package transport packaging.


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 elem......