YY/T 0681.15-2019 English PDF (YYT0681.15-2019)

Delivery: 3 seconds. Download true-PDF + Invoice.
Get QUOTATION in 1-minute: Click YY/T 0681.15-2019
Historical versions: YY/T 0681.15-2019
Preview True-PDF (Reload/Scroll if blank)

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 ...