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YY/T 0681.15-2019

Chinese Standard: 'YY/T 0681.15-2019'
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YY/T 0681.15-2019English439 Add to Cart Days<=5 Test methods for sterile medical device package -- Part 15: Performance testing of shipping containers and systems Valid YY/T 0681.15-2019
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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
Test methods for sterile medical device package-Part 15. Performance testing of shipping containers and systems
ICS 11.080.40
C31
People's Republic of China Pharmaceutical Industry Standard
Test methods for sterile medical device packaging
Part 15. Performance testing of transport containers and systems
Published on October 23,.2019
2020-10-01 implementation
Published by the State Drug Administration
Contents
Foreword III
Introduction IV
1 range 1
2 Normative references 1
3 Terms and definitions 1
4 Test progress applicable to the circulation cycle of sterile medical devices 2
5 Test sample 3
6 Condition adjustment and test conditions 3
7 Acceptance criteria 3
8 Procedure 4
8.1 Defining the transport unit 4
8.2 Determining the level of assurance 4
8.3 Determine acceptance criteria 4
8.4 Selecting the circulation period 4
8.5 Writing a Test Plan 4
8.6 Selecting test samples 4
8.7 Sample Condition Adjustment 4
8.8 Test 4
8.9 Evaluation result 4
8.10 Test results documented 4
8.11 Monitoring Transport 4
9 Hazard (source) corresponding test progress 5
10 Process A --- Manual Handling 5
11 Process C --- Carry Stack 6
12 Process E --- Carrying Vibration 7
12.1 Overview 7
12.2 Randomized trials 8
12.3 Sine Test 10
13 Process F --- Unconstrained Vibration 10
14 Process I --- Low Pressure (High Altitude) Danger (Source) 11
15 Process J --- Concentrated Impact 11
16 Report 11
Appendix A (informative) Example of transport test plan 12
Appendix B (Normative) Vacuum Test Method for Determining the Impact of High Altitude on Packaging Systems 14
Appendix C (Normative) Concentrated Impact Test Method for Transport Packaging 16
References 18
Figure 1 Power spectral density levels for road tests 9
Figure 2 Power spectral density levels for railway tests9
Figure 3 Power Spectral Density Level for Aviation Tests
Figure C.1 Impact test head 16
Table 1 Recommended test procedure for sterile medical device transport unit 2
Table 2 Test process corresponding to hazard (source) Table 5
Table 3 Drop height corresponding to transport weight 5
Table 4 Number of drops, fall process, and impact location of the transport unit 6
Table 5 F-factor guaranteed levels of transport units 6
Table 6 Power spectral density levels for road tests 8
Table 7 Power spectral density levels for railway tests 9
Table 8 Power spectral density levels for aviation tests 9
Table 9 Level 10 of the sine resonance test
Table 10 Test levels for unconstrained vibration 11
Table A.1 Transport test plan 13
Foreword
YY/T 0681 `` Test method for packaging of sterile medical devices '', which consists of the following parts.
--- Part 1. Guidelines for accelerated aging tests;
--- Part 2. Seal strength of soft barrier materials;
--- Part 3. Unrestrained packaging resistance to internal pressure damage;
--- Part 4. Determination of leaking seals in breathable packaging by the penetrating dyeing method;
--- Part 5. Detection of coarse leaks by internal pressure method (bubble method);
--- Part 6. Evaluation of chemical resistance of printing inks and coatings on flexible packaging materials;
--- Part 7. Evaluation of ink or coating adhesion on flexible packaging materials with tape;
--- Part 8. Determination of the weight of the coated layer;
--- Part 9. Bursting test of the flexible package sealing by air pressure method inside the restraint plate;
--- Part 10. Microbiological barrier grading test for breathable packaging materials;
--- Part 11. visual inspection of medical packaging seal integrity;
--- Part 12. Soft barrier film rub resistance;
--- Part 13. Slow penetration resistance of soft barrier films and composite films;
--- Part 14. Wet and dry microbial barrier tests on breathable packaging materials;
--- Part 15. Performance testing of transport containers and systems;
--- Part 16. Weathering capacity test of packaging system.
This part is Part 15 of YY/T 0681.
This section is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some elements of this document may involve patents. The issuer of this document is not responsible for identifying these patents.
This section is proposed by the State Drug Administration.
This section is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Devices (SAC/TC106).
This section was drafted by. Shandong Medical Device Product Quality Inspection Center, Shanghai Minimally Invasive Medical Devices (Group) Co., Ltd., Sealed Air
(China) Co., Ltd.
The main drafters of this section. Zhang Peng, Sun Haipeng, Li Yong, Chen Tianyou.
introduction
After the packaging system of the sterile medical device has withstood all expected hazards (sources) during transportation, is the performance of the device delivered to the user satisfactory?
It can meet the expected performance requirements when leaving the factory.It is a problem that users are very concerned about, and it is getting more and more from the producer, user and management.
Value.
This part of YY/T 0681 refers to ASTMD 4169-16 "Standard Specification for Performance Testing of Transport Containers and Systems". The Commission recognized
For this reason, the circulation cycle given in Table 1 in this section (refer to DCMD in ASTMD4169-16) represents the domestic circulation of sterile medical device packaging.
The most severe challenge in the process was therefore identified as the recommended test procedure for this section. Sterile medical devices with special circulation cycles, also
Can refer to the test requirements of other circulation cycles in the ASTMD4169 standard.
Test methods for sterile medical device packaging
Part 15. Performance testing of transport containers and systems
1 Scope
This part of YY/T 0681 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 the user in designing a suitable test scheme to make the transport unit withstand the requirements of a particular circulation cycle.
A series of expected dangers (sources).
This section does not include performance tests for single-package transport packaging.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 4857.2 Packaging and transportation. Basic tests for packages. Part 2. Temperature and humidity conditioning treatment
GB/T 4857.4 Packaging and transportation. Basic tests for packages. Part 4. Compression and stacking tests using pressure testing machines
method
GB/T 4857.5 Drop test method for packaging and transportation packages
GB/T 4857.7-2005 Packaging and packaging. Basic tests for packages. Part 7. Sine fixed frequency vibration test method
GB/T 4857.10 Basic tests for packaging and transporting packages. Part 10. Sine frequency conversion vibration test
GB/T 4857.23 Basic tests for packaging and transport packages. Part 23. Random vibration test method
3 terms and definitions
The following terms and definitions apply to this document.
3.1
Acceptance criteria
An acceptable level of quality that a transport unit must meet after undergoing a test protocol.
3.2
Assurance level
The level of test intensity determined based on the probability of occurrence in a typical circulation cycle.
Note. Guaranteed level Ⅰ is the highest level of test intensity, but the probability of occurrence is low, level Ⅲ is the lowest level of test intensity, but the corresponding probability of occurrence is high, level
The test intensity of II is between level I and level III.
3.3
Distribution cycle; DC
A sequential list of dangerous (source) factors expected to occur in a particular route of a transport unit from production to consumption using a test process.
Note. The circulation cycle given in Table 1 refers to DC13 in ASTMD4169-16.
3.4
Feeder aircraft
Small, non-pressurized aircraft may be used in warehouses that ship packaged shipments.
Related standard:   YY/T 0681.18-2020
Related PDF sample:   YY/T 0681.14-2018  YY/T 0681.12-2014
   
 
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