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YY/T 0681.16-2019 English PDF (YYT0681.16-2019)

YY/T 0681.16-2019 English PDF (YYT0681.16-2019)

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YY/T 0681.16-2019: Test methods for sterile medical device package - Part 16: Test for climatic stressing of packaging system

This Part of YY/T 0681 specifies the unified benchmark for evaluating the capability of the sterile medical device packaging system to protect the product from damage or change under the climatic stressing that the sterile medical device packaging system may withstand during the circulation cycle in the laboratory. This Part is applicable as an independent test for evaluating the climatic resilience of the packaging system; it is also applicable as a method of conditioning the packaging system as a single package before the test required for overnight or two-day supply. This Part does not apply to the climatic resilience test of refrigerated, frozen or low-temperature storage and transportation packaging systems.
YY/T 0681.16-2019
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.080.040
C 31
Test Methods for Sterile Medical Device Package - Part 16:
Test for Climatic Stressing of Packaging System
ISSUED ON: MAY 31, 2019
IMPLEMENTED ON: JUNE 1, 2020
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Terms and Definitions ... 5
3 Overview ... 5
4 Significance and Application ... 5
5 Instruments ... 6
6 Specimens ... 6
7 Procedures ... 6
8 Report ... 7
Bibliography ... 9
Foreword
YY/T 0681 Test Methods for Sterile Medical Device Package is composed of the following parts:
---Part 1: Test Guide for Accelerated Aging;
---Part 2: Seal Strength of Flexible Barrier 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 Materials; ---Part 11: Determining Integrity of Seals for Medical Packaging by Visual Inspection; ---Part 12: Flex Durability of Flexible Barrier Materials;
---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 is Part 16 of YY/T 0681.
This Part was drafted in accordance with the rules provided in GB/T 1.1-2009. Please be noted that certain content of this document may involve patents. The institution issuing this document does not undertake the responsibility of identifying these patents. This Part was proposed by National Medical Products Administration.
Test Methods for Sterile Medical Device Package - Part 16:
Test for Climatic Stressing of Packaging System
1 Scope
This Part of YY/T 0681 specifies the unified benchmark for evaluating the capability of the sterile medical device packaging system to protect the product from damage or change under the climatic stressing that the sterile medical device packaging system may withstand during the circulation cycle in the laboratory.
This Part is applicable as an independent test for evaluating the climatic resilience of the packaging system; it is also applicable as a method of conditioning the packaging system as a single package before the test required for overnight or two-day supply. This Part does not apply to the climatic resilience test of refrigerated, frozen or low-temperature storage and transportation packaging systems.
2 Terms and Definitions
The following terms and definitions are applicable to this document.
2.1 Climatic Stressing
Expose the test sample of the packaging system to temperature and humidity conditions for a specified period of state adjustment, thereby simulating the expected storage and circulation system conditions.
3 Overview
The devices transported in the circulation environment (regardless of the mode of transportation) will experience various climatic and physical environments when they are transported to various places (especially import and export) during various time periods of the year. This Part is designed to provide guidelines for the establishment of climate stressing on the packaging system due to climatic conditions and durations that may be encountered during transportation, so as to evaluate the capability of packaging to protect the contents or devices during circulation. 4 Significance and Application
This Part provides a method of state adjustment of the packaging system with the climatic conditions that occur in the actual circulation process. The recommended exposure levels are based on available information on transportation, handling and storage environment, current industrial practices and published studies, etc. These conditions are not absolute extremes, but they are averages for daily records of cold and hot climates around the world. 5 Instruments
5.1 Chamber (or box), whose specifications can be such that the individual sample container or package is exposed to the circulating air at a selected temperature and humidity. 5.2 Control instrument, which can maintain the indoor environment within the allowable limits of the required environmental conditions (see Table 1).
5.3 Hygrometer, which is an instrument used to indicate relative humidity, and its relative humidity precision should be ??? 2%. The psychrometer can be used to directly measure the relative humidity and check the hygrometer.
5.4 Thermometer: temperature measuring devices with an accuracy of 0.1 ???C can be used. The dry bulb thermometer of the psychrometer can be used to directly measure or check the temperature indicator.
6 Specimens
6.1 The specimens should include representative packaging systems, including actual contents or devices. Defective or lesser defective contents can be used, provided that the defect is not within the scope of the study and is recorded in the report. Simulated contents may also be used, provided that they have the same loading characteristics as the actual contents. 6.2 Care shall be taken to ensure that the packaging system and its contents have not degraded prior to exposure to climatic stressing. This is especially important when samples need to be sent to a distant test site.
7 Procedures
7.1 In accordance with specifications, weight and constituent materials, describe the packaging system and confirm the test units (shipping case, multipack and palletized load, etc.). 7.2 Identify the various modes and durations of transportation used for storage and circulation of products to customers. For example, products will be delivered to their destinations by two- day transit period by road and air.
7.3 When used in an independent test, pre-determine the acceptance criteria. 7.4 Use the sequence, conditions and exposure times provided in Table 1 to compile a test protocol. If the conditions and exposure times of the user?€?s circulation environment are known to be different from those specified in Table 1, then, the user?€?s circulation conditions should be

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