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YY/T 0681.18-2020

Chinese Standard: 'YY/T 0681.18-2020'
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YY/T 0681.18-2020English439 Add to Cart Days<=5 Test methods for sterile medical device package--Part 18: Nondestructive detection of leaks in packages by vacuum decay method Valid YY/T 0681.18-2020
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BASIC DATA
Standard ID YYT0681.18-2020 (YYT0681.18-2020)
Description (Translated English) Test methods for sterile medical device package--Part 18: Nondestructive detection of leaks in packages by vacuum decay method
Sector / Industry Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard C31
Classification of International Standard 11.080.40
Word Count Estimation 22,225
Date of Issue 2020-03-31
Date of Implementation 2021-04-01
Drafting Organization Shanghai Zhonglin Electromechanical Equipment Co., Ltd., Shandong Medical Device Product Quality Inspection Center, Shanghai MicroPort Medical Devices (Group) Co., Ltd.
Administrative Organization National Technical Committee for Standardization of Medical Infusion Apparatus (SAC / TC 106)
Regulation (derived from) Announcement No. 48 of 2020 by the State Administration of Drug Administration
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration

YY/T 0681.18-2020
Test methods for sterile medical device package--Part 18. Nondestructive detection of leaks in packages by vacuum decay method
ICS 11.080.40
C31
People's Republic of China Pharmaceutical Industry Standard
Sterile medical device packaging test method
Part 18. Non-destructive inspection of packaging leaks by vacuum attenuation method
2020-03-31 release
2021-04-01 Implementation
Issued by the State Drug Administration
Foreword
YY/T 0681 "Test methods for packaging of sterile medical devices", consisting of the following parts.
--- Part 1. Guide to accelerated aging tests;
--- Part 2. Sealing strength of flexible barrier materials;
--- Part 3. Unconstrained packaging resists internal pressure damage;
--- Part 4. Dyeing liquid penetration method to determine the seal leakage of breathable packaging;
--- Part 5. Internal pressure method to detect gross leakage (bubble method);
--- Part 6. Evaluation of chemical resistance of printing inks and coatings on flexible packaging materials;
--- Part 7. Use adhesive tape to evaluate the adhesion of ink or coating on flexible packaging materials;
--- Part 8. Determination of the weight of the adhesive layer;
--- Part 9. Sealing and bursting test of flexible packaging with air pressure method inside the restraining plate;
--- Part 10. Breeding packaging materials microbial barrier grading test.
--- Part 11. Visual inspection of the integrity of medical packaging seals;
--- Part 12. Anti-rubbing properties of the soft barrier film;
--- Part 13. Slow barrier penetration resistance of flexible barrier film and composite film;
--- Part 14. Wet and dry microbial barrier test of breathable packaging materials;
--- Part 15. Performance tests of transport containers and systems;
--- Part 16. Climatic resilience test of packaging system;
--- Part 17. Microbial barrier test of air-permeable packaging material aerosol filtration method;
--- Part 18. Non-destructive inspection of packaging leaks by vacuum attenuation method.
This part is Part 18 of YY/T 0681.
This section was drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some content of this document may involve patents. The issuer of this document does not assume responsibility for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Infusion Apparatus (SAC/TC106).
This section was drafted by. Shanghai Zhonglin Electromechanical Equipment Co., Ltd., Shandong Medical Device Product Quality Inspection Center, Shanghai MicroPort Medical
Instruments (Group) Co., Ltd.
The main drafters of this section. Sheng Honghui, Zhang Peng, Sun Haipeng, Qian Chengyu, Wang Dongwei, Li Ran.
introduction
0.1 Overview
The vacuum attenuation method given in this section is not only applicable to the "package" given in the scope, but can also be extended to the cavity shape with sealing requirements
"Medical devices (such as syringes)" and "components" leak test. The purpose of this part is to expect this inspection technology to be applied to medical devices
In the inspection of mechanical packaging, instruments or components, it provides a higher guarantee for product quality.
0.2 Leaks detected by this test technique
This test method detects package leakage by measuring the pressure rise (vacuum loss) in the closed vacuum test chamber containing the test package. Vacuum loss
The loss is caused by the leakage of the headspace gas of the test package, and/or the volatilization of the liquid contents in the leaked or nearby. When the package
When the contents of the liquid may invade part or all of the packaging at the leak, the test chamber is evacuated to a pressure lower than the vaporization pressure of the liquid.
The test method requires a test chamber containing the test package and a leak detection system designed with one or more pressure sensors.
Appendix A gives the principle of test technology, test cycle and critical parameter terms and definitions.
0.3 Sensitivity of this test technique
Appendix B gives the sensitivity of the test method. Under certain sensitivity conditions, the precision and development of the selected product packaging system
The precision obtained by the bias study is shown in Table C.1 in Appendix C.
Note. Table C.1 also lists examples of other relevant product packaging systems that can be used for vacuum attenuation leak testing.
--- Tray or cup (without cover) (air leakage)
It can detect holes or cracks with a diameter of at least 50 μm on the wall of the tray or cup. Uncovered tray at -4 × 104Pa (-400mbar) mesh
Check under standard vacuum.
--- Tray sealed with breathable barrier cover material (head air leakage)
It can detect holes or cracks with a diameter of at least 100 μm on the wall of the tray or cup. Channel defects in the sealed area (with a diameter of 125 μm
Made of silk) can be detected. Serious sealing and gluing defects in continuous bonding and dot matrix gluing packaging systems can be detected. Obviously endless
Defects in whole dot matrix bonding can also be detected. All breathable barrier cover materials are inspected under a target vacuum of -4 × 104Pa (-400mbar)
Test. Using a calibrated volumetric air flow meter, the test sensitivity of the breathable cover material packaging showed about 10-2Pa · m3 · s-1.
--- Non-breathable rigid packaging (headspace gas leakage)
It can detect hole defects with a diameter of at least 5μm. The plastic bottle with screw cap is measured under the target vacuum of -5 × 104Pa (-500mbar)
For testing, the sensitivity of a calibrated volumetric airflow meter is about 4 × 10-4Pa · m3 · s-1; the glass syringe filled with air is
-7.5 × 104Pa (-750mbar) and 1mbar absolute pressure target vacuum test, measured with a calibrated volume flow meter
The test sensitivity is about 8 × 10-5Pa · m3 · s-1.
--- Non-breathable rigid packaging (liquid leakage)
It can detect hole defects with a diameter of at least 5μm. The detection limit is about 100Pa (1mbar) with multiple glass syringes filled with water
The absolute pressure target was verified under vacuum.
--- Non-breathable flexible packaging (gas or liquid leakage)
This kind of packaging can also be tested by the vacuum attenuation method. Although the vacuum attenuation method is more mature for flexible packaging testing, it is accurate and biased.
Sensitivity data for flexible packaging was not included in the study.
0.4 Test results of this test technique
The test result is qualitative (receive/reject). The acceptance criterion is the quantitative measurement of the baseline vacuum attenuation measured by the non-leakage control package
According to the data, it was established after comparing with the measurement data of the leakage package and the measurement data of the simulated leakage introduced by a calibrated volume flow meter.
Sterile medical device packaging test method
Part 18. Non-destructive inspection of packaging leaks by vacuum attenuation method
1 Scope
This part of YY/T 0681 specifies the test method for non-destructive inspection of leaks in sterile medical device packaging systems by vacuum attenuation.
This section applies to rigid and semi-rigid uncovered trays, trays or cups with breathable barrier cover materials, non-breathable hard packaging, non-breathable soft
package.
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 the cited documents without date, the latest version (including all amendments) applies to this document.
GB/T 19633.1 Final Sterilized Medical Device Packaging Part 1. Requirements for Materials, Sterile Barrier System and Packaging System
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Baseline vacuum attenuation
The degree of vacuum change in the test chamber over time as verified by the leak-free control package.
3.2
Control, non-leaking packages
Non-defective packaging that is properly sealed or closed according to the manufacturer's specifications.
3.3
Non-breathable flexible packaging, flexible, nonporouspackages
Packaging made of stretchable non-breathable material that will deform significantly under vacuum. For example. Groups made of polymeric materials, foils or composite films
Pouches or bags. GB/T 19633.1 gives the test method for non-breathable materials.
3.4
Gas leaks
Leakage channel for gas flowing out from the test package.
3.5
Liquid leakage liquids
Leakage channels that are partially or fully filled with liquid.
3.6
Rigid, nonporouspackages
Packaging made of cured non-breathable material without obvious deformation under vacuum. For example. plastic bottle with threaded mouth or bottle stopper, with elastic
Glass or plastic vials and glass or plastic syringes for sex plugs.
Related standard:   YY/T 0681.15-2019  YY/T 0681.16-2019
Related PDF sample:   YY/T 0681.14-2018  YY/T 0681.12-2014
   
 
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