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YY/T 0681.9-2011: Test methods for sterile medical device package. Part 9: Burst testing of flexible package seals using internal air pressurization weight restraining plates
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| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0681.9-2011 | English | 299 |
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Test methods for sterile medical device package. Part 9: Burst testing of flexible package seals using internal air pressurization weight restraining plates
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YY/T 0681.9-2011
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Basic data | Standard ID | YY/T 0681.9-2011 (YY/T0681.9-2011) | | Description (Translated English) | Test methods for sterile medical device package. Part 9: Burst testing of flexible package seals using internal air pressurization weight restraining plates | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C31 | | Classification of International Standard | 11.080.040 | | Word Count Estimation | 13,111 | | Date of Issue | 2011-12-31 | | Date of Implementation | 2013-06-01 | | Quoted Standard | YY/T 0681.2; YY/T 0681.3 | | Adopted Standard | ASTM F2054-2000, MOD | | Regulation (derived from) | State Food and Drug Administration Notice 2011 No. 106; industry standard filing Notice 2013 No. 6 (No. 162 overall) | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the flexible plate is placed constraints to test its internal pressure is at a minimum bursting strength peripheral sealing method. This test only applies to a flexible peripheral seal (usually a combination bag). Especially for its peelable seal has characterized (by the end-user peel, remove contents) packaging. | YY/T 0681.9-2011: Test methods for sterile medical device package. Part 9: Burst testing of flexible package seals using internal air pressurization weight restraining plates
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Test methods for sterile medical device package.Part 9. Burst testing of flexible package seals using internal air pressurization weight restraining plates
ICS 11.080.040
C31
People's Republic of China pharmaceutical industry standards
Test methods for packaging sterile medical devices
Part 9. constraint plate method flexible internal pressure
Bursting test seal
Part 9. Bursttestingofflexiblepackagesealsusinginternalair
Issued on. 2011-12-31
2013-06-01 implementation
State Food and Drug Administration issued
Foreword
YY/T 0681 "sterile medical devices packaging materials, test methods", consists of the following components.
--- Part 1. accelerated aging test guidelines;
--- Part 2. sealing strength flexible barrier material;
--- Part 3. Unconstrained pressure within the package of anti-sabotage;
--- Part 4. Determination of staining solution penetrate breathable packaging seal leakage;
--- Part 5. coarse leak was detected internal pressure (bubble method);
--- Part 6. flexible packaging material and ink coating chemical resistance evaluation;
--- Part 7. Evaluation of flexible packaging material with adhesive tape or coating ink fastness;
--- Part 8. coating layer weight determination;
--- Part 9. constraint plate internal pressure bursting test method flexible seal;
--- Part 10. Classification breathable packaging material and microbial tests.
This section YY/T Section 90681 of.
This section drafted in accordance with GB/T 1.1-2009 given rules.
YY/T 0681 Part revised adoption ASTMF2054-00 "constraint-board internal pressure bursting test method flexible sealing methods."
This part is proposed by the State Food and Drug Administration.
This part of the National Technical Committee of Standardization for medical infusion set (SAC/TC106) centralized.
This section is drafted. Shandong Medical Devices Product Quality Inspection Center, Ltd. Shandong Xinhua.
Drafters of this section. Cheng Yu Qian, Zhang Jing, in Xiaohui, Zhong Wenquan.
Test methods for packaging sterile medical devices
Part 9. constraint plate method flexible internal pressure
Bursting test seal
1 Scope
Test methods YY/T 0681 provisions of this section, the provisions of the flexible plate is disposed within the constraints of internal pressure to test its periphery
The minimum bursting strength of a seal.
This test applies only to the periphery of the flexible seal (usually a combination of the bag). Especially for its peelable seal has characterized (by the end
Remove the peel after a user contents) packaging.
This method is recommended for users to pay special attention may be required to design and production constraints board fixture. About stress factors and structural design considerations
See Informative Annex C.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
YY/T 0681.2 Test methods for packaging sterile medical devices - Part 2. seal strength of flexible barrier material
YY/T 0681.3 Test methods for packaging sterile medical devices - Part 3. Unconstrained pressure within the package of anti-sabotage
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Or a combination of flexible packaging bags flexiblepackage
Sealing the packaging material on at least one flexible packaging structure (e.g., paper, polyethylene, etc.).
3.2
Constraints board restrainingplates
When the package to be made into pressure contact with the surface of the packaging and rigid panels restrict expansion.
4 Summary of Test Method
4.1 on a single instrument for the test pressure inside the package is filled until the packing breakage. In most cases rupture occurred in a sealed area or
Several. Inflatable and pressure equipment requirements increase to maintain the internal pressure before the seal is broken. In the pressurization process, the packaging should be placed in two
Between rigid parallel plates (plate bound), to limit the expansion and deformation of the packaging, but so that the sealing surrounding area unconstrained. An insert inside the package
A sensor for detecting the internal pressure of the package rupture. Depending on the application, this test method requires the use of two configurations restricting plate, described
as follows.
4.1.1 opening packaging configurations. three for the peripheral seal, the fourth side open packaging. This configuration is commonly used in the production of preformed packaging.
Configuration uses described in Figure 1.
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