YY/T 0681.9-2011 English PDFUS$299.00 ยท In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. 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 Status: Valid
Basic dataStandard 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---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order. 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 ForewordYY/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 seal1 ScopeTest 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 referencesThe 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-sabotage3 Terms and DefinitionsThe 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 Method4.1 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. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0681.9-2011_English be delivered?Answer: Upon your order, we will start to translate YY/T 0681.9-2011_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. 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