YY/T 0729.2-2009 English PDFUS$259.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0729.2-2009: Test methods for bonding properties of tissue adhesives. Part 2: Strength in T-peel by tension loading Status: Valid
Basic dataStandard ID: YY/T 0729.2-2009 (YY/T0729.2-2009)Description (Translated English): Test methods for bonding properties of tissue adhesives. Part 2: Strength in T-peel by tension loading Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C48 Classification of International Standard: 11.120.20 Word Count Estimation: 11,110 Date of Issue: 2009-06-16 Date of Implementation: 2010-12-01 Quoted Standard: GB/T 16825.1 Adopted Standard: ASTM F 2256-2005, MOD Regulation (derived from): Industry standard filing Notice 2009 No. 9 Issuing agency(ies): State Food and Drug Administration Summary: This standard applies to tissue adhesive or sealant tissue adhesive on the adhesive strength of the soft tissue to provide comparable means. Select the applicable base method, this section can be used for the manufacture of tissue adhesive quality control. YY/T 0729.2-2009: Test methods for bonding properties of tissue adhesives. Part 2: Strength in T-peel by tension loading---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 bonding properties of tissue adhesives.Part 2. Strength in T-peel by tension loading ICS 11.120.20 C48 People's Republic of China pharmaceutical industry standards Tissue adhesive bonding performance test method Part 2. T- peel strength tensile carrier Posted 2009-06-16 2010-12-01 implementation State Food and Drug Administration issued ForewordYY/T 0729 "tissue adhesive bonding performance test method", it includes the following components. --- Part 1. Lap - bearing shear tensile strength; Part --- Article 2. T- peel bearing tensile strength; --- Part 3. Tensile strength; --- Part 4. wound closure strength. This section YY/T Section 20729 of. The partial modification using ASTMF2256-05 "Standard Test Method for strength T- peel tissue adhesive tensile bearer", and ASTM F2256-05 no technical difference. Appendix A to this part of the normative appendix, Appendix B is an informative annex. This section is proposed and managed by the State Food and Drug Administration Jinan Medical Device Quality Supervision and Inspection Center. This section is drafted. Shandong Medical Devices Product Quality Inspection Center. The main drafters of this section. Song Jinzai, Yaoxiu Jun, Wang red.IntroductionSurgery for bonding living tissue materials and equipment increasingly used for sutures and staples play a supporting role in all kinds of surgery, Or used to replace these devices. Depending on the patient's specific circumstances, the nature and size of the force is also very different. All applications Material involving varying degrees of mechanical force applied affordability. Thus, the mechanical properties and adhesion properties of the material is unique to comment Price organizational suitability important parameters. In addition, given the mechanical properties of the adhesive can be used to evaluate whether the product is consistent in quality control , Which also can be used to evaluate the adhesive prior to use is affected by various surface treatments. Application Category tissue adhesion complex instruments. Even in a given application (surgery), if without analysis of the binder Do not understand the performance alone a T- peel test result is unsuitable for determining the allowable design stresses. Susceptibility test methods given in this section can be used to compare changes or adhesive bonding process to fatigue or the environment, but this ratio We must hold a relatively cautious because of different adhesives for different conditions may show different responses. Tissue adhesive bonding performance test method Part 2. T- peel strength tensile carrier1 ScopeYY/T test method specified in this part of the organization for 0729 is expected to be bonded tissue adhesive or sealant on the soft tissue Adhesive strength provide comparable means. The method of selecting suitable substrate, this section can be used in the manufacture of tissue adhesive in quality control.2 Normative referencesThe following documents contain provisions which, through reference YY/T 0729 and become part of the provisions of this section. For dated references, All subsequent amendments (not including errata content) or revisions do not apply to this section, however, encourage the agreement on this section Whether the parties can study the latest versions of these documents. For undated reference documents, the latest versions apply to this section. Inspection and correction tension and (or) pressure testing machine force measuring system. GB/T 16825.1 of static uniaxial testing machines - Part 1 Associate (GB/T 16825.1-2008, ISO 7500-1.1999, IDT)3 Terms and DefinitionsThe following terms and definitions apply YY/T 0729 to the present section. 3.1 The method used in this section indicates that the term should be adhered such a size and physical properties, their adhesion to any corner less than 90 ° No cracking or rupture of the opening. 3.2 This section refers to the expected tissue adhesives for closing wounds (surgery or trauma) or body fluid sealing compound or system leak. 3.3 In order to prevent leakage of body fluids having a suitable surface coating agent adhesive strength. 3.4 Under the conditions specified in this section, the gradual separation of the average load per unit width required for two specimens flexibility of being bonded.4 Instrument4.1 Testing Machine 4.1.1 fixing mechanism, with a fixed or stationary chuck mechanism. 4.1.2 moving mechanism, with the other movable chuck mechanism. 4.1.3 chuck to be sandwiched between the sample testing machine fixing mechanism and moving mechanism may be stationary, but also self-adjusting type. 4.1.3.1 Fixed chuck. rigid fixing mechanism and moving mechanism connected to the tester, when using this type of chuck, should pay special attention To ensure that the sample is inserted, and ensure the long axis of the sample by stretching direction coincides with the centerline of the collet assembly when clamped. 4.1.3.2 Automatic centering chuck. fixed mechanism and the moving mechanism in such a way to connect to the test machine, that is, once a load is applied, two Who would free the pair, so that the long axis of the sample with the tensile direction by the collet assembly centerline consistent. 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