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YY/T 0729.1-2009 English PDF

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YY/T 0729.1-2009: Test methods for boning properties of tissue adhesives. Part 1: Strength in lap-shear by tension loading
Status: Valid
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YY/T 0729.1-2009279 Add to Cart 3 days Test methods for boning properties of tissue adhesives. Part 1: Strength in lap-shear by tension loading Valid

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Basic data

Standard ID: YY/T 0729.1-2009 (YY/T0729.1-2009)
Description (Translated English): Test methods for boning properties of tissue adhesives. Part 1: Strength in lap-shear 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: 12,147
Date of Issue: 2009-06-16
Date of Implementation: 2010-12-01
Quoted Standard: GB/T 16825.1
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 tissue adhesive in the manufacture of quality control.

YY/T 0729.1-2009: Test methods for boning properties of tissue adhesives. Part 1: Strength in lap-shear 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 boning properties of tissue adhesives.Part 1. Strength in lap-shear by tension loading ICS 11.120.20 C48 People's Republic of China pharmaceutical industry standards Tissue adhesive bonding performance test method Part 1. Lap - bearing shear tensile strength Posted 2009-06-16 2010-12-01 implementation State Food and Drug Administration issued

Foreword

YY/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 10729 of. The partial modification using ASTM F2255-05 "tissue adhesive lap - shear strength Standard Test Method for Tensile bearer", and ASTMF2255-05 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, Wang red, Yaoxiu Jun.

Introduction

Surgery 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 lap shear 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 1. Lap - bearing shear tensile strength

1 Scope

YY/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 part can be used for tissue adhesives manufacturing quality control.

2 Normative references

The 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 7500-1.2004, IDT)

3 Terms and Definitions

The following terms and definitions apply YY/T 0729 to the present section. 3.1 This section refers to the expected tissue adhesives for closing wounds (surgery or trauma) or body fluid leaks or plugging compound system. 3.2 In order to prevent leakage of body fluids having a suitable surface coating agent adhesive strength. 3.3 Under the conditions specified in this section, measured per unit of gradual separation of the desired bonding area when the two adherends bonded Average Load in MPa units.

4 Instrument

4.1 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 Style. 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. in such a way that the fixing mechanism and the moving mechanism connected to the tester, that is, once a load is applied, Both will be free to the stretching direction passing through the centerline of the collet assembly coincides with the long axis of the specimen. The sample may be implemented in the tensile direction
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