YY/T 0729.3-2009 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 0729.3-2009: Test methods for bonding properties of tissue adhesives. Part 3: Tension strength Status: Valid
Basic dataStandard ID: YY/T 0729.3-2009 (YY/T0729.3-2009)Description (Translated English): Test methods for bonding properties of tissue adhesives. Part 3: Tension strength Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C48 Classification of International Standard: 11.120.20 Word Count Estimation: 11,178 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 the manufacture of tissue adhesive quality control. YY/T 0729.3-2009: Test methods for bonding properties of tissue adhesives. Part 3: Tension strength---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 3. Tension strength ICS 11.120.20 C48 People's Republic of China pharmaceutical industry standards Tissue adhesive bonding performance test method Part 3. Tensile Strength 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 30729 of. The partial modification using ASTMF2258-05 "tissue adhesive tensile strength of standard test methods", and no ASTMF2258-05 Technical differences. 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. Wu Ping, Zhang Limei, Yaoxiu Jun.IntroductionUse, the scope and effectiveness of the binder in many clinical literature has a detailed report. Whether it is used as a binder, a hemostatic agent, secret Sealant, or a pharmaceutical carrier or growth factors, adhesives in the medical field in the increasingly widespread application. There are several factors for the medical organization Critical to the success and effectiveness of the adhesive. They are. 1) appropriate organizational bonding strength; 2) histocompatibility; 3) When used in vivo acceptable biodegradable; 4) accessibility; 5) ease of use; 6) costs. Medical adhesive is widely used in various types of tissue. Applications range from fixed tissue outside the body to be applied to similar Two opposite surfaces or dissimilar. Biological or chemical composition of the binder determines its chemical properties, other mechanical factors, such as the use of an adhesive Or the amount of use will also affect the adhesive properties. Obviously, the amount of medical adhesive strength of the adhesive and the suitability of the adhesive concerned. open Made a constant, reproducible and comparable evaluation standard test method is very important. Since the adhesive is actually used in living tissue, Test is best to use easily-accessible surface of the test organisms. Data generated from a standardized test method may differ from the in vivo situation. However, test results can be valuable for the adhesive properties Information, and to lay the conditions for future in vivo experiments. 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 tensile 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 3. Tensile Strength1 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 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.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 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 The rotational motion of no, it will not slip or damage collet samples, self-adjusting jig can be a small amount of "not for the" conduct adjust. 4.1.4 driving mechanism, according to the provisions of 8.3 at a controlled uniform speed driven moving mechanism. 4.1.5 load indicator, when the sample held in the chuck a load indicating mechanism can display the total sample suffered tensile load. That Agencies, under specified test speed almost no inertia lag, load indication accuracy should not be less than ± 1% of indicated value. The test machine accuracy should be ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0729.3-2009_English be delivered?Answer: Upon your order, we will start to translate YY/T 0729.3-2009_English as soon as possible, and keep you informed of the progress. The lead time is typically 1 ~ 3 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY/T 0729.3-2009_English with my colleagues?Answer: Yes. The purchased PDF of YY/T 0729.3-2009_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay. |
