YY/T 0729.4-2009 English PDF

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YY/T 0729.4-2009: Test methods for bonding properties of tissue adhesives. Part 4: Wound closure strength
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0729.4-2009	259	Add to Cart	3 days	Test methods for bonding properties of tissue adhesives. Part 4: Wound closure strength	Valid

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YY/T 0969   YY/T 0866   YY/T 0487   YY/T 0720   YY/T 0729.3   YY/T 0729.1   

Basic data

Standard ID: YY/T 0729.4-2009 (YY/T0729.4-2009)
Description (Translated English): Test methods for bonding properties of tissue adhesives. Part 4: Wound closure strength
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C48
Classification of International Standard: 11.120.040
Word Count Estimation: 11,123
Date of Issue: 2009-06-16
Date of Implementation: 2010-12-01
Quoted Standard: GB/T 16825.1
Adopted Standard: ASTM F2458-2005, MOD
Regulation (derived from): Industry standard filing Notice 2009 No. 9
Issuing agency(ies): State Food and Drug Administration
Summary: This standard provides a comparison used to protect the soft tissue attachment tissue adhesive wound closure strength approach. By selecting suitable substrate, this section can be used for tissue adhesive in the manufacture of medical devices quality control.

YY/T 0729.4-2009: Test methods for bonding properties of tissue adhesives. Part 4: Wound closure 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 4. Wound closure strength ICS 11.120.040 C48 People's Republic of China pharmaceutical industry standards Tissue adhesive bonding performance test method Part 4. wound closure 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 40729 of. The partial modification using ASTMF2458-05 "Standard Test Method for tissue adhesives and sealants wound closure strength", and ASTMF2458-05 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, China Pharmaceutical and Biological Products. The main drafters of this section. Zhang Limei, Feng Xiaoming.

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 their applicability 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 (the procedure itself may vary in different parts of the body And clinical purposes vary), if you do not analyze, do not understand its application, adhesive properties and clinical phenomenon alone a wound closure Strength test results also suitable for determining the allowable design stresses. Test methods may be used in this section gives comparative adhesive bonding process or sensitivity to environmental changes and fatigue, but for this ratio It must be compared with caution, because of different adhesives for different conditions may show different responses. This test method has not been established with the results of actual human living tissue adhesion performance correlation. Tissue adhesive bonding performance test method Part 4. wound closure strength

1 Scope

This section YY/T 0729 include a method for protecting a relatively soft tissue attachment tissue adhesive wound closure strength. through By selecting suitable substrate, this part can be used for tissue adhesive medical device manufacturers in 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 7500-1.1999, IDT)

3 Terms and Definitions

The following terms and definitions apply YY/T 0729 to the present section. 3.1 All use as a medical device to help the wound edges together or soft tissue healing material. 3.2 In order to prevent leakage of body fluids having a suitable surface coating agent adhesive strength. 3.3 Internal adhesive strength. 3.4 Tissue adhesive/substrate interface strength. 3.5 Internal adhesive bonding damage. 3.6 Adhesive/substrate bonding damage. 3.7 Tissue destruction substrate. ......

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