YY/T 0729.3-2009 Test methods for bonding properties of tissue adhesives - Part 3: Tension strength
1 Scope
The test methods specified in this part of YY/T 0729 are intended to provide a means for comparison of the adhesive strengths of tissue adhesives intended for use as surgical adhesives or sealants, or both, on soft tissue. With the appropriate choice of substrate, this part may also be used for purposes of quality control in the manufacture of tissue adhesive.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of YY/T 0729. For dated references, subsequent amendments to (excluding correction to), or revisions of, any of these publications do not apply. However, parties to agreements based on this part are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. For undated references, the latest edition of the normative document applies.
GB/T 16825.1 Verification of static uniaxial testing machines - Part 1: Tension/compression testing machines - Verification and calibration of the force-measuring system (GB/T 16825.1-2008, ISO 7500-1:1999, IDT)
3 Terms and definitions
For the purposes of this part of YY/T 0729, the following terms and definitions apply.
3.1
tissue adhesive
for the purposes of this part, tissue adhesive is defined as a compound or system intended for use in closing wounds (surgical or traumatic) or for sealing against leakage of body fluids
3.2
tissue sealant
a surface coating with adequate adhesive strength to prevent leakage of body fluids
4 Apparatus
4.1 Testing machine
4.1.1 Fixed member, a fixed or essentially stationary member carrying one grip.
4.1.2 Movable member, a movable member carrying a second grip.
4.1.3 Grips, for holding the test specimen between the fixed member and the movable member of the testing machine, can be either the fixed or self-aligning type.
4.1.3.1 Fixed grips are rigidly attached to the fixed and movable members of the testing machine. When this type of grip is used, extreme care should be taken to ensure that the test specimen is inserted and clamped so that the long axis of the test specimen coincides with the direction of pull through the centerline of the grip assembly.
4.1.3.2 Self-aligning grips are attached to the fixed and movable members of the testing machine in such a manner that they will move freely into alignment as soon as any load is applied so that the long axis of the test specimen will coincide with the direction of the applied pull through the centerline of the grip assembly. The specimens should be aligned as perfectly as possible with the direction of pull so that no rotary motion that may induce slippage or damage to the sample will occur in the grips; there is a limit to the amount of misalignment self-aligning grips will accommodate.
4.1.4 Drive mechanism, for imparting to the movable member a uniform, controlled velocity, with this velocity to be regulated as specified in 8.3.
4.1.5 Load indicator, a suitable load-indicating mechanism capable of showing the total tensile load carried by the test specimen when held by the grips. This mechanism shall be essentially free of inertia lag at the specified rate of testing and shall indicate the load with an accuracy of ±1% of the indicated value, or better. The accuracy of the testing machine shall be verified and calibrated in accordance with GB/T 16825.1.
4.2 Temperature-controlling equipment
Foreword I
Introduction II
1 Scope
2 Normative references
3 Terms and definitions
4 Apparatus
5 Test substrate
6 Test specimen
7 Sample preparation
8 Test procedure
9 Calculations
10 Report
Annex A (Normative) Rationale for test temperature used for comparative testing
Annex B (Informative) Procedure for preparation of fresh split thickness porcine skin graft
YY/T 0729.3-2009 Test methods for bonding properties of tissue adhesives - Part 3: Tension strength
1 Scope
The test methods specified in this part of YY/T 0729 are intended to provide a means for comparison of the adhesive strengths of tissue adhesives intended for use as surgical adhesives or sealants, or both, on soft tissue. With the appropriate choice of substrate, this part may also be used for purposes of quality control in the manufacture of tissue adhesive.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this part of YY/T 0729. For dated references, subsequent amendments to (excluding correction to), or revisions of, any of these publications do not apply. However, parties to agreements based on this part are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. For undated references, the latest edition of the normative document applies.
GB/T 16825.1 Verification of static uniaxial testing machines - Part 1: Tension/compression testing machines - Verification and calibration of the force-measuring system (GB/T 16825.1-2008, ISO 7500-1:1999, IDT)
3 Terms and definitions
For the purposes of this part of YY/T 0729, the following terms and definitions apply.
3.1
tissue adhesive
for the purposes of this part, tissue adhesive is defined as a compound or system intended for use in closing wounds (surgical or traumatic) or for sealing against leakage of body fluids
3.2
tissue sealant
a surface coating with adequate adhesive strength to prevent leakage of body fluids
4 Apparatus
4.1 Testing machine
4.1.1 Fixed member, a fixed or essentially stationary member carrying one grip.
4.1.2 Movable member, a movable member carrying a second grip.
4.1.3 Grips, for holding the test specimen between the fixed member and the movable member of the testing machine, can be either the fixed or self-aligning type.
4.1.3.1 Fixed grips are rigidly attached to the fixed and movable members of the testing machine. When this type of grip is used, extreme care should be taken to ensure that the test specimen is inserted and clamped so that the long axis of the test specimen coincides with the direction of pull through the centerline of the grip assembly.
4.1.3.2 Self-aligning grips are attached to the fixed and movable members of the testing machine in such a manner that they will move freely into alignment as soon as any load is applied so that the long axis of the test specimen will coincide with the direction of the applied pull through the centerline of the grip assembly. The specimens should be aligned as perfectly as possible with the direction of pull so that no rotary motion that may induce slippage or damage to the sample will occur in the grips; there is a limit to the amount of misalignment self-aligning grips will accommodate.
4.1.4 Drive mechanism, for imparting to the movable member a uniform, controlled velocity, with this velocity to be regulated as specified in 8.3.
4.1.5 Load indicator, a suitable load-indicating mechanism capable of showing the total tensile load carried by the test specimen when held by the grips. This mechanism shall be essentially free of inertia lag at the specified rate of testing and shall indicate the load with an accuracy of ±1% of the indicated value, or better. The accuracy of the testing machine shall be verified and calibrated in accordance with GB/T 16825.1.
4.2 Temperature-controlling equipment
Contents of YY/T 0729.3-2009
Foreword I
Introduction II
1 Scope
2 Normative references
3 Terms and definitions
4 Apparatus
5 Test substrate
6 Test specimen
7 Sample preparation
8 Test procedure
9 Calculations
10 Report
Annex A (Normative) Rationale for test temperature used for comparative testing
Annex B (Informative) Procedure for preparation of fresh split thickness porcine skin graft
