YY/T 0729.1-2009 Test methods for bonding properties of tissue adhesives - Part 1: Strength in lap-shear by tension loading
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 7500-1:2004, 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
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3.3
strength in lap-shear by tension loading
average load per unit bonded area required to produce progressive separation of two adherends, under conditions designated in this part, expressed in megapascals (MPa)
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.
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 porcine skin graft
