YY/T 0729.4-2009 Test methods for bonding properties of tissue adhesives - Part 4: Wound closure strength
1 Scope
This part of YY/T 0729 covers a means for comparison of wound closure strength of tissue adhesives used to help secure the apposition of soft tissue. With the appropriate choice of substrate, this part may also be used for purposes of quality control in the manufacture of medical devices used as tissue adhesives.
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
any material used as a medical device to help secure the apposition of two wound edges or opposed soft tissues
3.2
tissue sealant
a surface coating with adequate adhesive strength to prevent leakage of body fluids
3.3
cohesive strength
internal strength of the adhesive
3.4
adhesive strength
strength of the tissue adhesive/substrate interface
3.5
cohesive failure
failure of the internal adhesive bond
3.6
adhesive failure
failure of the adhesive/substrate bond
3.7
substrate failure
failure of the tissue substrate
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. Gripping pressure should be adjustable to prevent damage to the substrate and the use of sandpaper or plastic scrubbing pads between the gripping surfaces and the substrate is recommended to help prevent slippage.
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
