ASTM-F2256 Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading

ASTM-F2256 - 2005 R15 EDITION - CURRENT
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Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading
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Scope

1.1 This test method is 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, it may also be used for purposes of quality control in the manufacture of tissue adhesive based medical devices.

1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Significance and Use

4.1 Materials and devices that function at least in part by adhering to living tissues are finding increasing use in surgical procedures either as adjuncts to sutures and staples, or as frank replacements for those devices in a wide variety of medical procedures. While the nature and magnitude of the forces involved varies greatly with indication and with patient specific circumstances, all uses involve to some extent the ability of the material to resist imposed mechanical forces. Therefore, the mechanical properties of the materials, and in particular the adhesive properties, are important parameters in evaluating their fitness for use. In addition, the mechanical properties of a given adhesive composition can provide a useful means of determining product consistency for quality control, or as a means for determining the effects of various surface treatments on the substrate prior to use of the device.

4.2 The complexity and variety of individual applications for tissue adhesive devices, even within a single indicated use (surgical procedure) is such that the results of a T-Peel test are not suitable for determining allowable design stresses without thorough analysis and understanding of the application and adhesive behaviors.

4.3 This test method may be used for comparing adhesives or bonding processes for susceptibility to fatigue and environmental changes, but such comparisons must be made with great caution since different adhesives may respond differently to varying conditions.

Keywords

adhesive bond; peel test; T-peel; tissue adhesive;; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics); 83.180 (Adhesives)

To find similar documents by ASTM Volume:

13.01 (Medical and Surgical Materials and Devices)

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

83.180 (Adhesives Including adhesive tapes Adhesive tapes for electrical insulation purposes, see 29.035.20)

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Document Number

ASTM-F2256-05(2015)

Revision Level

2005 R15 EDITION

Status

Current

Modification Type

Reapproval

Publication Date

July 1, 2015

Document Type

Test Method

Page Count

5 pages

Committee Number

F04.15