ASTM F2193 encompasses varied test annexes to perform determining the strength, stiffness, and durability of spinal screws.
ADMET’s eXpert 2600 will perfom the following tests:
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
ASTM F2193 encompasses varied test annexes to perform determining the strength, stiffness, and durability of spinal screws.
ADMET’s eXpert 2600 will perfom the following tests:
ASTM F2502 is a standard for testing Bioabsorbable Plates and Screws for Internal Fixation Implants.
These types of plates and screws are resorbed into the body once implanted to unstable bone or tissue connected to bone. The advantage over a metallic fixation device is that a bioabsorbable device does not need to be removed. The challenge to medical device manufacturers of bioabsorbable devices is to ensure full healing takes place before the bioabsorbable device is fully deteriorated.
There are four Annexes describing the testing procedures to follow in this specification.
Spinal Implants and Intervertebral Fusion Devices are tested according to several ASTM standards. ASTM F2267 is intended to provide a basis for the mechanical comparison among past, present and future non-biologic intervertebral body fusion devices. These, sometimes hollow, devices are inserted to promote arthrodesis(fusion) at a given spinal motion segment. Construct are governed by ASTM F1717.
Shear joints impose uniform stresses across the bond area which results in the highest possible joint strength. ASTM D1002 is commonly performed to measure the shear strength of adhesives that are used to bond metals. This test is similar to ASTM D3163 which is for adhesives that bond rigid plastic substrates, and also ASTM D3164 which is for plastic adhesives that are used to bond both plastic and metal substrates. All three of these specifications use a single lap joint (lap shear) specimen to
determine the shear strength of adhesives. If you are going to perform this test, you should read the entire specification from ASTM.
In the ASTM acceptance standard for testing rubber surgical gloves (D3577) and rubber medical gloves (D3578), made of latex, vinyl, and nitrile. The standard describes the standard size, material properties, physical and mechanical property acceptance levels, aqueous protein and antigen protein content, and visual inspection required for a glove to be used in a medical procedure. Other relevant standards include ASTM D6319, ASTM D5250, EN 455-2, ISO 11193-1:2002, and ISO/AWI 11193-2.
Constitutive models are necessary to predict the mechanical behavior of biological tissues. However, biological materials present challenges in constitutive modeling due to their complex mechanical behavior. Their oriented fibrous structures often exhibit pronounced mechanical anisotropy. Due to anisotropy, stress strain data generated from uniaxial tests cannot be used to extrapolate to generalized three-dimensional constitutive equations.
ASTM F1264 Annex 3 is a test method for bending fatigue testing of intramedullary fixation devices (IMFD). This cyclic, four-point bend test determines the fatigue life at a specified bending moment or estimates the fatigue strength for a specified number of cycles.
ASTM D412 covers the tensile properties of thermoset rubbers and thermoplastic elastomers. The specification describes two test methods, A and B. Method A is common and can be performed on a universal testing machine (tensile testing machine). If you are going to perform this test, you should read the entire specification from ASTM. This is a quick summary to decide if this test is right for you and to point out what equipment you need to perform the test.
This video shows the basic steps necessary to perform the ASTM D412 test:
A suture is a medical device that doctors use to hold skin, internal organs, blood vessels and all other tissues of the human body together, after they have been severed by injury or surgery. They must be strong enough to hold the tissue and flexible enough to be easily tied into knots.
Suture tensile strength determines where the suture can be used inside or outside of the body and for how long it is intended to remain. Sutures are absorbable or non-absorbable and in some cases, have needles attached.
Below we describe a typical suture tensile test and what type of equipment is needed to perform this test.
Typical points of interest when tensile testing a material include ultimate tensile strength or peak stress; modulus of elasticity, offset yield strength, which represents a point just beyond the onset of permanent deformation; and elongation at break.
The modulus of elasticity is calculated as the slope in the linear elastic region of the stress-strain curve. The linear elastic region is prior to the proportional limit (see point A – Figure 1). Beyond the proportional limit, the material undergoes permanent plastic deformation.