Regulatory agencies worldwide have set stringent performance standards for nearly every category of medical device. Today, bringing a new medical device to market requires in-depth knowledge of all of its characteristics, from properties of the raw materials to long-term performance under what can be complex service conditions. The medical device testing required to meet the wide variety of standards spans nearly every type of mechanical test including tension, compression, impact, fatigue, and hardness. For single-use products, testing is particularly important during material selection to maximize the trade-off between performance and cost. There are a wide variety of applications, including needles, syringes, tubing, and packaging.
Syringes and Needles
- General Syringe Testing
- Plunger Force for Needles and Syringes
- Needle Insertion Force Measurement: Multi-Needle Test Fixture
- Tensile Testing of Hypodermic Needles
- Sterile Hypodermic Syringes for Single Use: Part 1 Annex G: Syringes for Manual Use to ISO 7886-1
- Adhesive Strength of Medical Packaging to ASTM F88
- Seal Strength of Flexible Barrier Materials: Using a 180-degree Peel Test according to ASTM F 88
- Tensile Testing of Thin-Walled Surgical Tubing or Medical Tubing
- Surgical Tubing, Fittings, and Catheters
- Tensile Testing Thin-Walled Surgical Tubing with a Long Travel Extensometer
- Tensile Test of Catheter Tubing
- Tensile Testing of Medical Gloves to ASTM D6319 and ISO 11193
- Physical Properties of Medical Gloves to BS EN 455-2
- Wound Closure Strength of Tissue Adhesives and Sealants to ASTM F2458
- Tensile Testing of Surgical Sutures: Using Straight-Pull and Knot-Pull Tests
Other medical device testing equipment solutions are available, including use of standard test system with universial fixtures, such as an XY Stage or a Tapped Plate. The latest equipment for testing of medical devices includes the BioBox, a 37 °C chamber for simulating body temperature, and the BioCoat, a liquid-resistant cover for a single-column testing machine.
Testing systems that can be used for implantable medical devices include the 3340 and 3360 Series, 5940 and 5960 Series and ElectroPuls™ dynamic test instruments. Other testing systems such as torsion, multi-axial and impact can also be used.