ASTM D6319 ISO 11193 Medical Gloves, Tensile Testing

Medical gloves can be manufactured from materials such as latex, nitrile and vinyl; all of which must adhere to performance levels specified by the FDA, as well as international standards including ASTM D6319, ASTM D5250, EN 455-2, ISO 11193-1:2002, and ISO/AWI 11193-2. In order to ensure that cross-contamination of the examiner and the patient does not occur, you need to evaluate the aging effects of the material. Testing should examine the strength and elongation of the material at break to ensure that measured values fall within normal ranges of use. We find that the main testing difficulty usually involves measuring strain, since traditional strain measurement devises risk damaging the material, causing unwanted failures at the attachment points.

Our solution is to use our high-resolution, non-contacting video extensometer that precisely measures elongation without extraneous loads or knife-edges to distort results. In addition, we suggest using pnuematic grips for gripping your delicate specimen without tearing or causing slippage. These grips allow for adjustable gripping pressure and a choice of face dimensions and surfaces, such as rubber-coated, serrated, wave-profile or flat metallic.

Records management compliance with FDA 21 CFR § 11 is non-negotiable for many Medical Device and Pharmaceutical companies. ComplianceBuilder™ (CB) is a stand-alone, add-on compliance solution that can be integrated with Instron's Software^®Bluehill, providing features necessary to meet the latest FDA 21 CFR § 11 regulations.