All facilities in the United States that perform laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease are regulated under the Clinical Laboratory Improvement Amendments of CLIA. Although CLIA requires that waived tests must be simple and have a low risk for erroneous results, this does not mean that waived tests are completely error-proof. Some waived tests have potential for serious health impacts if performed incorrectly. For example, results from waived tests can be used to adjust medication dosages, such as prothrombin time testing in patients undergoing anticoagulant therapy and glucose monitoring in diabetics.
Acceptable Quality Standards in the Leather and Footwear Industry
Don't be Misled by "Latex Free" Claims | FDA
The Joint Commission regularly updates its requirements for accreditation. As part of that process, we seek input from health care professionals and others with knowledge in a variety of settings. You can help by reading and commenting on proposed requirements related to your practice area. Prepublication standards are used to communicate upcoming changes to our standards and Elements of Performance EPs. The reports are posted before being published in E-dition and the comprehensive manuals. For answers to frequently asked questions about standards, please visit the Standards Interpretation section. Background Image: Image: Female doctor talking with her senior patient.
Glove tests are used to evaluate dimensions, tensile strength and elongation, puncture, residual powder, leakage, simulated use, heat aging degradation, and viral barriers. These tests are appropriate for rubber, nitrile, and vinyl materials. Samples are heat aged in an oven.
Natural rubber latex is used in the manufacture of various FDA-regulated products, such as condoms and medical gloves. Here, a physical science technician inspects medical gloves in related integrity testing at an FDA laboratory in Irvine, CA. For this and other FDA photos, go to Flickr.
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