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Syringe testing provides information about the performance of syringes to determine if they match regulatory and internal quality control standards. This can be performed at the facility of a manufacturer, or under contract by a third party. Manufacturers may prefer to use a materials testing facility for accuracy and reliability. Such facilities specialize in evaluating materials prior to sale, and also have a reduced bias factor, because they are paid regardless of the outcome of the testing.
Regulatory standards set out specifications for syringes, including the materials that can be used in their manufacture and their baseline level of performance. In syringe testing, technicians can check for issues like susceptibility to corrosion, stiffness, and breakage. They place syringes under strain and determine when and how they break. Before a company can sell a new syringe product, it may need to provide test results to regulators, and it can also use syringe testing for quality control.
Other topics of interest can include Luer lock connections, used on some syringes to create a non-leaking seal between a syringe and a needle or tubing. These also need to meet standards and must function reliably in regular operations. Companies may also be interested to know how much force is needed to push fluids out or syringes or pull them in. Testing of this nature may require using needles of different sizes to see how they impact syringe performance. Companies may also use syringe testing to evaluate products like preloaded syringes, used to package vaccines and some common medications.
In the course of syringe testing, technicians can develop technical specifications to describe performance. These can determine whether a syringe meets standards set by the government for these medical devices. If it does not, the company may need to change the design to address the issue. The specifications are also important for care providers, as they may have an impact on syringe and needle selection. For example, a nurse preparing to inject a thick suspension wants to make sure to choose the right syringe and needle to reduce pain for the patient.
The outcome of the testing may be available in public filings with regulatory agencies if it comprised part of an application for permission to sell a specific syringe or line of products. In other cases, it may be proprietary and not available to the public, although the company could offer some information about technical specifications on the packaging and in promotional materials. Care providers with specific questions and concerns can contact manufacturers to get more information about their products.
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