EO Testing involves the identification of EO components in products. The method used to determine the EO content depends on the type of product and its intended use. Generally, two methods are used in residual EO analysis: exhaustive extraction and simulated-use extraction. Exhaustive extraction is the most common method. Both methods are effective for detecting the presence of EO.

Exhaustive extraction

The purpose of exhaustive extraction testing is to evaluate a pharmaceutical's biocompatibility and subacute toxicity. The procedure requires that several IOL samples are taken from a single lot or collection of lots. Depending on the type of lens, exhaustive extraction may be necessary for different IOLs. Several endpoints must be assessed, including spectral transmission, surface and bulk homogeneity, compression force, dynamic fatigue, and sensitivity to ozone.

A 510(k) clearance application for a new electrode technology was submitted to the FDA in November 2021. However, the FDA denied the 510(k) clearance because of its analysis of the methodology used inexhaustive extraction testing. The agency stated that using the device for less than 30 days is not substantially equivalent to using it for prolonged periods.

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Simulated-use extraction

Simulated-use extraction is a technique used in EO testing to estimate the level of exposure in a patient. It involves preparing the product for testing and following pre-use instructions on the label. The extraction process must also be performed according to the sponsor's specifications. There are two types of extraction methods: exhaustive extraction and simulated-use extraction.

The solvent used in the simulated-use extraction is methanol, which is a common solvent for EO. However, different solvents have different properties. Hence, adding a different solvent to the sample changes its properties. In this study, the methanol used was added to the extract of devices and materials. The materials were also extracted using cell culture media containing 10% FBS. The resulting residual EO concentrations were determined by international standards.

Gimbals

Gimbals for EO testing are a versatile tool that helps companies meet regulatory requirements and save time and money. This technology has a variety of advantages over traditional methods of testing and is suitable for both high-speed operations and high-volume manufacturing. Direct-drive gimbals are an excellent choice for EO testing, and they can provide high-precision angular measurements.

Direct-drive gimbals use motors that are directly connected to the rotation axes. This eliminates the need for gearboxes or mechanical couplings. Direct-drive gimbals offer high precision, high dynamics and reliability without mechanical wear or friction.

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Robots

EO testing for robots helps to assess the reliability of a robot and to avoid unplanned downtime. Robot reliability is vital because customers depend on it to operate seamlessly and without any interruptions. EO testing helps to determine a robot's failure rate and part lifespan, allowing the manufacturer to plan maintenance and production cycles accordingly. It also helps to ensure operational deadlines are met.

In EO testing for robots, one side of the robot is positioned in an environment where humans can easily interact with it. In the case of an EO sensor, one-sided gimbals can be used to test its azimuth and roll. Gimbals are also a good choice for testing tracking sensors and missile seeker systems.