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<h2><strong>What Are Ethylene Oxide (EtO) Residuals?</strong></h2>
<p><em>Ethylene oxide residuals</em> are:</p>
<ul>
<li><strong>Ethylene oxide (EO or EtO)</strong></li>
<li><strong>Ethylene chlorohydrin (ECH)</strong></li>
<li><strong>Ethylene glycol (EG)</strong></li>
</ul>
<p>These residual compounds are hazardous to both people and the environment. Ethylene glycol is formed from the reaction of ethylene oxide and water, while ethylene chlorohydrin is formed from the interaction of ethylene oxide and chloride compounds.</p>
<h2><strong>What Is Ethylene Oxide Residual Testing, And Why Is It Needed?</strong></h2>
<p>products sterilized with ethylene oxide must meet strict ethylene oxide residual limits to ensure patient safety during medical device and product use. Current ISO 10993-7 EtO residual limits .</p>
<h2><strong>What Products Require Ethylene Oxide Residuals Testing?</strong></h2>
<p>&nbsp;If your device or product does not come into physical contact with the patient, there is no need to perform EtO residual testing.</p>
<h2><strong>How Is Ethylene Oxide Residual Testing Performed?</strong></h2>
<p>When determining the amount and type of EtO residuals in a medical device, two different methods are used for EtO residual analysis: simulated-use extraction and exhaustive extraction. Evaluation via both testing methods is not necessary - either method is sufficient to meet the ISO 10993-7 standards for EtO residual testing.</p>
<ul>
<li><strong>Simulated-Use Extraction</strong>: Simulates exposure of a patient to the fraction of the EtO sterilized device that the patient would interact with during normal product use.</li>
<li><strong>Exhaustive Extraction</strong>: Estimates the majority of EtO residual that a patient would be exposed to during device use.</li>
</ul>
<h2><strong>Allowable Limit Calculations</strong></h2>
<p>Allowable limit (AL) is the largest acceptable exposure from a particular toxin, such as ethylene oxide. AL is expressed in units of milligrams per day and is the product of tolerable exposure (TE) and a benefit factor (BF). TE is the product of TI, body mass (BW), and utilization factor (UTF).</p>
<p>As there is generally no significant health benefit resulting from the use of an EtO-sterilized device, the BF is set at 1. Thus, the allowable limit for EtO residuals is equal to the tolerable exposure.</p>
<p>Current EtO &amp; ECH Allowable Limits Are:</p>
<ul>
<li>4 mg/d of EO and 9 mg/d of ECH for limited exposure (first 24 hours)</li>
<li>0 mg/d of EO and 2 mg/d of ECH for prolonged exposure (1-30 days)</li>
<li>1 mg/d of EO and 0.4 mg/d of ECH for prolonged exposure (more than 30 days)</li>
</ul>
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<h4 class="elementor-heading-title elementor-size-default">Allowable Limit Equation:</h4>
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<p><strong>AL =&nbsp;</strong>TE x BF</p>
<p><strong>Where:</strong></p>
<p><strong>TE</strong>&nbsp;= tolerable exposure</p>
<p><strong>BF</strong>= benefit factor</p>
<p><strong>And:</strong></p>
<p><strong>TE</strong>&nbsp;= TI x BW x UTF</p>
<p><strong>Where:</strong></p>
<p><strong>TI</strong>&nbsp;= tolerable intake (mg/kg/d)</p>
<p><strong>BW</strong>&nbsp;= body weight (kilograms (kg))</p>
<p><strong>UTF&nbsp;</strong>= utilization factor</p>
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How To Calculate Allowable Limits For Ethylene Oxide Sterilization

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What Are Ethylene Oxide (EtO) Residuals Ethylene oxide residuals are:  Ethylene oxide  Ethylene chlorohydrin Ethylene glycol 

How To Calculate Allowable Limits For Ethylene Oxide Sterilization

Publish Time：2023-12-11