Personal Protective Equipment (PPE) Testing

The Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and World Health Organization (WHO) have recently updated their guidelines to ensure Personal Protective Equiptment (PPE) can get to market faster. By issuing new guidance on testing and production for hand sanitizers, medical and consumer masks, medical gowns, and face shields, companies outside of the regularly licensed producers are now helping fill the unprecedented need for PPE.

元件has developed solutions to perform and/or coordinate the required testing for PPE, hand sanitizers, masks, gowns, and face shields, to ASTM F2100, USP 611, and ANSI Z87 standards to help you achieve the certification necessary to get these critical products into the hands of those who need them.

Hand Sanitizer Testing

Following the CDC and World Health Organization’s policy, all hand sanitizers in production are required to undergo USP 611 Method II: Alcohol Determination performed by GC-FID before they can be released to the market.

元素通过GC-FID为每USP 611提供醇测定测试，以验证产物中至少70％异丙醇（IPA）或60％乙醇。我们的GC-FID方法是USP 611下允许的方法中最精确和成本效益，因为它允许直接分析样品矩阵。这种直接分析允许我们的专家量化产品中存在的乙醇或IPA，而无需广泛的样品制备，降低了您的测试成本，同时提供了更精确的结果。

元素还提供酒精确定测试GC-MSto identify any additional compounds that may be present in the product and could be harmful to users.

Our Santa Fe Springs Pharma laboratory can also provide testing of ethanol and isopropyl alcohol against the USP monograph specifications as raw materials intended for use in the manufacturing of hand sanitizer products under US FDA guidelines.

我们在需要的酒精内容识别测试时提供快速的服务。

医疗和消费者面膜测试

根据FDA指南，在分布使用之前，需要每种ASTM F2100方法进行医疗面罩进行测试。测试还需要考虑测试方法的预期用途和适用性，以获得所需的监管提交。消费者掩码只需要方法9.5，但是，高度鼓励方法9.2和9.3来验证面膜效率。

元件is one of the few testing laboratories that can facilitate all five methods. Our experts can guide you through the process and provide one complete testing report for medical masks.

• 方法9.1 - ASTM F2101 - 细菌过滤
• 方法9.2 - EN 14683：2019 - 差压
• 方法9.3 - ASTM F2299 - 颗粒过滤
• Method 9.4 – ASTM F1962 – Synthetic Blood
• Method 9.5 – 16 CFR Part 1610 -易燃

While N95 masks are traditionally single-use, the unprecedented shortage has resulted in decontamination efforts to re-use these devices. Element can perform residual hydrogen peroxide testing on new masks to ensure that the client procedure for decontamination does not leave behind residual H2O2.

Face Shield Testing

根据美国国家标准研究所（ANSI）指导方针，所有面罩必须对ISEA Z87.1-2020进行测试，以确保在释放市场之前预防眼睛和面部受伤的安全性和有效性。

元素通过规范的六个关键部分，以确保面罩在医疗环境中的有效性。这些部分包括：

• 第5.2.4节 - 最低覆盖区
• 9.2节,透光率
• Section 9.3 – Haze
• Section 9.6 – Drop Ball
• Section 9.7 – Ignition
• Section 9.17.2 – Droplet and Splash

医疗纺织测试

Building and Fire Codes require all fabrics and films, including medical gowns, to undergoflame propagation testingbefore they can be released to the market. Because textiles and films provide a conduit for flame spread, they can be significant contributors to the growth of building fires. Assessing their flammability characteristics is crucial to understand whether a fire is likely to start and how the flame will develop.

In addition to assessing flammability characteristics per ASTM F2100 Method 9.5, CAN/ULC-S109, and NFPA 701 Methods 1 and 2, our experts perform water resistance, tensile strength, seam strength, link generation, evaporative resistance, colorfastness, fabric durability, and more to help textile suppliers ensure their medical materials and gowns comply with required safety standards.

有关隔离和外科礼服的测试要求的更多信息，请下载我们的免费指南。

The Element Advantage

Element的专业专家团队在各种测试服务中有多年的经验medical device和产品认证yabo官网入口industries to help you meet regulations and ensure that every aspect of your product is properly tested.

For more information on personal protective equipment (PPE) testing,请立即联系我们.