【爱马斯全球】制造商是…

来源: 时间:2016/10/27 10:09:46

Given the many uses for disposable gloves, they must undergo rigorous inspection before they are ready for sale. In the automotive, janitorial-sanitation and agricultural industries, workers deal with a number of harsh chemicals, which means the gloves they wear must be proven to provide the right amount of protection. The same is true for medical applications, where employees need a safe barrier against pathogens.

由于一次性手套有许多用途,他们在准备出售前必须经过严格的检查。在汽车、清洁卫生和农业行业,工人(会)处理一些刺激性化学物质,这意味着他们戴的手套必须证明(可以)提供适当的保护。医疗应用(手套)也一样,员工需要有一个安全的屏障来抵御病原体。

As such, manufacturers use extensive testing to determine which applications a glove is appropriate for, with medical-grade gloves having higher standards. Here's an overview of the process:

因此,制造商使用广泛的测试,以确定哪一个手套应用是合适的,而医疗级手套就具有更高的标准。以下是过程概述:

Standards for minimum quality

最低质量标准

Glove inspection is based on acceptable quality limits (AQL). For this product, the U.S. Food and Drug Administration sets this standard, and the testing methods for AQL are from the American Society for Testing and Materials (ASTM), a firm that creates standards for various industries across the world.

手套检验是基于抽样标准表(AQL)。对于手套这一产品,美国食品和药品管理局设置了这一标准,而AQL的测试方法源于美国材料与试验协会(ASTM),它是一家为全世界各行各业创建标准的企业。

AQL is a method that applies to batches of gloves and functions as a percentage. For example, in a batch of 100 gloves with an AQL of 3.0, only three gloves in the batch can fail the test. For medical-grade gloves the AQL is 1.5 or lower. If more than three gloves fail, the entire batch does not meet the standard. In this case, manufacturers will review the manufacturing process to determine what requires adjustment.

AQL是适用于批量手套的,它是在百分比中测试手套功能的一个方法。例如,一批100只手套里有3.0的AQL,(说明)只有3只手套在这一批次中被测为不合格。医用手套的AQL(标准)是1.5或更低。如果超过3只手套被检测为不合格,(那么)整个批次(手套产品)就不符合标准。在这种情况下,制造商将审查手套的制造过程,来确定哪一步骤需要调整。

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Given the risks in the medical field, AQL is much lower for medical-grade gloves.

考虑到医疗领域的风险,医疗级手套的AQL值会很低。

Medical-grade gloves have higher AQL standards.

医用手套具有更高的AQL标准。

Testing methods for gloves

手套的测试方法

Glove quality testing involves various inspections. The pinhole leak test, which checks for barrier integrity, is one that determines whether gloves are suitable for medical applications. This is because even the smallest breach in the glove material permits wearers from exposure to pathogens. In this test, manufacturers fill the gloves with one liter of water, close the gloves at the cuff and hang the gloves

upside down. Gloves that do not have leaks during the testing period are acceptable for medical applications.

手套质量测试涉及各种检查。检查(这一防护)屏障完整性的针孔泄漏测试是用来确定手套是否能适合医疗应用的(方式)。这是因为,即使手套材料(存在)极小的破裂,也会使(手套)配戴者接触病原体。在这个测试中,制造商会用一公升水充入手套,封闭手套的袖口,并倒挂手套。在测试期间没有漏(水)的手套,才是适合医用级别的(手套)。

One interesting fact about disposable glove testing and AQL is manufacturers typically produce medical-grade and industrial-grade gloves on the same line. Although industrial-grade gloves also pass standard quality testing by the manufacturer, they are not required to undergo FDA testing for medical purposes.

关于一次性手套AQL(测试方法)的一个有趣事实是,制造商通常在同一生产线生产医用级和工业级手套。虽然工业级手套也通过制造商的标准质量测试,(但)他们不需要接受美国食品和药物管理局的测试。

This is not to say industrial-grade gloves are not of safe quality, but it is simply a cost-efficient way for manufacturers to produce both types of gloves while providing the appropriate level of quality.

这并不是说工业级的手套质量不安全,AQL只是一个具有成本效益的方式。它为制造商同时生产这两种类型的手套提供适当的质量水准。AQL testing sets medical and industrial grade gloves apart.

AQL测试分为医疗手套和工业手套(两种级别)。


 


 


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