太阳眼镜EN IS标准测试
FDA Drop Ball Test (FDA 落球测试)Requirements
FDA Drop Ball Test落球测试必须遵循哪些要求
落球测试
落球测试是测试镜片抗冲击能力的测试。
耐冲击性是美国眼镜或镜片的基本标准。
太阳镜FDA Drop Ball Test (FDA 落球测试) Requirements
FDA 落球测试必须遵循以下要求：
1.冲击测试将包括一个重量约为0.56盎司的5/8英寸钢珠
2.球应从距镜头水平上表面50英寸高处落下
3. 镜头的几何中心应为在直径5/8英寸的圆圈内击球
4.不能有任何限制球落下的东西
5.可以使用管子将球引导到镜头; 球可以通过延伸到透镜大约4英寸内的管落下.
FDA Drop Ball Test Requirements
太阳眼镜FDA落球测试
太阳镜FDA落球测试
The Food and Drug Administration (FDA) reviews shipments of sunglasses and lenses to check for proper documentation. FDA requires shipments of glasses and/or lenses include the “Drop Ball Test” certificate with it.
The FDA regulates eye wear products to ensure their safety. Impact resistance is an essential criterion for U.S. bound glasses and/or lenses. The FDA does not explicitly define a number of lenses that need to be tested before approved; it depends on the size of the shipment and the material/type of lens. However, the FDA does state that the drop ball test must be performed on every glass lens for prescription use.
There is a guidance document for the drop ball test. The regulation states the following requirements:
1. The impact test will consist of a 5/8 inch steel ball weighing approximately 0.56 ounces
2. The ball should be dropped from a height of 50 inches from the horizontal upper surface of the lens
3. The geometric center of the lens should be struck by the ball within a 5/8 inch diameter circle
4. There cannot be anything restricting the fall of the ball
5. A tube may be used to guide the ball to the lens; the ball may be dropped through a tube extending to within approximately 4 inches of the lens
Title 21 of the FDA’s Code of Federal Regulations states that the lens cannot fracture on impact in order to pass the test. A lens is considered fractured if:
1. It cracks through its entire thickness, including a laminar layer, if any, and across a complete diameter into two or more separate pieces; or
2. Any lens material visible to the naked eye becomes detached from the ocular surface (i.e., the surface of the lens that is closest to the eye when the lens is in actual use).
A failure to include the “Drop Ball” certificate with your shipment can result in a delay in your shipment by the FDA. To avoid any delays make sure the Drop Ball Test results are attached to your shipping documents.
根据欧盟关于太阳眼镜的决议，2015年2月28日之前，符合原欧盟标准EN 1836的太阳眼镜在仍可继续在欧盟，挪威，冰岛和列支敦士登境内销售，同时符合新标准EN IS的太阳眼镜亦可销售。自2015年3月1日起，在上述市场销售的所有太阳眼镜都必须符合新标准EN IS
新标准EN ISO 12312最初设定的过渡期少于6个月，预期对2014年春季和夏季进入上述市场的太阳眼镜进行监管。然而欧盟委员会在收到众多利益相关者的请求后，进行了细致的磋商，于欧盟公报上公布了这一决议。
该决议将太阳眼镜新标准EN IS的过渡期延长一年，即过渡期的最后期限从2014年2月28日延长至2015年2月28日，在过渡期内，符合原标准EN+A1:2007或者新标准EN IS5的太阳眼镜均可认定其符合个人防护设备（PPE）指令89/686/EEC中的基本健康和安全要求。该决议缓解了利益相关者根据新标准进行测试和更改标签的压力。·
防护面罩CE认证EN1731测试、
3D眼镜EN379检测，
防护眼镜CE认证EN166测试，
太阳眼镜CE认证EN1836测试、
滑雪眼镜CE认证EN174测试、
越野镜CE认证EN1938测试、
老花镜CE认证、EN14139测试
近视眼镜CE认证、
光学眼镜CE认证、
眼镜片CE认证、
眼镜架CE认证
EN166普通防护眼镜
EN174滑雪下坡使用的护目镜
EN175电焊过程中的眼部与面部防护设备
EN208激光或者激光系统调节工作的眼镜防护设备
EN379自动的电焊过滤器
EN1731防护面罩
EN1836太阳眼镜和一般用途的太阳光过滤镜以及直接观察太阳的过滤镜
EN1938摩托车和机动脚踏车使用者的护目镜
EN13178雪球使用者的眼部防护，
老花镜CE认证，
EN ISO12870 眼镜架CE认证，EN IS眼镜片CE认证
医疗器械FDA注册
