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医用面罩 EN 166 防护面罩 隔离面罩CE认证

关键词:防护面罩

详细信息

  防护面罩、隔离面罩、医用面罩等是以来非常重要的防护装置,可有效保护面部和颈部免受液体飞溅、飞沫传播、病毒隔离等,CE认证标准:

  EN 166 : 2002 Personal eye-protection — Specifications个人眼睛防护 - 规范

  防护面罩-隔离面罩CE认证-

  防护面罩只属于PPE II类产品,需要欧盟公告号机构Notified Body进行Module B 形式检验,颁发B证书。那么在申请CE认证的过程中,防护面罩需要满足哪些要求呢? 下面由认证工程师为您解读。

  Basic, particular and optional requirements. 防护面罩CE认证基本、特殊和可选要求

  所有防护面罩都要满足基本要求。

  此外,根据其预期用途,应满足对应的一项或多项特殊要求。

  可选要求制造企业可自行选择。

  Basic requirements 基本要求

  1.1 Field of vision

  The size of the field of vision is defined in conjunction with the appropriate head-form described in clause 17 of EN 168:2001.

  视野大小的定义与EN 168:2001第17条中描述的适当头型相结合。

  Eye-protectors shall exhibit a minimum field of vision defined by the two ellipses in Figure 1 when placed and centered at a distance of 25 mm from the surface of the eyes of the appropriate head-form. The horizontal axis shall be parallel to and 0,7 mm below the height of the line connecting the centres of the two eyes.

  当将护眼器放置在距离适当头型眼睛表面25mm的中心位置时,应显示如图1中两个椭圆所定义的最小视野。横轴应平行于连接两眼中心的线的高度0.7毫米以下。

  The horizontal length of the ellipses shall be of 22,0 mm, the vertical width of the ellipses shall be 20,0 mm. The centre distance of the two ellipses shall be d =c + 6 mm, where c is the pupillary distance. The pupillary distance is 64 mm for the medium head-form and 54 mm for the small head-form, if not specified differently by the manufacture.

  椭圆的水平长度应为22.0毫米,垂直宽度应为20.0毫米。两个椭圆的中心距离应为d =c + 6mm,其中c为瞳孔距离。瞳孔距离为64毫米为中等头部形式和54毫米为小头部形式,如果没有不同的制造商。

  The test shall be carried out in accordance with clause 18 of EN 168:2001.

  测试应按照EN 168:2001条款18进行。

  防护面罩视野要求-CE认证

  1.2 Optical requirements光学要求

  1.2.1 Spherical, astigmatic and prismatic refractive powers球面、像散和棱镜折射率

  The refractive powers of oculars shall be measured by the reference methods specified in clause 3 of EN 1 67:2001. This clause refers also to an optional method for use in specific circumstances; the details of this method are given in annex A of EN 1 67:2001. 应采用EN 1 67:2001第3条规定的参考方法测量眼睛的屈光力。本条款还提及了在特定情况下使用的可选方法;EN 1 67:2001附录A中给出了该方法的详细信息

  1.2.1.1 Unmounted oculars covering one eye覆盖一只眼睛的未安装眼镜

  The refractive power characteristics of unmounted oculars covering one eye shall be measured by the method specified in 3.1 of EN 1 67:2001 (non-corrective oculars), and by the methods specified in EN ISO 8980-3 (corrective oculars).

  The permissible tolerances for oculars without corrective effect are given in Table 2.

  The permissible deviations for the vertex powers of oculars with corrective effect are specified in EN ISO 8980-1 and EN ISO 8980-2. Oculars that comply with EN ISO 8980-1 and EN ISO 8980-2 shall be categorized as class 1.

  For class 2, the deviations in vertex refractions may be 0,06 m -1 higher than for class 1.

  应采用EN 1 67:2001(非矫正视力)3.1中规定的方法和EN ISO 8980-3(矫正视力)中规定的方法测量覆盖一只眼睛的未安装视力的屈光力特性。

  表2给出了无矫正效果的眼的容许公差。

  EN ISO 8980-1和EN ISO 8980-2中规定了具有矫正效果的目镜顶点功率的允许偏差。符合EN ISO 8980-1和EN ISO 8980-2的眼睛应归类为1级。

  对于2类,顶点折射的偏差可能比1类高0.06 m-1。

  1.2.1.2 Mounted oculars and unmounted oculars covering both eyes安装的目镜和未安装的目镜覆盖双眼

  The refractive power characteristics of mounted oculars or unmounted oculars covering both eyes shall be measured by the method specified in 3.2 of EN 1 67:2001 at the visual center of the ocular. The permissible tolerances for oculars without corrective effect are given in Table 3. The permissible deviations for vertex powers of oculars with corrective effect are as defined in 7.1 .2.1 .1 . Deviations that would correspond to class 3 shall not be permitted.

  NOTE The difference in prismatic refractive power specified for an eye-protector depends not only on the prismatic refractive power of each ocular, but also on the position of the optical axis of the ocular in relation to the axis of vision, and therefore the shape of the frame. It is therefore necessary to use replacement oculars for which the difference in prismatic power remains within the permissible tolerance limits for the frame in question.

  应采用EN 1 67:2001中3.2规定的方法,在眼睛的视觉中心测量覆盖双眼的已安装或未安装眼镜的屈光力特性。表3给出了无矫正效果的眼的容许公差。7.1中定义了具有矫正效果的眼睛顶点功率的允许偏差。2.1 .1.不允许出现与3级相对应的偏差。

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