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Mach LED 120F/120
Hazardous Substance Table & Technical Explanation Template
Table of hazardous substances' name and concentration.
部件 名称
Component Name
Mach LED 120F / 120
O: 表示该有毒有害物质在该部件所有均质材料中的含量均在SJ/T11363-2006 标准规定的限量要求以下
X: 表示该有毒有害物质至少在该部件的某一均质材料中的含量超出SJ/T11363-2006 标准规定的限量要求
• 此表所列数据为发布时所能获得的最佳信息
由于缺少经济上或技术上合理可行的替代物质或方案，此医疗设备运用以上一些有毒有害物质来实现设备的
•
预期临床功能，或给人员或环境提供更好的保护效果
O: Indicates that this toxic or hazardous substance contained in all of the homogeneous
materials for this part is below the limit requirement in SJ/T11363-2006.
X: Indicates that this toxic or hazardous substance contained in at least one of the ho-
mogeneous materials used for this part is above the limit requirement in SJ/T11363-2006.
• Data listed in the table represents best information available at the time of publication
• Applications of hazardous substances in this medical device are required to achieve its
intended clinical uses, and/or to provide better protection to human beings and/or to en-
vironment, due to lack of reasonably (economically or technically) available substitutes.
59090005
Mach LED 120F / 120
产品中有毒有害物质或元素的名称及含量
Hazardous substances' name
铅
汞
镉
(Pb)
(Hg)
(Cd)
X
O
O
Édition 11
有毒有害物质 或元素
六价铬
多溴联苯
(Cr(VI))
(PBB)
O
O
。
24/10/2016 / Bak/We Page 7/24
多溴二苯醚
(PBDE)
O
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