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YLED-1F
V3
2022-01-19
有害物
质
表格及技
术说
明
Hazardous Substance Table & Technical Explanation Template
YLED-1F
产品中有毒有害物质或元素的名称及含量
Table of hazardous
substances’ name and concentration.
部件
名称
Component Name
有毒有害物质
或元素
Hazardous
substances’ name
铅
(Pb)
汞
(Hg)
镉
(Cd)
六价铬
(Cr(VI))
多溴联苯
(PBB)
多溴二苯醚
(PBDE)
YLED-1F
X
O
O
O
O
O
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 homogeneous 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 environment, due to lack of reasonably (economically or technically)
available substitutes.
