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YZB/粤穗
医 疗 器 械 注 册 产 品 标 准
YZB / 粤穗 0102-2012
理疗电极片
2012-09-20 发布 2012-10-15 实施
广 州 市 今 健 医 疗 器 械 有 限 公 司 发布
YZB / 粤穗 0102-2012
目 次
前言 ············································································································· II·
1 范围 ·········································································································1
2 规范性文件 ································································································1
3 分类与标记 ································································································1
4 要求 ·········································································································5
5 试验方法 ···································································································7
6 检验规则 ································································································· 11
7 标志、包装、运输、贮存 ············································································ 12
I
YZB / 粤穗 0102-2012
前 言
本标准是广州市今健医疗器械有限公司生产的理疗电极片的产品注册标准。
本标准按照《医疗器械监督管理条理》 、《医疗器械标准化管理办法》和《医疗器械注
册产品标准编写规范》的规定而编写。
本标准生物性能按 GB/T16886.1-2011 《医疗器械生物学评价 第
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