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标题: 說明書紙質檔還是電子檔 [打印本页]

作者: andyyoung 时间: 2015-11-26 12:10
标题: 說明書紙質檔還是電子檔
產品說明書的問題，安全部份說明書，產品整機銷售的不搭配紙質檔的，供用戶網上下載，只提供電子檔的。申請認證都是提供電子檔的給認證機構，他們審核沒問題就可以了，并不關注是紙質的還是電子的。請教大俠們，是否有其他規定明確規定必須是隨整機銷售的紙質檔？

作者: lxxcumt 时间: 2015-11-26 13:10
本帖最后由 lxxcumt 于 2015-11-26 13:20 编辑

IEC 60065-1
5.5 Instructions
5.5.1 When information with regard to safety is required according to this standard, this
information shall be given in an instruction for installation or use and supplied with the
apparatus. This information shall be given in a language acceptable to the country where the apparatus is intended to be used.
IEC 60601-1
7.9 ACCOMPANYING DOCUMENTS
7.9.1 * General (see also Table C.4)
ME EQUIPMENT shall be accompanied by documents containing at least the instructions for use
and a technical description. The ACCOMPANYING DOCUMENTS shall be regarded as a part of the
ME EQUIPMENT.
NOTE The purpose of the ACCOMPANYING DOCUMENTS is to promote the safe use of the ME EQUIPMENT during its
EXPECTED SERVICE LIFE.
IEC 60335-1
7.12 Instructions for use shall be provided with the appliance so that the appliance can be used safely.
NOTE Instructions for use may be marked on the appliance as long as they are visible in normal use.

以上标准没规定必须是纸质的，但是必须随机提供。

作者: martin_cheng 时间: 2015-11-26 13:15
可以是纸质的，也可以是电子的（例如附带的光盘、说明书download网址信息等）。

作者: andyyoung 时间: 2015-11-26 14:46

lxxcumt 发表于 2015-11-26 13:10
IEC 60065-1
5.5 Instructions
5.5.1 When information with regard to safety is required according to ...

Thanks !

作者: wildorange 时间: 2016-2-23 10:20
还需要查法规。很多标签的要求不是标准里规定的，而是市场准入的法规或指导文件里要求的。如欧盟的医疗器械指令的指导文件就对电子版的说明书提出了明确要求。

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