对于附件XIV中仅规定对人类健康有害的物质，是否必须提交受REACH第60(2)条第2款所述行业特定法规监管的医疗器械中该物质的授权申请？此项豁免是否涵盖在制造过程中将附件XIV中的物质加入产品？如果是，那么在将物质加入医疗器械之前的生命周期步骤是否需要授权？

对于附件XIV中仅规定对人类健康有害的物质，是否必须提交受REACH第60(2)条第2款所述行业特定法规监管的医疗器械中该物质的授权申请？此项豁免是否涵盖在制造过程中将附件XIV中的物质加入产品？如果是，那么在将物质加入医疗器械之前的生命周期步骤是否需要授权？

Does an application for authorisation for the use of a substance in a medical device regulated by the sector-specific legislation referred to in Article 60(2) 2nd subparagraph of REACH have to be submitted for a substance for which Annex XIV specifies human health hazards only? Does this exemption cover the incorporation of the Annex XIV substance into the product during the manufacturing process? If so, are the life-cycle steps preceding the incorporation of the substance in the medical device subject to authorisation?

根据 REACH 法规第 60(2) 条和第 62(6) 条，对于根据 90/385/EEC、93/42/EEC 或 98/79/EC 指令监管的医疗器械中使用的物质，如果该物质已被附件 XIV 确定仅用于人类健康，则无需申请授权。在这种情况下，对于在制造过程中将该物质加入医疗器械，或在最终使用之前的上游过程中使用该物质及其相应体积，也无需申请授权。

Pursuant to Articles 60(2) and 62(6) of REACH, an application for authorisation is not required for a substance used in a medical device regulated under Directives 90/385/EEC, 93/42/EEC or 98/79/EC if that substance has been identified in Annex XIV for human health concerns only.   Nor is an application required in such cases for the incorporation of the substance into the medical device during the manufacturing process or for the uses and corresponding volumes of that substance upstream preceding the end-use.