中文内容由 Google Cloud Translation 自动生成，仅供参考；请以英文原文为准。问答资料来自欧盟化学品管理局（ECHA）官方网站。
答案（中文）
属于指令 90/385/EEC 和 93/42/EEC 中定义的医疗器械且为侵入性或用于与人体直接物理接触的物质和混合物，以及指令 98/79/EC 涵盖的物质和混合物，如果处于成品状态并打算供最终用户使用，则总体上不受 CLP 条款的约束： - 指令 90/385/EEC 涵盖的侵入性或用于与人体直接物理接触的物质和混合物包括人工耳蜗、植入式心脏起搏器、植入式除颤器和植入式神经刺激器， - 指令 93/42/EEC 涵盖的侵入性或用于与人体直接物理接触的物质和混合物包括缝合线、导管、支架、球囊导管和伤口敷料，以及 - 指令 98/79/EEC 涵盖的物质和混合物包括试剂用于诊断丙型肝炎和艾滋病毒的仪器、用于测量血糖的自我诊断设备和体外诊断分析仪。由于上述物质和混合物不受CLP规定的约束，因此无需进行分类、包装、贴标和向C&L清单申报。然而，对于每年生产或进口量至少为1吨的物质，无论是单独生产还是包含在混合物中，REACH法规仍可能产生分类义务（但不包括贴标、包装和申报），因为此类物质必须进行注册。
Answer (EN)
Substances and mixtures which are medical devices as defined in Directives 90/385/EEC and 93/42/EEC and which are invasive or used in direct physical contact with the human body, as well as those covered by Directive 98/79/EC, are exempted from the provisions of CLP on the whole if they are in the finished state and intended for the final user:
- Substances and mixtures covered by Directive 90/385/EEC that are invasive or used in direct physical contact with the human body would include cochlear implants, implantable cardiac pacemakers, implantable defibrillators and implantable nerve stimulators,
- Substances and mixtures covered by Directive 93/42/EEC that are invasive or used in direct physical contact with the human body would include sutures, catheters, stents, balloon catheters and wound dressings and
- Substances and mixtures covered by Directive 98/79/EEC would include reagents for diagnostic of Hepatitis C and HIV, self-diagnosis devices for the measurement of blood sugar and IVD Analysers.
As the substances and mixtures mentioned above are exempted from the provisions of CLP, they do not need to be classified, packaged, labelled and notified to the C&L Inventory. However, for substances that are manufactured or imported in volumes of at least 1 tonne per year, either on their own or contained in a mixture, the obligation to classify (but not label, package and notify) may still arise from REACH because such substances would have to be registered.