EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10
EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10
Medical Devices Regulation - Hazardous Substances
EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020
This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the non-exhaustive database is derived from: Table 3 of Annex VI to CLP, REACH Candidate List of SVHCs, and Directive 2000/54/EC's Annex III (Biological Agents list).
Last updated 26 srpnja 2024. Database contains 4917 unique substances/entries.
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P Parasites |
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P Parasites |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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215-604-1
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1333-73-9
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R Toxic for reproduction (article 57c) |
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25747-83-5
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R Toxic for reproduction (article 57c) |
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14890-53-0
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R Toxic for reproduction (article 57c) |
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22454-04-2
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R Toxic for reproduction (article 57c) |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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125022-34-6
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R Toxic for reproduction (article 57c) |
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90568-23-3
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R Toxic for reproduction (article 57c) |
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F Fungi |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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200-268-0
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56-35-9
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PBT Persistent, Bioaccumulative and Toxic (article 57d) |
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214-604-9
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1163-19-5
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PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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201-247-9
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80-07-9
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VPVB very Persistent and very Bioaccumulative (article 57e) |
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VPVB very Persistent and very Bioaccumulative (article 57e) |
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247-426-5
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26040-51-7
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VPVB very Persistent and very Bioaccumulative (article 57e) |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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603-802-4
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134237-51-7
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PBT Persistent, Bioaccumulative and Toxic (article 57d) |
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205-883-8
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191-24-2
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PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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B Bacteria and similar species |
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B Bacteria and similar species |
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B Bacteria and similar species |
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P Parasites |
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B Bacteria and similar species |
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B Bacteria and similar species |
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P Parasites |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans. |
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F Fungi |
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231-901-9
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7778-39-4
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C Carcinogenic (article 57a) |
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B Bacteria and similar species |
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204-371-1
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120-12-7
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PBT Persistent, Bioaccumulative and Toxic (article 57d) |
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P Parasites |
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