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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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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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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616-584-0
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7803-57-8
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C Carcinogenic (article 57a) |
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P Parasites |
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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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224-208-8
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4247-02-3
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END Endocrine disrupting properties (Article 57(f) - human health) |
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END Endocrine disrupting properties (Article 57(f) - human health) |
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E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment) HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health) |
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234-284-4
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11066-49-2
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ENDE Endocrine disrupting properties (Article 57(f) - environment) |
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609-346-2
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37205-87-1
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ENDE Endocrine disrupting properties (Article 57(f) - environment) |
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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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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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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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237-486-0
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13814-96-5
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R Toxic for reproduction (article 57c) |
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244-073-9
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20837-86-9
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R Toxic for reproduction (article 57c) |
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236-542-1
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13424-46-9
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R Toxic for reproduction (article 57c) |
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233-245-9
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10099-74-8
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R Toxic for reproduction (article 57c) |
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229-335-2
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6477-64-1
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R Toxic for reproduction (article 57c) |
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215-267-0
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1317-36-8
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R Toxic for reproduction (article 57c) |
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234-853-7
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12036-76-9
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R Toxic for reproduction (article 57c) |
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239-290-0
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15245-44-0
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R Toxic for reproduction (article 57c) |
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235-038-9
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12060-00-3
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R Toxic for reproduction (article 57c) |
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235-727-4
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12626-81-2
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R Toxic for reproduction (article 57c) |
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231-100-4
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7439-92-1
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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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P Parasites |
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P Parasites |
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P Parasites |
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P Parasites |
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P Parasites |
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P Parasites |
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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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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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