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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269-511-6
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68259-08-5
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VPVB very Persistent and very Bioaccumulative (article 57e) |
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228-098-2
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6130-43-4
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R Toxic for reproduction (article 57c) PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health) E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment) |
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700-242-3
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62037-80-3
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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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604-314-4
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142844-00-6
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C Carcinogenic (article 57a) |
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603-801-9
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134237-50-6
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PBT Persistent, Bioaccumulative and Toxic (article 57d) |
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263-004-3
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61788-76-9
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PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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272-924-4
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68920-70-7
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PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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285-195-2
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85049-26-9
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PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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283-931-7
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84776-07-8
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PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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701-376-5
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1372804-76-6
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PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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287-504-6
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85536-22-7
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PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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283-930-1
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84776-06-7
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PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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307-451-5
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97659-46-6
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PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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281-985-6
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84082-38-2
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PBT Persistent, Bioaccumulative and Toxic (article 57d) VPVB very Persistent and very Bioaccumulative (article 57e) |
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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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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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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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B Bacteria and similar species |
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B Bacteria and similar species |
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257-175-3
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51404-69-4
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R Toxic for reproduction (article 57c) |
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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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273-688-5
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69011-06-9
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R Toxic for reproduction (article 57c) |
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219-943-6
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2580-56-5
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C Carcinogenic (article 57a) |
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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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VPVB very Persistent and very Bioaccumulative (article 57e) |
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621-345-9
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2315-67-5
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ENDE Endocrine disrupting properties (Article 57(f) - environment) |
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1 - 2.5 moles ethoxylated
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500-045-0
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26027-38-3
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ENDE Endocrine disrupting properties (Article 57(f) - environment) |
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1 - 2.5 moles ethoxylated
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500-315-8
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127087-87-0
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ENDE Endocrine disrupting properties (Article 57(f) - environment) |
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ENDE Endocrine disrupting properties (Article 57(f) - environment) |
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ENDE Endocrine disrupting properties (Article 57(f) - environment) |
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202-453-1
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95-80-7
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C Carcinogenic (article 57a) |
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608-055-8
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27147-75-7;27459-10-5
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R Toxic for reproduction (article 57c) ENDE Endocrine disrupting properties (Article 57(f) - environment) END Endocrine disrupting properties (Article 57(f) - human health) |
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608-055-8
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27147-75-7;27459-10-5
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R Toxic for reproduction (article 57c) ENDE Endocrine disrupting properties (Article 57(f) - environment) END Endocrine disrupting properties (Article 57(f) - human health) |
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ENDE Endocrine disrupting properties (Article 57(f) - environment) |
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217-862-0
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1987-50-4
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ENDE Endocrine disrupting properties (Article 57(f) - environment) |
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209-968-0
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599-64-4
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VPVB very Persistent and very Bioaccumulative (article 57e) |
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635-696-0
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186825-39-8
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ENDE Endocrine disrupting properties (Article 57(f) - environment) |
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635-391-2
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142731-63-3
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ENDE Endocrine disrupting properties (Article 57(f) - environment) |
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635-389-1
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186825-36-5
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ENDE Endocrine disrupting properties (Article 57(f) - environment) |
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272-233-8
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68784-25-8
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R Toxic for reproduction (article 57c) ENDE Endocrine disrupting properties (Article 57(f) - environment) END Endocrine disrupting properties (Article 57(f) - human health) |
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R Toxic for reproduction (article 57c) ENDE Endocrine disrupting properties (Article 57(f) - environment) END Endocrine disrupting properties (Article 57(f) - human health) |
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635-388-6
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521947-27-3
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ENDE Endocrine disrupting properties (Article 57(f) - environment) |
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