EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1
EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1
In Vitro Diagnostic Medical Devices Directive - Hazardous Substances
EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998
This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. It 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). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.
Last updated 12 rujna 2024. Database contains 4821 unique substances/entries.
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621-345-9
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2315-67-5
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yes |
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yes |
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yes |
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yes |
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219-943-6
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2580-56-5
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273-688-5
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69011-06-9
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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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P Parasites |
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257-175-3
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51404-69-4
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yes |
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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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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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yes |
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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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281-985-6
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84082-38-2
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yes |
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307-451-5
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97659-46-6
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yes |
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283-930-1
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84776-06-7
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yes |
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287-504-6
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85536-22-7
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yes |
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701-376-5
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1372804-76-6
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yes |
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283-931-7
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84776-07-8
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yes |
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285-195-2
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85049-26-9
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yes |
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272-924-4
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68920-70-7
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yes |
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263-004-3
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61788-76-9
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yes |
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603-801-9
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134237-50-6
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yes |
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604-314-4
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142844-00-6
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yes |
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700-242-3
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62037-80-3
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yes |
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269-511-6
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68259-08-5
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yes |
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204-371-1
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120-12-7
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yes |
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B Bacteria and similar species |
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P Parasites |
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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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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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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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B Bacteria and similar species |
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