EU-IN_VITRO_MEDICAL_DEVICE_REG-ART_5_2_ANX_1
EU-IN_VITRO_MEDICAL_DEVICE_REG-ART_5_2_ANX_1
In Vitro Diagnostic Medical Devices Regulation - Hazardous Substances
EU. Hazardous Substances for Purposes of Art. 5(2) and Annex I of Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices, 5 May 2017, as corrected 27 December 2019
This list contains a non-exhaustive inventory of hazardous substances for purposes of Regulation (EU) 2017/746, including Chap. 2 (Placing on the market and putting into service) and Annex I (General Safety and Performance Requirements). 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).
Last updated 03 toukokuuta 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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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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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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34492-97-2
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Carc. 1A; STOT RE 1; Skin Sens. 1 |
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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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Acute Tox. 4 |
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C Carcinogenic (article 57a) M Mutagen (article 57b) HH2 Specific target organ toxicity after repeated exposure (Article 57(f) - human health) |
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Expl. |
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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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F Fungi |
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F Fungi |
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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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Resp. Sens. 1 |
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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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B Bacteria and similar species |
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Acute Tox. 3; STOT RE 2 |
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Acute Tox. 2; Acute Tox. 1; STOT RE 2 |
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Carc. 1B; Skin Sens. 1 |
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F Fungi |
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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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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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Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2 |
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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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68583-16-4
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B Bacteria and similar species |
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B Bacteria and similar species |
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572-48-5
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Acute Tox. 3 |
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