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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 11 listopada 2024. Database contains 4821 unique substances/entries.
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201-171-6
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79-04-9
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Acute Tox. 3; STOT RE 1; Skin Corr. 1A |
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203-467-0
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107-14-2
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Acute Tox. 3 |
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201-178-4
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79-11-8
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Acute Tox. 3; Skin Corr. 1B |
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203-472-8
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107-20-0
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Carc. 2; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B |
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SEL DE VILSMEIER-HAACK
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425-970-6
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3724-43-4
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Repr. 1B; Acute Tox. 4; Skin Corr. 1A |
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444-950-8
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99464-83-2
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Muta. 2; Skin Sens. 1 |
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SILAN MCS
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410-270-5
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770722-46-8
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Skin Corr. 1A |
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203-480-1
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107-30-2
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Flam. Liq. 2; Carc. 1A; Acute Tox. 4 |
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213-666-4
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999-81-5
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Acute Tox. 4 |
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246-538-1
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24934-91-6
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Acute Tox. 1; Acute Tox. 2 |
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233-162-8
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10049-04-4
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Press. Gas; Ox. Gas 1; Acute Tox. 2; Skin Corr. 1B |
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233-162-8
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10049-04-4
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Acute Tox. 3; Skin Corr. 1B |
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231-959-5
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7782-50-5
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Ox. Gas 1; Press. Gas; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2 |
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216-920-2
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1698-60-8
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Skin Sens. 1 |
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207-432-0
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470-90-6
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Acute Tox. 2; Acute Tox. 3 |
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201-270-4
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80-33-1
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Acute Tox. 4; Skin Irrit. 2 |
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238-413-5
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14437-17-3
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Acute Tox. 4 |
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201-246-3
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80-06-8
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Acute Tox. 4 |
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602-782-4
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122453-73-0
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Acute Tox. 3; Acute Tox. 4 |
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201-599-3
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85-34-7
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Acute Tox. 4 |
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243-269-1
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19750-95-9
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Carc. 2; Acute Tox. 4 |
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228-200-5
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6164-98-3
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Carc. 2; Acute Tox. 4 |
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205-601-3
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143-50-0
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Carc. 2; Acute Tox. 3 |
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200-349-0
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57-74-9
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Carc. 2; Acute Tox. 4 |
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240-016-7
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15879-93-3
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Acute Tox. 4; Acute Tox. 3; STOT SE 3 |
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206-117-5
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302-17-0
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Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2 |
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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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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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618-392-2
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9004-70-0
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Expl. 1.1 |
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Resp. Sens. 1 |
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232-734-4
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9012-54-8
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Resp. Sens. 1 |
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253-465-9
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37329-65-0
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Resp. Sens. 1 |
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202-759-5
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99-49-0
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Skin Sens. 1 |
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239-309-2
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15263-52-2
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Acute Tox. 4 |
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B Bacteria and similar species |
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226-031-1
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5234-68-4
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STOT RE 2; Skin Sens. 1 |
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259-565-9
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55285-14-8
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Acute Tox. 2; Acute Tox. 3; Skin Sens. 1 |
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212-324-1
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786-19-6
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Acute Tox. 3 |
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240-408-8
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16337-84-1
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Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1 |
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200-262-8
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56-23-5
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Carc. 2; Acute Tox. 3; STOT RE 1 |
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211-128-3
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630-08-0
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Flam. Gas 1; Press. Gas; Repr. 1A; Acute Tox. 3; STOT RE 1 |
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200-843-6
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75-15-0
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Flam. Liq. 2; Repr. 2; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2 |
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216-353-0
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1563-66-2
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Acute Tox. 2 |
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240-286-6
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16118-49-3
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Carc. 2; Repr. 1B; Acute Tox. 4 |
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234-232-0
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10605-21-7
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Muta. 1B; Repr. 1B; Skin Sens. 1 |
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200-555-0
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63-25-2
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Carc. 2; Acute Tox. 4 |
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