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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 02 května 2024. Database contains 4821 unique substances/entries.
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BMS 208143-01; BTHC
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429-670-6
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105996-54-1
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Eye Dam. 1; Skin Sens. 1 |
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LUPRAGEN VP 9159
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401-660-6
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1000-78-8
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Skin Irrit. 2; Skin Sens. 1 |
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435-010-8
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26157-73-3
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Muta. 2 |
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445-760-8
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Eye Dam. 1; Resp. Sens. 1 |
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429-380-1
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133336-92-2
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Skin Sens. 1 |
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435-860-1
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214417-91-1
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Skin Sens. 1 |
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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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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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SYSTHANE TECHNICAL
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410-400-0
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88671-89-0
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Repr. 2; Acute Tox. 4; Eye Irrit. 2 |
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201-329-4
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81-15-2
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Expl. 1.1; Carc. 2 |
yes |
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201-328-9
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81-14-1
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Carc. 2 |
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248-505-7
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27519-02-4
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Skin Sens. 1B |
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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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205-628-0
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144-41-2
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Acute Tox. 3 |
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239-213-0
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15159-40-7
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Carc. 2; Eye Irrit. 2; Skin Irrit. 2 |
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203-815-1
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110-91-8
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Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B |
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B Bacteria and similar species |
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29873-36-7
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Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2 |
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225-062-8
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4636-83-3
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Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2 |
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7411-47-4
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Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin 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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205-766-1
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150-68-5
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Carc. 2; Acute Tox. 4 |
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429-570-2
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213990-58-0
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Skin Sens. 1 |
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217-129-5
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1746-81-2
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Acute Tox. 4; STOT RE 2 |
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230-042-7
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6923-22-4
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Muta. 2; Acute Tox. 2; Acute Tox. 3 |
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203-083-3
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103-16-2
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Eye Irrit. 2; Skin Sens. 1 |
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2 |
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2 |
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Z-22
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415-880-5
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779343-34-9
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Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1 |
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200-820-0
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74-89-5
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Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1 |
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200-820-0
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74-89-5
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Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B |
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