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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 20 rujna 2024. Database contains 4821 unique substances/entries.
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284-032-2
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84777-06-0
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Repr. 1B |
yes |
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272-013-1
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68648-93-1
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yes |
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276-158-1
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71888-89-6
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Repr. 1B |
yes |
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271-084-6
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68515-42-4
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Repr. 1B |
yes |
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220-120-9
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2634-33-5
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Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1 |
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203-977-3
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112-49-2
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Repr. 1B |
yes |
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202-479-3
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96-12-8
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Carc. 1B; Muta. 1B; Repr. 1A; Acute Tox. 3; STOT RE 2 |
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203-444-5
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106-93-4
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Carc. 1B; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2 |
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202-425-9
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95-50-1
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Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2 |
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203-458-1
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107-06-2
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Flam. Liq. 2; Carc. 1B; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2 |
yes |
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