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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 04 listopada 2024. Database contains 4821 unique substances/entries.
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210-894-6
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625-45-6
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Repr. 1B; Acute Tox. 4; Skin Corr. 1B |
yes |
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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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200-679-5
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68-12-2
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Repr. 1B; Acute Tox. 4; Eye Irrit. 2 |
yes |
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202-959-2
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101-61-1
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Carc. 1B |
yes |
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204-826-4
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127-19-5
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Repr. 1B; Acute Tox. 4 |
yes |
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212-828-1
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872-50-4
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Repr. 1B; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2 |
yes |
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201-182-6
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79-16-3
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Repr. 1B |
yes |
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202-716-0
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98-95-3
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Carc. 2; Repr. 1B; Acute Tox. 3; STOT RE 1 |
yes |
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206-400-3
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335-76-2
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Carc. 2; Repr. 1B; Lact. |
yes |
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246-672-0
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25154-52-3
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Repr. 2; Acute Tox. 4; Skin Corr. 1B |
yes |
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