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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 10 rujna 2024. Database contains 4821 unique substances/entries.
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231-853-9
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7761-88-8
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Ox. Sol. 2; Skin Corr. 1B |
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605-752-9
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175217-20-6
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STOT RE 2 |
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233-054-0
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10026-04-7
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Eye Irrit. 2; STOT SE 3; Skin Irrit. 2 |
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-
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308076-74-6
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Carc. 1B |
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206-991-8
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409-21-2
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Carc. 1B |
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253-461-7
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37321-15-6
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Carc. 1A; STOT RE 1; Skin Sens. 1 |
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-
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37296-97-2
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STOT RE 2 |
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234-363-3
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11120-22-2
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yes |
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-
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68130-19-8
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Carc. 1A; Repr. 1A; STOT RE 1; Skin Sens. 1 |
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272-271-5
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68784-75-8
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yes |
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