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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 12 srpnja 2024. Database contains 4821 unique substances/entries.
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200-026-4
50-31-7
Acute Tox. 4
MR-7 B; MR-8 B2; MR-S2
411-290-7
131538-00-6
Acute Tox. 4; STOT RE 2
202-480-9
96-13-9
Carc. 1B; Repr. 2; Acute Tox. 3; Acute Tox. 4
yes
DCTFMP
410-340-5
69045-84-7
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
201-153-8
78-88-6
Flam. Liq. 2; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
424-060-6
6364-17-6
Acute Tox. 4; STOT RE 2; Skin Sens. 1
201-193-6
79-29-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-547-1
584-94-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-280-0
565-59-3
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
200-628-7
66-56-8
Acute Tox. 3; STOT RE 2

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