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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 30 svibnja 2024. Database contains 4821 unique substances/entries.
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204-427-5
120-80-9
Carc. 1B; Muta. 2; Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
203-794-9
110-71-4
Flam. Liq. 2; Repr. 1B; Acute Tox. 4
yes
EXPERIMENTAL DIETHER MM; HISOLVE MMPOM
404-630-0
7778-85-0
Flam. Liq. 2
256-152-5
43222-48-6
Acute Tox. 4
PLINYL ACETATE
424-070-0
94346-09-5
Skin Irrit. 2
-
540-73-8
Carc. 1B; Acute Tox. 3
217-101-2
1739-84-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
208-431-8
528-29-0
Acute Tox. 2; Acute Tox. 1; STOT RE 2
203-438-2
106-88-7
Flam. Liq. 2; Carc. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2
202-752-7
99-35-4
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2

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