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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 11 rujna 2024. Database contains 4821 unique substances/entries.
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201-091-1
78-18-2
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
201-091-1
78-18-2
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
201-084-3
78-11-5
Unst. Expl.
201-084-3
78-11-5
Expl. 1.1
201-083-8
78-10-4
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
201-075-4
78-00-2
yes
Z-22
415-880-5
779343-34-9
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
232-245-6
7791-25-5
Skin Corr. 1B; STOT SE 3
232-235-1
7790-98-9
Expl. 1.1; Ox. Sol. 1
232-234-6
7790-94-5
Skin Corr. 1A; STOT SE 3
616-572-5
7790-84-3
yes
232-223-6
7790-80-9
Acute Tox. 3; Carc. 2; STOT RE 2
232-222-0
7790-79-6
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
yes
640-998-0
7790-78-5
yes
232-189-2
7789-78-8
Water-react. 1
232-178-2
7789-60-8
Skin Corr. 1B; STOT SE 3
232-156-2
7789-29-9
Acute Tox. 3; Skin Corr. 1B
232-151-5
7789-23-3
Acute Tox. 3
232-149-4
7789-21-1
Acute Tox. 4; Skin Corr. 1A
616-541-6
7789-12-0
yes
232-143-1
7789-09-5
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
232-142-6
7789-06-2
Carc. 1B; Acute Tox. 4
yes
232-140-5
7789-00-6
Carc. 1B; Muta. 1B; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
yes
232-104-9
7786-81-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
232-095-1
7786-34-7
Acute Tox. 1; Acute Tox. 2

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