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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 21 lipnja 2024. Database contains 4821 unique substances/entries.
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201-114-5
78-40-0
Acute Tox. 4
TRIETHYLARSENAT; TRIETHYLARSENATE; TRIETHYLARSENATE (TEASAT)
427-700-2
15606-95-8
Carc. 1A; Acute Tox. 3
yes
DYNASILAN BH N; DYNASILAN BSM 100 N; DYNASILAN NH 42
402-810-3
17980-47-1
Skin Irrit. 2
246-347-3
24602-86-6
Repr. 1B; Acute Tox. 4; Skin Irrit. 2
274-462-9
70225-16-0
yes
255-559-5
41814-78-2
Acute Tox. 4
215-548-8
1330-78-5
STOT SE 1
215-548-8
1330-78-5
Acute Tox. 4
206-203-2
307-55-1
yes
222-182-2
3380-34-5
Eye Irrit. 2; Skin Irrit. 2
-
-
P Parasites
-
-
F Fungi
-
-
F Fungi
233-042-5
10025-78-2
Flam. Liq. 1; Pyr. Liq. 1; Acute Tox. 4; Skin Corr. 1A
200-930-9
76-06-2
Acute Tox. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
206-326-1
327-98-0
Acute Tox. 2; Acute Tox. 3
213-608-8
993-16-8
Repr. 2
201-167-4
79-01-6
Carc. 1B; Muta. 2; Eye Irrit. 2; Skin Irrit. 2; STOT SE 3
yes
208-885-7
545-06-2
Acute Tox. 3
200-902-6
75-79-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-149-3
52-68-6
Acute Tox. 4; Skin Sens. 1
-
-
P Parasites
-
-
Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Irrit. 2; Eye Irrit. 2
D 27-046
413-520-1
125792-14-5
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
204-800-2
126-73-8
Carc. 2; Acute Tox. 4; Skin Irrit. 2

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