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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 svibnja 2024. Database contains 4821 unique substances/entries.
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203-560-6
108-20-3
Flam. Liq. 2; STOT SE 3
203-558-5
108-18-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B
203-326-3
105-74-8
Org. Perox. D
REACTIVE ORANGE F-64 258 FW
401-010-1
106027-83-2
Skin Sens. 1
BLUE GS 1259 R5
407-230-4
126637-70-5
Acute Tox. 4; Skin Sens. 1
204-076-8
115-26-4
Acute Tox. 1; Acute Tox. 2
233-307-5
10112-91-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
215-629-8
1335-31-5
Expl. 1.1; Acute Tox. 3; STOT RE 2
605-329-9
163515-14-8
Acute Tox. 4; Skin Sens. 1
404-200-2
110488-70-5
Repr. 1B
C.I. DISPERSE BLUE 356
400-460-6
118578-14-6
Skin Sens. 1
204-065-8
115-10-6
Flam. Gas 1; Press. Gas
203-508-2
107-64-2
Eye Dam. 1
SUMQUAT 6040
404-050-8
123312-54-9
Eye Irrit. 2
236-412-4
13360-57-1
Carc. 1B; Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
215-993-8
1468-37-7
Acute Tox. 4
604-712-8
149961-52-4
Carc. 2; Repr. 2; Acute Tox. 4
205-042-5
131-89-5
Acute Tox. 3
234-494-6
12007-01-1
Carc. 1A; STOT RE 1; Skin Sens. 1
238-426-6
14448-18-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
238-946-3
14874-78-3
Carc. 1A; STOT RE 1; Skin Sens. 1
237-411-1
13775-54-7
Carc. 1A; STOT RE 1; Skin Sens. 1
234-828-0
12035-64-2
Carc. 1A; STOT RE 1; Skin Sens. 1
235-033-1
12059-14-2
Carc. 1A; STOT RE 1; Skin Sens. 1
215-217-8
1314-06-3
Carc. 1A; STOT RE 1; Skin Sens. 1
234-126-4
10544-72-6
Press. Gas; Ox. Gas 1; Acute Tox. 2; Skin Corr. 1B
215-813-8
1420-07-1
Repr. 1B; Acute Tox. 2; Acute Tox. 3
235-702-8
12578-12-0
yes
CYRACURE (R) PHOTOINITIATOR UVI-6974; CYRACURE PHOTOINITIATOR UVI-6976
403-500-0
159120-95-3
Skin Sens. 1
204-539-4
122-39-4
Acute Tox. 3; STOT RE 2
-
19372-20-4
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
215-242-4
1314-80-3
Flam. Sol. 1; Water-react. 1; Acute Tox. 4
240-979-3
16921-30-5
Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
215-197-0
1312-73-8
Skin Corr. 1B
233-050-9
10025-99-7
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
203-869-6
111-43-3
Flam. Liq. 2; STOT SE 3
205-565-9
142-84-7
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
SÄUREBRAUN 8507
404-930-1
118556-91-5
Acute Tox. 4; Eye Dam. 1
427-310-2
180850-95-7
Eye Dam. 1
REACTIVE BLUE FC 60866
414-040-5
149530-93-8
Acute Tox. 4; Skin Sens. 1
217-710-3
1937-37-7
Carc. 1B; Repr. 2
yes
YELLOW DO 2286
412-530-3
157627-98-0
Eye Dam. 1; Skin Sens. 1
EVERZOL ORANGE GR; ORANGE HF-SNK; REAKTIV ORANGE FD 19969 FW
404-600-7
129009-88-7
Skin Sens. 1
SCARLET X-GA 1491
410-390-8
147703-64-8
Eye Dam. 1
240-983-5
16923-58-3
Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
234-541-0
12008-41-2
Repr. 1B
yes
602-894-3
12280-03-4
Repr. 1B
215-211-5
1313-82-2
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
603-411-9
1303-96-4
Repr. 1B
yes
601-808-1
12179-04-3
Repr. 1B
yes

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