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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 04 listopada 2024. Database contains 4821 unique substances/entries.
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404-200-2
110488-70-5
Repr. 1B
432-310-0
617-55-0
Flam. Liq. 3; Eye Dam. 1; Skin Sens. 1
C.I. DISPERSE BLUE 356
400-460-6
118578-14-6
Skin Sens. 1
620-379-1
3254-63-5
Acute Tox. 1; Acute Tox. 2
210-478-4
616-38-6
Flam. Liq. 2
210-871-0
624-92-0
Flam. Liq. 2; Acute Tox. 3; STOT SE 3; STOT SE 1; Eye Irrit. 2; Skin Sens. 1
204-065-8
115-10-6
Flam. Gas 1; Press. Gas
432-860-1
255387-46-3
Skin Sens. 1
201-208-6
79-44-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-901-0
75-78-5
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-508-2
107-64-2
Eye Dam. 1
SUMQUAT 6040
404-050-8
123312-54-9
Eye Irrit. 2
301-323-2
93983-68-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
209-805-3
593-74-8
Acute Tox. 2; Acute Tox. 1; STOT RE 2
200-549-8
62-75-9
Carc. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
236-412-4
13360-57-1
Carc. 1B; Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
212-039-2
753-73-1
Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Skin Corr. 1B
208-884-1
544-97-8
Pyr. Liq. 1; Water-react. 1; 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
617-485-5
76714-88-0
Acute Tox. 4
246-673-6
25154-54-5
Acute Tox. 2; Acute Tox. 1; STOT RE 2
234-126-4
10544-72-6
Press. Gas; Ox. Gas 1; Acute Tox. 2; Skin Corr. 1B
247-096-2
25550-58-7
Acute Tox. 3; STOT RE 2
246-836-1
25321-14-6
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
213-546-1
973-21-7
Acute Tox. 3
254-408-0
39300-45-3
Repr. 1B; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
-
63919-26-6
Acute Tox. 4
620-422-4
4097-36-3
Acute Tox. 3
215-813-8
1420-07-1
Repr. 1B; Acute Tox. 2; Acute Tox. 3
222-883-3
3648-18-8
Repr. 1B; STOT RE 1
293-901-5
91648-39-4
Repr. 1B; STOT RE 1
223-292-3
3811-49-2
Acute Tox. 3; STOT SE 1
230-253-4
6988-21-2
Acute Tox. 3
201-107-7
78-34-2
Acute Tox. 2; Acute Tox. 3
-
-
P Parasites
201-434-5
82-66-6
Acute Tox. 2; STOT RE 1
213-482-4
957-51-7
Acute Tox. 4
427-300-8
79463-77-7
Eye Dam. 1
251-084-2
32534-81-9
STOT RE 2; Lact.
278-355-8
75980-60-8
Repr. 2
CYRACURE (R) PHOTOINITIATOR UVI-6974; CYRACURE PHOTOINITIATOR UVI-6976
403-500-0
159120-95-3
Skin Sens. 1

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