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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 12 srpnja 2024. Database contains 4821 unique substances/entries.
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204-801-8
126-75-0
Acute Tox. 1; Acute Tox. 2
212-758-1
867-27-6
Acute Tox. 3
206-053-8
298-03-3
Acute Tox. 1; Acute Tox. 2
620-378-6
8065-48-3
Acute Tox. 1; Acute Tox. 2
219-971-9
2587-90-8
Acute Tox. 2; Acute Tox. 3
211-666-9
682-80-4
Acute Tox. 2; Acute Tox. 3
258-256-6
52918-63-5
Acute Tox. 3
-
1563-67-3
Acute Tox. 3
206-376-4
334-48-5
Skin Irrit. 2; Eye Irrit. 2
208-764-9
541-02-6
yes
200-024-3
50-29-3
Carc. 2; Acute Tox. 3; STOT RE 1
208-576-7
533-74-4
Acute Tox. 4; Eye Irrit. 2
201-248-4
80-08-0
Acute Tox. 4
200-923-0
75-99-0
Skin Irrit. 2; Eye Dam. 1
204-828-5
127-20-8
Skin Irrit. 2; Eye Dam. 1
432-960-5
124655-09-0
Acute Tox. 4
218-827-2
2244-16-8
Skin Sens. 1
DEM
408-120-9
65197-96-8
Acute Tox. 4; Eye Dam. 1
-
-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
274-050-9
69581-33-5
Acute Tox. 3; Acute Tox. 4
601-785-8
121552-61-2
Skin Sens. 1
619-020-1
94361-06-5
Repr. 1B; Acute Tox. 3; STOT RE 2
257-842-9
52315-07-8
Acute Tox. 4; STOT SE 3; STOT RE 2
257-842-9
52315-07-8
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
261-043-0
57966-95-7
Repr. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1
236-049-1
13121-70-5
Acute Tox. 4
269-855-7
68359-37-5
Acute Tox. 2; Acute Tox. 3
269-855-7
68359-37-5
Acute Tox. 2
642-974-5
400882-07-7
Carc. 2; Skin Sens. 1A
405-230-9
101205-02-1
Repr. 2
-
-
P Parasites
200-847-8
75-19-4
Flam. Gas 1; Press. Gas
CHLOROFORMIATE DE CYCLOPENTYLE; CYCLOPENTYLCHLORFORMIAT
411-460-0
50715-28-1
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
428-340-9
238088-70-5
Skin Irrit. 2
204-435-9
120-92-3
Flam. Liq. 3; Eye Irrit. 2; Skin Irrit. 2
227-964-7
6053-68-5
Eye Irrit. 2; STOT SE 3
206-016-6
287-92-3
Flam. Liq. 2
VIOLIFF
401-620-8
87731-18-8
Skin Sens. 1
220-279-4
2699-11-8
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
220-279-4
2699-11-8
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
CHMMS; CHMS; DYNASYLAN 9407; Z-6187
402-140-1
17865-32-6
Skin Irrit. 2
203-629-0
108-91-8
Flam. Liq. 3; Repr. 2; Acute Tox. 4; Skin Corr. 1B
221-319-3
3066-71-5
STOT SE 3; Skin Irrit. 2
200-636-0
66-81-9
Muta. 2; Repr. 1B; Acute Tox. 2
235-527-7
12262-58-7
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
235-527-7
12262-58-7
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
203-631-1
108-94-1
Flam. Liq. 3; Acute Tox. 4
203-630-6
108-93-0
Acute Tox. 4; STOT SE 3; Skin Irrit. 2
201-604-9
85-42-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
203-806-2
110-82-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3

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