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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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202-564-5
97-17-6
Acute Tox. 4
214-787-5
1194-65-6
Acute Tox. 4
217-635-6
1918-00-9
Acute Tox. 4; Eye Dam. 1
DBB
401-040-5
75113-37-0
Repr. 1B; Muta. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
201-039-8
77-58-7
Muta. 2; Repr. 1B; STOT RE 1
211-670-0
683-18-1
Muta. 2; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B
yes
245-152-0
22673-19-4
Repr. 1B; STOT RE 1
yes
AMINODARONE OXALATE; SR33580A
448-700-9
500791-70-8
STOT RE 2; Eye Dam. 1; Skin Sens. 1
201-557-4
84-74-2
Repr. 1B
yes
200-824-2
74-95-3
Acute Tox. 4
215-125-8
1303-86-2
Repr. 1B
yes
ZK RT 1507
417-760-8
134164-24-2
STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
202-327-6
94-36-0
Org. Perox. B; Eye Irrit. 2; Skin Sens. 1
205-886-4
191-30-0
Carc. 1B; Muta. 2
205-878-0
189-64-0
Carc. 1B; Muta. 2
200-181-8
53-70-3
Carc. 1B
206-382-7
334-88-3
Carc. 1B
206-373-8
333-41-5
Acute Tox. 4
215-481-4
1327-53-3
Carc. 1A; Acute Tox. 2; Skin Corr. 1B
yes
215-116-9
1303-28-2
Carc. 1A; Acute Tox. 3
yes
237-499-1
13820-41-2
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
231-786-5
7727-54-0
Ox. Sol. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
-
74195-78-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
239-793-5
15699-18-0
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
240-973-0
16919-58-7
Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
422-670-7
150202-11-2
Repr. 2; Acute Tox. 3; STOT RE 2
GENIPLEX A
401-610-3
122012-52-6
Acute Tox. 4; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
234-454-8
12004-35-2
Carc. 1A; STOT RE 1; Skin Sens. 1
205-016-3
131-17-9
Acute Tox. 4
233-689-3
10311-84-9
Acute Tox. 2; Acute Tox. 3
203-733-6
110-05-4
Org. Perox. E; Flam. Liq. 2; Muta. 2
CM 26-137
406-052-4
125078-60-6
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
210-937-9
626-23-3
Flam. Liq. 3; Acute Tox. 4
205-017-9
131-18-0
Repr. 1B
yes
DNOAI
408-190-0
7585-14-0
Pyr. Liq. 1; Skin Corr. 1B
203-921-8
111-92-2
Flam. Liq. 3; Acute Tox. 4
205-575-3
142-96-1
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
204-697-4
124-40-3
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
204-697-4
124-40-3
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
PINOLENE
417-870-6
83648-84-4
Skin Irrit. 2; Skin Sens. 1
686-814-2
34363-01-4
Skin Irrit. 2; Skin Sens. 1
218-961-1
2303-16-4
Carc. 2; Acute Tox. 4
950-299-5
-
yes
DIRECT BLUE 199
416-180-2
12222-04-7
Acute Tox. 4; STOT RE 2
204-424-9
120-78-5
Skin Sens. 1
213-800-1
1014-69-3
Acute Tox. 4
237-198-5
13684-56-5
Repr. 2
-
-
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.
241-109-5
17040-19-6
Acute Tox. 3; Acute Tox. 4
213-052-6
919-86-8
Acute Tox. 3

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