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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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210-338-2
613-35-4
Carc. 1B; Muta. 2; Acute Tox. 4
262-661-3
61213-25-0
Repr. 1B; Acute Tox. 4; Skin Sens. 1
210-322-5
612-82-8
Carc. 1B; Acute Tox. 4
210-313-6
612-52-2
Carc. 1A; Acute Tox. 4
210-260-9
611-21-2
Acute Tox. 3; STOT RE 2
210-256-7
611-15-4
Acute Tox. 4
210-222-1
610-39-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
200-521-5
61-82-5
Repr. 2; STOT RE 2
-
60999-18-0
Acute Tox. 3; STOT RE 2
228-042-7
6094-40-2
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
210-199-8
609-72-3
Acute Tox. 3; STOT RE 2
210-187-2
609-26-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
4-BROM-2-CHLORFLUORBENZOL; 4-BROMO-2-CHLOROFLUOROBENZENE
405-580-2
60811-21-4
Acute Tox. 4; Skin Irrit. 2
210-172-0
608-93-5
Flam. Sol. 1; Acute Tox. 4
210-168-9
608-73-1
Carc. 2; Acute Tox. 3; Acute Tox. 4
414-920-9
60658-04-0
Acute Tox. 3; STOT RE 1; Skin Sens. 1
620-419-8
606-35-9
Expl. 1.1; Acute Tox. 4
210-106-0
606-20-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
262-302-0
60568-05-0
Carc. 2
227-964-7
6053-68-5
Eye Irrit. 2; STOT SE 3
210-088-4
605-50-5
Repr. 1B
yes
434-630-6
60372-77-2
Eye Dam. 1
262-104-4
60207-90-1
Repr. 1B; Acute Tox. 4; Skin Sens. 1
262-102-3
60207-31-0
Acute Tox. 4
210-027-1
602-99-3
Expl. 1.1; Acute Tox. 4
210-025-0
602-87-9
Carc. 1B
210-013-5
602-01-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
262-095-7
60168-88-9
Repr. 2; Lact.
209-990-0
600-25-9
Acute Tox. 4
200-484-5
60-57-1
Carc. 2; Acute Tox. 1; Acute Tox. 3; STOT RE 1
200-480-3
60-51-5
Acute Tox. 4
200-473-5
60-35-5
Carc. 2
200-471-4
60-34-4
Carc. 1B
200-467-2
60-29-7
Flam. Liq. 1; Acute Tox. 4; STOT SE 3
200-453-6
60-09-3
Carc. 1B
yes
200-449-4
60-00-4
Eye Irrit. 2
227-815-6
5989-54-8
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
227-813-5
5989-27-5
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1B; Asp. Tox. 1
209-952-3
598-78-7
Acute Tox. 4; Skin Corr. 1A
209-940-8
598-56-1
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B
TEPIC-H
423-400-0
59653-74-6
Muta. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
yes
FT-310; PF-310
407-400-8
59493-72-0
Eye Dam. 1
209-855-6
594-82-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-854-0
594-72-9
Acute Tox. 3
A5546
402-050-2
59337-93-8
Skin Sens. 1
CHLORGELB; HC YELLOW 12
413-280-8
59320-13-7
Acute Tox. 4
227-678-2
5932-68-3
Skin Sens. 1A
209-805-3
593-74-8
Acute Tox. 2; Acute Tox. 1; STOT RE 2
209-800-6
593-60-2
Press. Gas; Flam. Gas 1; Carc. 1B
N-N-OCTYLCAPROLACTAM; N-OCTYLCAPROLACTAME
420-040-6
59227-88-2
Skin Corr. 1B; Skin Sens. 1

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