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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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271-084-6
68515-42-4
Repr. 1B
yes
211-076-1
629-14-1
Flam. Liq. 2; Repr. 1A; Eye Irrit. 2
yes
FAT 92'364/A
411-990-2
68612-94-2
Skin Sens. 1
211-463-5
646-06-0
Flam. Liq. 2
CIB R634
406-220-7
65322-65-8
Carc. 2; Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
BEH; FC-05; FCO5; WMT 1155
417-340-4
65855-02-9
Acute Tox. 4
T-5914 AND 501006025007
421-340-1
6777-05-5
Acute Tox. 4
209-990-0
600-25-9
Acute Tox. 4
211-420-0
644-64-4
Acute Tox. 3; Acute Tox. 4
MEM
418-250-8
65756-41-4
Muta. 2
MEP
418-200-5
69227-51-6
Muta. 2
210-946-8
626-38-0
Flam. Liq. 3
210-484-7
616-47-7
Acute Tox. 4; Skin Corr. 1B
202-706-6
618-36-0;98-84-0
Acute Tox. 4; Skin Corr. 1B
202-706-6
618-36-0;98-84-0
Acute Tox. 4; Skin Corr. 1B
2,2'-AZOBIS(2-METHYL-N-(2-HYDROXYETHYL)PROPIONAMID)
429-090-3
61551-69-7
Skin Sens. 1
229-962-1
6864-37-5
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A
PERMACHEM N21
412-380-9
69094-18-4
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1A; Skin Sens. 1
METHYL ETHYL THIAZOLIDINE
404-500-3
694-64-4
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
2,3,5,6-TETRAFLUROROBENZOIC ACID; SUBSTANCE TFBA
416-800-1
652-18-6
Skin Irrit. 2; Eye Dam. 1
DCTFMP
410-340-5
69045-84-7
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
424-060-6
6364-17-6
Acute Tox. 4; STOT RE 2; Skin Sens. 1
200-628-7
66-56-8
Acute Tox. 3; STOT RE 2
210-013-5
602-01-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
T3P
422-210-5
68957-94-8
Skin Corr. 1B
210-027-1
602-99-3
Expl. 1.1; Acute Tox. 4
211-187-5
632-92-8
Expl. 1.1; Acute Tox. 4; STOT RE 2
620-419-8
606-35-9
Expl. 1.1; Acute Tox. 4
210-406-1
615-05-4
Carc. 1B; Muta. 2; Acute Tox. 4
210-581-4
619-15-8
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
210-106-0
606-20-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
426-480-5
63562-33-4
Skin Sens. 1
425-760-4
64137-52-6
Eye Dam. 1
DPX-D-7556
403-580-7
62096-63-3
Acute Tox. 4
424-520-6
65753-47-1
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
210-885-7
625-29-6
Flam. Liq. 2; Acute Tox. 4
434-270-1
6261-30-9
Skin Irrit. 2; Eye Dam. 1
G.1417
400-290-2
69045-82-5
Flam. Liq. 3; Skin Sens. 1
211-363-1
640-19-7
Acute Tox. 2; Acute Tox. 3
FRESCOLAT MGA
408-200-3
63187-91-7
Skin Irrit. 2; Eye Dam. 1
228-871-4
6369-59-1
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
210-431-8
615-50-9
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
210-843-8
624-41-9
Flam. Liq. 3
211-765-7
693-98-1
Repr. 1B
yes
D(+)-LACTATE D'ISOBUTYLE
407-770-0
61597-96-4
Eye Irrit. 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
DMBC
413-010-9
6613-44-1
Skin Corr. 1B; Skin Sens. 1
210-566-2
618-85-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
427-870-8
6903-18-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
210-467-4
616-20-6
Flam. Liq. 2; Acute Tox. 4
CHLOROFORMIATE DE CHLORO 3 PROPYLE
425-770-9
628-11-5
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
210-187-2
609-26-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
210-621-0
619-99-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
210-529-0
617-78-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
AP-5
401-720-1
6807-17-6
Repr. 1B; Eye Irrit. 2
yes
264-843-8
64359-81-5
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1; Eye Dam. 1; Skin Sens. 1A
272-233-8
68784-25-8
yes
200-453-6
60-09-3
Carc. 1B
yes
4-BROM-2-CHLORFLUORBENZOL; 4-BROMO-2-CHLOROFLUOROBENZENE
405-580-2
60811-21-4
Acute Tox. 4; Skin Irrit. 2
CHLORO ESTER; CHLOROESTER
410-950-1
69788-75-6
Skin Sens. 1
432-560-0
61721-07-1
Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
211-535-6
659-49-4
Acute Tox. 4
HYDRAMETHYLNON
405-090-9
67485-29-4
STOT RE 1; Acute Tox. 4; Eye Irrit. 2
428-410-9
67014-36-2
Acute Tox. 4; Skin Sens. 1
210-025-0
602-87-9
Carc. 1B
RONACAT RO 305; RONACOAT RO 305
404-870-6
63740-41-0
Skin Sens. 1
OPALAL
424-030-2
62406-73-9
Skin Irrit. 2
273-688-5
69011-06-9
yes
265-748-4
65405-96-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
200-473-5
60-35-5
Carc. 2
200-580-7
64-19-7
Flam. Liq. 3; Skin Corr. 1A
200-662-2
67-64-1
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
270-651-5
68475-57-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-652-0
68475-58-1
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-653-6
68475-59-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-654-1
68475-60-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
272-924-4
68920-70-7
yes
263-004-3
61788-76-9
yes
262-977-1
61788-46-3
Acute Tox. 4; Asp. Tox. 1; STOT SE 3; STOT RE 2; Skin Corr. 1B
262-976-6
61788-45-2
Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
268-626-9
68131-73-7
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
268-626-9
68131-73-7
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
263-125-1
61790-33-8
Acute Tox. 4; Asp. Tox. 1; STOT RE 2; Skin Corr. 1B
200-521-5
61-82-5
Repr. 2; STOT RE 2
700-242-3
62037-80-3
yes
269-511-6
68259-08-5
yes
200-539-3
62-53-3
Carc. 2; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1; Skin Sens. 1
268-618-5
68131-49-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by the fractionation pyrolysis at 816°C (1500°F) of naphtha and raffinate. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8, including benzene.
270-658-3
68475-70-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
265-610-3
65195-55-3
Repr. 2; Acute Tox. 2; Acute Tox. 1; STOT RE 1
262-102-3
60207-31-0
Acute Tox. 4
620-425-0
68049-83-2
Repr. 1B; STOT RE 2
210-834-9
624-18-0
Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
200-618-2
65-85-0
STOT RE 1; Skin Irrit. 2; Eye Dam. 1
The distillate from coke oven light oil having an approximate distillation range below 100°C (212°F). Composed primarily of C4 to C6 aliphatic hydrocarbons.
266-023-5
65996-88-5
Carc. 1B; Muta. 1B
TINUVIN 780
402-940-0
62782-03-0
Eye Irrit. 2
DI(2-ETHYLHEXYL)DITHIODIGLYKOLAT; DP 327
404-510-8
62268-47-7
Acute Tox. 4; Skin Sens. 1
GR101655A
423-170-1
618-26-8
Flam. Liq. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
INTERSEPT
404-690-8
68132-19-4
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1

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