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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 24 srpnja 2024. Database contains 4821 unique substances/entries.
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238-887-3
14816-18-3
Repr. 2; Acute Tox. 4; Skin Sens. 1
421-360-9
148043-73-6
Acute Tox. 4
205-711-1
148-24-3
Repr. 1B; Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
DOWFAX (R) DRY HYDROTROPE POWDER
429-650-7
147732-60-3
Eye Irrit. 2
YELLOW E-JD 3442
410-150-2
147703-65-9
Skin Sens. 1
SCARLET X-GA 1491
410-390-8
147703-64-8
Eye Dam. 1
LICHTSCHUTZMITTEL 1071
413-510-7
147374-67-2
STOT RE 2; Skin Sens. 1
238-766-5
14721-18-7
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
FCC 963
410-880-1
147170-38-5
Acute Tox. 4; Skin Corr. 1B
939-460-0
1471311-26-8
yes
FC4010
417-290-3
147086-81-5
Acute Tox. 4
238-753-4
14708-14-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
ACETOXYACID
411-660-8
147027-04-1
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
C.I. DISPERSE RED 367
403-960-2
147014-52-6
Skin Sens. 1
423-840-3
14691-89-5
Acute Tox. 4
215-993-8
1468-37-7
Acute Tox. 4
LUPEROX 610-E-35; LUPEROX 610-E-50; LUPEROX 610-EN-50; LUPEROX 610-M-50; LUPERSOL 610; LUPERSOL 610-M-50
413-910-1
1467668-33-2
Org. Perox. C; Flam. Liq. 3; Skin Irrit. 2
FYROL 3-HPP; HIRETAR-205; PHOSGARD PF 100
411-200-6
14657-64-8
Eye Dam. 1
POWDERLINK (R) MTSI
415-040-8
14653-91-9
Acute Tox. 4; STOT SE 3; Eye Dam. 1
215-979-1
1464-53-5
Carc. 1B; Muta. 1B; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
FAT 40'436; FAT 40'436/A; REACTIVE ORANGE TZ 3538
410-770-3
146177-84-6
Skin Sens. 1
415-500-8
145963-84-4
Acute Tox. 4; STOT RE 2
238-596-1
14550-87-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
215-925-7
1453-58-3
Repr. 1B; Acute Tox. 4; STOT RE 2; Skin Corr. 1; Eye Dam. 1
433-910-5
145153-52-2
Skin Sens. 1
238-511-8
14507-36-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
CGI 403
412-010-6
145052-34-2
Skin Sens. 1
205-660-5
145-73-3
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
215-910-5
1449-55-4
Acute Tox. 4
238-484-2
14484-64-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
JE 127
421-220-7
144740-59-0
Skin Sens. 1
PC-709
413-420-8
144736-29-8
Skin Corr. 1B; Skin Sens. 1
604-430-5
144651-06-9
STOT RE 2
238-426-6
14448-18-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
238-413-5
14437-17-3
Acute Tox. 4
447-860-7
144177-62-8
Repr. 2; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
604-398-2
144171-61-9
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 1B
444-250-2
144111-81-9
Self-react. C
604-395-6
14409-72-4
yes
205-634-3
144-62-7
Acute Tox. 4
205-631-7
144-49-0
Acute Tox. 2
205-628-0
144-41-2
Acute Tox. 3
418-370-0
143925-92-2
Skin Sens. 1
ZOLDINE MS-PLUS
421-150-7
143860-04-2
Repr. 1B; Skin Corr. 1B
yes
BLEU REACTIF TZ 3533; BLEU REACTIVE TZ 3533; FAT 41'017/A; REACTIVE BLUE TZ 3533
411-240-4
143683-23-2
Skin Sens. 1
1,3-DICHLOR-4-FLUORBENZOL; B-7
406-160-1
1435-48-9
Acute Tox. 4; STOT RE 2; Skin Irrit. 2
SB-201999
415-680-8
143468-96-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
433-530-1
143446-73-5
Acute Tox. 4; Skin Sens. 1
604-351-6
143390-89-0
Carc. 2
UK-111,975
422-390-5
143322-57-0
Repr. 2; STOT RE 1; Acute Tox. 4; Skin Sens. 1
238-278-2
14332-34-4
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
238-270-9
14324-55-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
238-253-6
14312-40-4
yes
205-601-3
143-50-0
Carc. 2; Acute Tox. 3
205-594-7
143-24-8
Repr. 1B
yes
205-592-6
143-22-6
Eye Dam. 1
604-318-6
142891-20-1
Carc. 2; Skin Sens. 1
439-360-2
142877-45-0
Skin Irrit. 2; Eye Dam. 1
UM-229
407-070-5
142859-67-4
Skin Sens. 1
604-314-4
142844-00-6
yes
635-391-2
142731-63-3
yes
PARMANYL
415-220-6
142653-61-0
Acute Tox. 3; Acute Tox. 4
238-134-9
14255-88-0
Acute Tox. 4
604-291-0
142469-14-5
Skin Sens. 1
604-290-5
142459-58-3
Acute Tox. 4; STOT RE 2; Skin Sens. 1
238-076-4
14216-75-2
Ox. Sol. 2; Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
215-813-8
1420-07-1
Repr. 1B; Acute Tox. 2; Acute Tox. 3
215-812-2
1420-06-0
Acute Tox. 4
205-575-3
142-96-1
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
205-570-6
142-90-5
STOT SE 3
205-565-9
142-84-7
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
205-563-8
142-82-5
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
205-551-2
142-64-3
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
205-547-0
142-59-6
Acute Tox. 4; STOT SE 3; Skin Sens. 1
430-220-6
141942-85-0
Eye Irrit. 2
AF-389
407-990-7
141915-64-2
Skin Sens. 1
AMINO CATION S-36
414-670-0
141890-30-4
Acute Tox. 4; Eye Dam. 1
ACID RED HT 3728; ERIONYL RED HT 3728
410-070-8
141880-36-6
Skin Sens. 1
MCP 938
410-720-0
141847-13-4
Eye Dam. 1
822-682-6
1417782-03-6
Skin Sens. 1
427-020-6
141772-37-4
STOT RE 2; Skin Sens. 1
238-034-5
14177-55-0
Carc. 1A; STOT RE 1; Skin Sens. 1
238-032-4
14177-51-6
Carc. 1A; STOT RE 1; Skin Sens. 1
IRB
418-070-1
141714-54-7
Skin Sens. 1
238-009-9
14166-21-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
BUTAMINONITRODARONE; SR33581
444-800-1
141645-23-0
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
604-237-6
141517-21-7
Lact.; Skin Sens. 1
435-350-7
141250-43-3
Eye Dam. 1
604-222-4
141112-29-0
Repr. 2
NAVY 14 05 711
411-470-5
141048-13-7
Skin Sens. 1
205-502-5
141-79-7
Flam. Liq. 3; Acute Tox. 4
205-500-4
141-78-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
205-498-5
141-75-3
Flam. Liq. 2; Skin Corr. 1B
205-494-3
141-66-2
Acute Tox. 2; Acute Tox. 3
205-487-5
141-52-6
Self-heat. 1; Skin Corr. 1B
205-483-3
141-43-5
Acute Tox. 4; Skin Corr. 1B
205-480-7
141-32-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
604-209-3
140923-17-7
Carc. 2
HÄRTER VERSUCHSPRODUKT LS 2959E; HÄRTER VP LS 2959E
411-700-4
140921-24-0
Skin Sens. 1
C.I. REACTIVE YELLOW 138:1
403-810-6
140876-13-7
Eye Dam. 1

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