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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 14 lipnja 2024. Database contains 4821 unique substances/entries.
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DCEMH
401-570-7
89415-87-2
Ox. Sol. 1; Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
REACTIVE BLUE FC 05 717
401-560-2
108624-00-6
Skin Sens. 1
TETRACHLOROTEREPHTHALONITRILE
401-550-8
1897-41-2
Skin Sens. 1
SHC 3000
401-530-9
-
Flam. Sol. 1; STOT SE 1; Acute Tox. 4
CARTASOL GEEL M-GL CONC.; CARTASOL GELB M-GL FLÜSSIG (ZUBEREITUNG); CARTASOL GELB M-GL KONZ.; CARTASOL YELLOW M-GL CONC.; HM 2580
401-500-5
118658-99-4
Carc. 1B
128719
401-460-9
82560-06-3
Acute Tox. 3; Eye Dam. 1
(2-BENZOTHIAZOLYLTHIO)BERNSTEINSÄURE; BTTBS; HALOX 650; IRGACOR 252
401-450-4
95154-01-1
Skin Sens. 1
HOSTALUX VP 3481
401-410-6
10357-99-0
STOT RE 2; Skin Sens. 1
U 9649
401-380-4
89066-61-5
Eye Irrit. 2
2-METHOXY-4-METHYL-6-METHYLAMINO-1,3,5-TRIAZIN; DPX-L5296; L5296
401-360-5
5248-39-5
Acute Tox. 4; STOT RE 2
F5384
401-340-6
83055-99-6
Skin Sens. 1
DURALINK (R) HTS; ERP-390
401-320-7
5719-73-3
Skin Sens. 1
HOE 70542
401-290-5
103112-35-2
Carc. 1B
CM 23-376; REOMET 30
401-280-0
91273-04-0
Skin Corr. 1B; Skin Sens. 1
CARTASOL TUERKIS K-ZBL KONC.; CARTASOL TURQUOISE K-JD 2336; CARTASOL TURQUOISE K-JD 2336 CONC.; CARTASOL TURQUOISE K-ZBL CONC.; CARTASOL TÜRKIS K-ZBL FLÜSSIG; CARTASOL TÜRKIS K-ZBL KONZ.; TURQUOISE CARTASOL K-JD 2336 CONC.
401-260-1
118800-27-4
Eye Irrit. 2
SÄUREBRAUN 6230
401-220-3
-
Acute Tox. 4
401-190-1
101200-48-0
STOT RE 2; Skin Sens. 1
ISOBUTYLVINYL ACETATE; IVA
401-170-2
24342-03-8
Flam. Liq. 3
CS 100; SILOXAL
401-160-8
55426-95-4
Water-react. 1; Pyr. Liq. 1; Skin Corr. 1A
401-130-4
71526-07-3
Skin Sens. 1
TILCOM CA35; TILCOM IA10; TYTAN AP 100; TYTAN CA 100; TYTAN CX 35; TYZOR IAM
401-100-0
109037-78-7
Flam. Liq. 2; Eye Irrit. 2
PM 9879
401-060-4
121518-45-4
Skin Corr. 1B
DBB
401-040-5
75113-37-0
Repr. 1B; Muta. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
REACTIVE ORANGE F-64 258 FW
401-010-1
106027-83-2
Skin Sens. 1
X 3761
400-930-0
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
2,3-ISOPROPYLIDENE DIOXYPHENOL
400-900-7
22961-82-6
Eye Dam. 1
EVERSORB 80; TINUVIN 1130; TINUVIN 213
400-830-7
-
Skin Sens. 1
BI 3277; NOIR CORSE SANODAL H3LW CONC.; SANODAL DEEP BLACK H-3LW CONC.; SANODAL TIEFSCHWARZ H-3LW; SANODAL TIEFSCHWARZ H-3LW KONZ.
400-810-8
106084-79-1
Muta. 2
C.I. REACTIVE RED 220; CIBACRON-RED F-2G; CIBACRON-ROT F-2G; REACTIVE RED 220; ROSSO REATTIVO 220; ROUGE REACTIF 220
400-790-0
85665-97-0
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
PIGMENTGELB 82 897
400-710-4
94612-72-3
Acute Tox. 4
R-GELB 2454
400-680-2
98181-47-6
Acute Tox. 4
2-NITROBENZYLIDENE METHYL ESTER; BAY O 2787
400-650-9
39562-27-1
Skin Sens. 1
ACETOCURE 97; GENOCURE*PMP; IGM 4817; IRGACURE 907; SPEEDCURE 97
400-600-6
71868-10-5
Repr. 1B; Acute Tox. 4
yes
HOSTAVIN N 24; SANDUVOR 3050; VP SANDUVOR 3050
400-580-9
85099-50-9
Skin Irrit. 2
C.I. DIRECT BLACK 174
400-570-4
162994-84-5
Eye Irrit. 2
AF-336
400-530-6
723-38-6
Eye Dam. 1; Skin Sens. 1
Z-2
400-520-1
164907-74-8
Skin Corr. 1B; Acute Tox. 4
BLEU MARINE DRIMARENE X-GN PKT; BLEU MARINE X-VT 4046; DRIMAREN MARINEBLAU X-GN PKT; DRIMAREN NAVY X-GN PKT; NAVY BLUE X-VT 4046
400-510-7
85665-98-1
Eye Dam. 1; Skin Sens. 1
C.I. DISPERSE BLUE 356
400-460-6
118578-14-6
Skin Sens. 1
C.I. REACTIVE BROWN 44
400-430-2
95078-21-0
Skin Sens. 1
1,3-PDTA; AGENT CHELATANT KODAK NO.1; DISSOLVINE PDZ; HAMPSHIRE PDTA; KODAK CHELATING AGENT NO.1; TRILON R FS
400-400-9
1939-36-2
Acute Tox. 4; Eye Dam. 1
FLEXSORB-SE
400-390-6
87787-67-5
Skin Corr. 1A; Acute Tox. 4
DRIMAREN SCHARLACH X-GA 979; DRIMAREN SCHARLAKEN X-GA; DRIMAREN SCHARLAKEN X-GA 979; DRIMARENE SCARLET X-2 GN; ECARLATE DRIMARENE X-2GN; ECARLATE DRIMARENE X-GA 979; ECARLATE X-GA 979; SCARLET X-GA 979
400-380-1
86393-35-3
Skin Sens. 1
ACID BLUE 344; BLEU ACIDE 344; BLEU ACIDO 344; BLU ACIDO 344; C.I. ACID BLUE 344; SÄURE BLAU 344
400-350-8
85153-93-1
Eye Dam. 1
ARANCIO DISPERSO 149; C.I. DISPERSE ORANGE 149; DISPERS ORANGE 149; DISPERSE ORANGE 149; ORANGE DISPERSE 149; TERASIL GOLDGELB 2RS
400-340-3
85136-74-9
Carc. 1B
G.1417
400-290-2
69045-82-5
Flam. Liq. 3; Skin Sens. 1
C.I. REACTIVE RED 219
400-130-1
149057-72-7
Resp. Sens. 1
AIZEN SPILON BLACK TRH; AIZEN SPILON SCHWARZ TRH; THR-1; TRH
400-110-2
109125-51-1
Self-react. C
C.I. BLEU REACTIF 204; C.I. REACTIVE BLUE 204; REACTIVE BLUE 204; REAKTIV BLAU 204
400-050-7
85153-92-0
Resp. Sens. 1; Skin Sens. 1
EURELYT
400-040-2
12091-08-6
Flam. Sol. 1; Water-react. 1; Skin Corr. 1A; Acute Tox. 4

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