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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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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BONTRON E-88
406-890-0
130296-87-6
Acute Tox. 4
MCP 938
410-720-0
141847-13-4
Eye Dam. 1
435-450-0
5460-63-9
Skin Sens. 1
424-290-7
188070-47-5
Skin Sens. 1
434-240-6
-
Skin Sens. 1
REACTIVE YELLOW FC 75560
419-450-8
-
Skin Sens. 1
430-050-2
-
Skin Sens. 1
414-340-6
-
Flam. Liq. 3; Acute Tox. 4; STOT SE 2; Eye Dam. 1; Skin Sens. 1
PERGASCRIPT BLACK 20223 AMIDE INTERMEDIATE
420-600-1
-
STOT RE 2
VERNETZER TMAG
412-790-8
-
Carc. 1B; Muta. 2; STOT RE 2
COMPLEXING AGENT BN
410-650-0
-
Eye Dam. 1; Skin Sens. 1
423-580-0
-
STOT RE 2
423-010-0
-
Eye Dam. 1
444-290-0
508202-43-5
Eye Dam. 1; Skin Sens. 1
450-010-8
-
Eye Dam. 1; Skin Sens. 1
432-100-9
-
Eye Dam. 1
445-280-9
371921-40-3
Eye Dam. 1; Skin Sens. 1
MARINE REN 600
424-320-9
180778-23-8
Eye Dam. 1
COLUMBIADUNKELBLAU R
415-350-3
-
Eye Dam. 1
422-500-1
-
STOT RE 2
433-860-4
-
Eye Irrit. 2; Skin Sens. 1
T-271
417-980-4
157321-59-0
Self-react. C; Carc. 2
EVAPORATED ELEMINOL JS-2 MATERIAL
410-230-7
-
Skin Corr. 1B; Skin Sens. 1
TASP
411-250-9
-
Skin Sens. 1
426-470-0
214897-29-7
Skin Sens. 1
427-740-0
-
Eye Dam. 1; Skin Sens. 1
C.I. DIRECT VIOLET 107; PRO-JET FAST MAGENTA 2 COLOUR; S161629
413-180-4
187285-15-0
Eye Dam. 1
DRIMAREN NAVY R-GRL; NAVY 14 08 723
407-100-7
-
Skin Sens. 1
ACID RED HT 3728; ERIONYL RED HT 3728
410-070-8
141880-36-6
Skin Sens. 1
432-790-1
847871-03-8
Acute Tox. 4; Skin Corr. 1B; STOT SE 2
PRIAZUL MYRISTOYL LACTYLATE; PRICARE MYRISTYL LACTYLATE (1:1.5)
412-580-6
174591-51-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
PRICARE
411-910-6
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
429-440-5
-
Eye Dam. 1
PROCION YELLOW PX-R; S154357; SUBSTANCE S154357
412-940-2
148878-18-6
Skin Sens. 1
ITC 288/S
410-800-5
-
Skin Sens. 1
EBO
417-540-1
-
Eye Dam. 1
BDS-HEXAFLUOROPHOSPHATE; BDS-HEXAFLUORPHOSPHAT; ESACURE 1004
404-986-7
74227-35-3
Eye Dam. 1
CYRACURE PHOTOINITIATOR UVI-6990; CYRACURE PHOTOINITIATOR UVI-6992
403-490-8
104558-95-4
Eye Irrit. 2; Skin Sens. 1
ACETOXYACID
411-660-8
147027-04-1
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
2-ISOPROPYL-5-CARBOXY-1,3-DIOXANE
418-170-3
116193-72-7
Eye Dam. 1
CLARYCET
412-450-9
131766-73-9
Skin Sens. 1
429-620-3
110028-14-3
Skin Irrit. 2; Skin Sens. 1
432-230-6
-
STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
438-310-7
-
Self-react. C; Repr. 2; Acute Tox. 4; STOT RE 2
ARQUAD 3.16
405-620-9
-
Eye Dam. 1
DUASYN DIREKTSCHWARZ HEF-SF VP 332
411-890-9
108936-08-9
Acute Tox. 4; Eye Dam. 1
C.I. DIRECT BLACK 184; C.I. DIRECT NOIR 184
406-000-0
173939-66-7
Eye Dam. 1
BROWN 1619246
406-870-1
115100-55-5
Skin Sens. 1
428-260-4
-
Eye Dam. 1
REACTIVE RED 180 (HYDROLYSED)
423-200-3
98114-32-0
Eye Dam. 1; Skin Sens. 1

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