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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 02 listopada 2024. Database contains 4821 unique substances/entries.
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204-255-0
118-48-9
Eye Irrit. 2; Skin Sens. 1
413-720-9
117933-89-8
yes
413-720-9
117933-89-8
yes
RO 1082
411-260-3
117907-43-4
Eye Dam. 1; Skin Sens. 1
COUPLER II; UC-136
406-200-8
117827-06-2
Skin Sens. 1
ORANGE BIREACTIVE DYE
407-050-6
117715-57-8
Skin Sens. 1
DIPND-50-AL (META)
420-060-5
117663-11-3
Flam. Liq. 3; Org. Perox. D
CG 26-751
407-880-9
117549-13-0
Acute Tox. 4
IJA-286; IJBK-286; IJBK-286-LI
403-650-7
117409-78-6
Expl. 1.3
SUBSTANCE TP-415; SUBSTANZ TP-415; TP-415
404-760-8
117342-25-3
Acute Tox. 3; Eye Dam. 1
MAT 9460
414-080-3
117291-73-3
Acute Tox. 4
CSPC
411-010-3
117205-23-9
Skin Sens. 1
204-212-6
117-82-8
Repr. 1B
yes
204-211-0
117-81-7
Repr. 1B
yes
204-210-5
117-80-6
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
204-195-5
117-52-2
Acute Tox. 3; STOT RE 1
204-178-2
117-18-0
Acute Tox. 4; Skin Sens. 1
204-171-4
117-08-8
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
BLEU REACTIF 238; BLEU REATTIVO 238; C.I. REACTIVE BLUE 238; DISAZO MARINE TZ 2646; MARINE DIAZO TZ 2646; REACTIVE BLUE 238
404-320-5
116889-78-2
Skin Sens. 1
TP-302
404-860-1
116810-46-9
Flam. Sol. 1; Eye Dam. 1
KENODOX
404-300-6
116753-76-5
Org. Perox. C
LATEMUL S-180 A
410-540-2
116726-92-2
Skin Irrit. 2; Skin Sens. 1
214-620-6
1166-52-5
Skin Sens. 1
214-619-0
1166-46-7
Carc. 2; Acute Tox. 4; STOT SE 2
FOOD BLACK 2, TETRAMETHYLAMMONIUM SALT
405-170-3
116340-05-7
Acute Tox. 3; Skin Sens. 1
441-810-8
116313-85-0
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
214-604-9
1163-19-5
yes
T1314
411-500-7
116256-11-2
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
THANCAT AN 20
407-360-1
116230-20-7
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
2-ISOPROPYL-5-CARBOXY-1,3-DIOXANE
418-170-3
116193-72-7
Eye Dam. 1
427-090-8
116044-44-1
Skin Sens. 1
204-129-5
116-16-5
Acute Tox. 4
204-127-4
116-15-4
Press. Gas; Acute Tox. 4; STOT SE 3
204-126-9
116-14-3
Carc. 1B
204-123-2
116-06-3
Acute Tox. 2; Acute Tox. 3
204-121-1
116-01-8
Acute Tox. 4
-
115937-89-8
Repr. 1B; Acute Tox. 4; STOT RE 2
-
115850-69-6
Repr. 1B; Acute Tox. 4; STOT RE 2
PIGMENTROT 1017; SUBSTANCE H112287
405-100-1
115662-06-1
Repr. 2
BROWN 1619246
406-870-1
115100-55-5
Skin Sens. 1
BENACTIVE GOLDEN YELLOW CN-GL; C.I. REACTIVE YELLOW 178; KAYACELON REACT GOLDEN YELLOW CN-GL; SOMAZIN GOLDEN YELLOW CN-GL
404-250-5
115099-55-3
Skin Sens. 1
H: SÄUREGELB 2829
401-870-8
115035-41-1
Eye Dam. 1
204-118-5
115-96-8
Carc. 2; Repr. 1B; Acute Tox. 4
yes
204-114-3
115-90-2
Acute Tox. 1; Acute Tox. 2
204-105-4
115-78-6
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
204-082-0
115-32-2
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
204-081-5
115-31-1
Acute Tox. 4
204-079-4
115-29-7
Acute Tox. 2; Acute Tox. 4
204-077-3
115-27-5
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
204-076-8
115-26-4
Acute Tox. 1; Acute Tox. 2

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