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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 22 srpnja 2024. Database contains 4821 unique substances/entries.
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426-840-1
-
Eye Dam. 1
PACIFIED REACTIVE BLACK 31
423-940-7
85585-91-7
Eye Dam. 1
DYE K
402-660-9
-
Repr. 1B
AZUL MARINHO 018112; BLEU MARINE 018112; NAVY 018112; NAVY BLUE 018112
405-665-4
118685-33-9
Skin Sens. 1
435-960-3
-
Carc. 1B; Muta. 1B; Skin Sens. 1
427-140-9
-
Carc. 2
OLOA 224 (OIL FREE)
420-470-4
-
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
MUGETANOL
407-640-3
63767-86-2
Eye Irrit. 2; Skin Irrit. 2
NEWLON AM-92I
407-490-9
-
Acute Tox. 4; Skin Corr. 1B
422-260-8
20701-68-2
Eye Dam. 1
CAMONAL
426-130-1
166301-21-9
Skin Irrit. 2
VESTAGON EP S 270
411-830-1
114765-88-7
Eye Dam. 1; Skin Sens. 1
429-990-6
-
Eye Dam. 1; Skin Sens. 1
SP 7077
430-180-1
-
Skin Irrit. 2
SP 7053
415-930-6
-
Repr. 2; Skin Sens. 1
DOW CORNING (R) 4-2920 INTERMEDIATE
406-930-7
96-29-7
STOT RE 1; Skin Sens. 1
417-050-8
151006-58-5
Acute Tox. 4
422-920-5
-
STOT RE 2
C.I. DIRECT VIOLET 9; VIOLET PERGASOL EN LIQUIDE
406-910-8
124649-82-7
Acute Tox. 4
MDI
406-550-1
-
Skin Sens. 1
MCP 455
406-240-6
-
Flam. Liq. 3; Skin Corr. 1B
A-88820.605
414-810-0
-
STOT RE 2; Eye Dam. 1
AMMONIUM DIAS
407-320-3
-
Skin Irrit. 2; Eye Dam. 1
DP 15
410-640-6
-
Skin Irrit. 2; Eye Dam. 1
INTERMEDIAIRE AR HT 3728
410-065-0
-
Skin Sens. 1

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