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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 11 rujna 2024. Database contains 4821 unique substances/entries.
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428-040-8
138261-41-3
Acute Tox. 3
428-030-3
67914-69-6
Acute Tox. 4; STOT RE 2
428-020-9
6195-20-6
Skin Sens. 1
CP-166,221
428-010-4
82413-20-5
Carc. 2; Repr. 1B; Skin Sens. 1
427-930-3
250639-69-1
Skin Sens. 1
427-880-2
90357-53-2
STOT RE 2
427-870-8
6903-18-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
427-850-9
202667-43-4
Skin Sens. 1
427-780-9
114565-70-7
Acute Tox. 4; Eye Dam. 1
3,3-TETRAMETHYLENE GLUTARIMIDE
427-770-4
1075-89-4
Acute Tox. 3
427-740-0
-
Eye Dam. 1; Skin Sens. 1
427-730-6
202420-04-0
Skin Corr. 1B
427-720-1
26364-65-8
Acute Tox. 4; STOT RE 2
427-710-7
215612-56-9
Eye Dam. 1; Skin Sens. 1
TRIETHYLARSENAT; TRIETHYLARSENATE; TRIETHYLARSENATE (TEASAT)
427-700-2
15606-95-8
Carc. 1A; Acute Tox. 3
yes
427-680-5
188907-52-0
Eye Dam. 1; Skin Sens. 1
ECPA
427-630-2
99469-99-5
Eye Dam. 1
427-580-1
211299-54-6
Skin Irrit. 2
427-480-8
176429-22-4
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
427-470-3
137864-22-3
Acute Tox. 4; Skin Sens. 1
427-450-4
152630-47-2
Acute Tox. 4; STOT RE 2; Skin Sens. 1
FPB 800
427-400-1
140623-89-8
Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
SUBSTANCE S171393
427-390-9
-
Skin Sens. 1
427-370-1
164288-56-6
Eye Dam. 1
4-(4-BUTYLCYCLOHEXYL)-ACETOPHENON
427-320-7
83626-30-6
Skin Sens. 1

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