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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 21 lipnja 2024. Database contains 4821 unique substances/entries.
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2,2'-AZOBIS(2-METHYL-N-(2-HYDROXYETHYL)PROPIONAMID)
429-090-3
61551-69-7
Skin Sens. 1
SCARLET DER 8107
429-070-4
214362-06-8
Eye Dam. 1
429-040-0
272460-97-6
Eye Dam. 1
CP-328,914
429-030-6
57999-49-2
Skin Sens. 1
429-020-1
204254-96-6
STOT RE 2; Skin Sens. 1
4-ALLYLOXYBENZOESÄURE-(4-METHACRYLOYL)PHENYLESTER
429-000-2
159235-16-2
Skin Sens. 1
428-970-4
13595-25-0
Repr. 2; Skin Sens. 1
428-790-6
72963-72-5
Carc. 2; Acute Tox. 4; STOT SE 2
428-700-5
1873-90-1
Acute Tox. 4
428-690-2
1668-86-6
Acute Tox. 4; Eye Irrit. 2
428-650-4
153719-23-4
Repr. 2; Acute Tox. 4
428-630-5
-
Skin Sens. 1
428-410-9
67014-36-2
Acute Tox. 4; Skin Sens. 1
428-400-4
-
Eye Dam. 1
428-390-1
86393-34-2
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
H-604
428-350-3
93629-90-4
Muta. 2; Eye Dam. 1; Skin Sens. 1
428-340-9
238088-70-5
Skin Irrit. 2
428-330-4
2833-30-9
Skin Corr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
428-320-1
71308-16-2
Acute Tox. 4; Skin Sens. 1
BM 96.0258.HCL
428-290-8
120606-08-8
Acute Tox. 4; Eye Dam. 1
428-260-4
-
Eye Dam. 1
428-230-0
79568-06-2
STOT RE 2
428-100-3
94239-04-0
Flam. Liq. 3; Acute Tox. 4
428-070-1
91788-83-9
STOT RE 1; Acute Tox. 4
428-050-2
-
Skin Sens. 1
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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