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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

RELEVANT LEGISLATION
Last updated 11 listopada 2024. Database contains 4821 unique substances/entries.
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Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU_BA Directive 2000/54/EC
EU REACH: List of SVHC
reaction mass of: 5-(N-methylperfluorooctylsulfonamido)methyl-3-octadecyl-1,3-oxazolidin-2-one; 5-(N-methylperfluoroheptylsulfonamido)methyl-3-octadecyl-1,3-oxazolidin-2-one
T-4240 FLUOROCHEMICAL URETHANE DERIVATIVE
413-640-4
-
STOT RE 2
reaction mass of: 5-[(4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)azo]-2,5-diethoxyphenyl)azo]-2-[(3-phosphonophenyl)azo]benzoic acid; 5-[(4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)azo]-2,5-diethoxyphenyl)azo]-3-[(3-phosphonophenyl)azo]benzoic acid
BONJET BLACK 817
418-230-9
163879-69-4
Expl. 1.3; Repr. 2; STOT RE 2; Skin Sens. 1
reaction mass of: 7,9,9-trimethyl-3,14-dioxa-4,13-dioxo-5,12-diazahexadecane-1,16-diyl-prop-2-enoate; 7,7,9-trimethyl-3,14-dioxa-4,13-dioxo-5,12-diazahexadecane-1,16-diyl-prop-2-enoate
MONO 442
412-260-6
52658-19-2
Eye Irrit. 2; Skin Sens. 1
reaction mass of: 7-(((3-aminophenyl)sulfonyl)amino)-naphthalene-1,3-disulfonic acid; sodium 7-(((3-aminophenyl)sulfonyl)amino)-naphthalene-1,3-disulfonate; potassium 7-(((3-aminophenyl)sulfonyl)amino)-naphthalene-1,3-disulfonate
INTERMEDIAIRE AR HT 3728
410-065-0
-
Skin Sens. 1
reaction mass of: [1-(methoxymethyl)-2-(C12-alkoxy)-ethoxy]acetic acid; [1-(methoxymethyl)-2-(C14-alkoxy)-ethoxy]acetic acid
DP 15
410-640-6
-
Skin Irrit. 2; Eye Dam. 1
reaction mass of: ammonium-1,2-bis(hexyloxycarbonyl)ethanesulfonate; ammonium-1-hexyloxycarbonyl-2-octyloxycarbonylethanesulfonate; ammonium-2-hexyloxycarbonyl-1-octyloxycarbonylethanesulfonate
AMMONIUM DIAS
407-320-3
-
Skin Irrit. 2; Eye Dam. 1
reaction mass of: bis(1S,2S,4S)-(1-benzyl-4-tert-butoxycarboxamido-2-hydroxy-5-phenyl)pentylammonium succinate; isopropyl alcohol
A-88820.605
414-810-0
-
STOT RE 2; Eye Dam. 1
reaction mass of: bis(isotridecylammonium)mono(di-(4-methylpent-2-yloxy)thiophosphorothionylisopropyl)phosphate; isotridecylammonium bis(di-(4-methylpent-2-yloxy)thiophosphorothionylisopropyl)phosphate
MCP 455
406-240-6
-
Flam. Liq. 3; Skin Corr. 1B
reaction mass of: bis(N-cyclohexyl-N'-phenyleneureido)methylene; bis(N-octadecyl-N'-phenyleneureido)methylene; bis(N-dicyclohexyl-N'-phenyleneureido)methylene (1:2:1)
MDI
406-550-1
-
Skin Sens. 1
reaction mass of: bis(tris(2-(2-hydroxy(1-methyl)ethoxy)ethyl)ammonium) 7-anilino-4-hydroxy-3-(2-methoxy-5-methyl-4-(4-sulfonatophenylazo)phenylazo)naphthalene-2-sulfonate; bis(tris(2-(2-hydroxy(2-methyl)ethoxy)ethyl)ammonium) 7-anilino-4-hydroxy-3-(2-methoxy-5-methyl-4-(4-sulfonatophenylazo)phenylazo)naphthalene-2-sulfonate
C.I. DIRECT VIOLET 9; VIOLET PERGASOL EN LIQUIDE
406-910-8
124649-82-7
Acute Tox. 4
Stranica 436 od 483
10 Broj stavki po stranici
Prikazano 4.351 - 4.360 od 4.821 rezultata.

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