EU-IMPLANTABLE_MEDICAL_DEVICES-ART_3_ANX_1

Active Implantable Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Directive 90/385/EEC on Active Implantable Medical Devices, 20 July 1990, amended by Directive 2007/47/EC, 21 September 2007

This list contains hazardous substances for purposes of Directive 90/385/EEC on active implantable medical devices, particularly as regards Article 3 and Annex I (Essential Requirements). This non-exhaustive database 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). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

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Last updated 26 April 2024. Database contains 4753 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
trinickel bis(arsenate); nickel(II) arsenate
236-771-7
13477-70-8
Carc. 1A; STOT RE 1; Skin Sens. 1
trinickel bis(arsenite)
-
74646-29-0
Carc. 1A; STOT RE 1; Skin Sens. 1
trinickel bis(orthophosphate)
233-844-5
10381-36-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
trinickel boride
234-495-1
12007-02-2
Carc. 1A; STOT RE 1; Skin Sens. 1
trinickel disulfide; nickel subsulfide
234-829-6
12035-72-2
Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1
trinickel tetrasulfide
-
12137-12-1
Carc. 1A; STOT RE 1; Skin Sens. 1
trioctylstannane
TZ 02508
413-320-4
869-59-0
STOT RE 1; Skin Irrit. 2
trioctyltin compounds, with the exception of those specified elsewhere in this Annex
-
-
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
triphenyl phosphite
202-908-4
101-02-0
Eye Irrit. 2; Skin Irrit. 2
triphenyl(phenylmethyl)phosphonium 1,1,2,2,3,3,4,4,4-nonafluoro-N-methyl-1-butanesulfonamide (1:1)
442-960-7
332350-93-3
Acute Tox. 3; Eye Dam. 1
triphenyltin compounds, with the exception of those specified elsewhere in this Annex
-
-
Acute Tox. 3
tripropylammonium dihydrogenphosphate
TRYPROPYLAMMONIUM DIHYDROGENPHOSPHAT
433-700-3
35687-90-2
Acute Tox. 4
tripropyltin compounds, with the exception of those specified elsewhere in this Annex
-
-
Acute Tox. 3
tris(1-dodecyl-3-methyl-2-phenylbenzimidazolium)hexacyanoferrate
-
7276-58-6
Acute Tox. 4
tris(2-(2-hydroxyethoxy)ethyl)ammonium 3-acetoacetamido-4-methoxybenzenesulfonate
ACETOACETYLORTHOSINIC ACID, A6-SALT
403-760-5
68030-79-5
Skin Sens. 1
tris(2-chloroethyl)phosphate
204-118-5
115-96-8
Carc. 2; Repr. 1B; Acute Tox. 4
yes
tris(2-methoxyethoxy)vinylsilane; 6-(2-methoxyethoxy)-6-vinyl-2,5,7,10-tetraoxa-6-silaundecane
213-934-0
1067-53-4
Repr. 1B
Tris(4-nonylphenyl, branched) phosphite
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tris(4-nonylphenyl, branched) phosphite EC / List no: 701-028-2 | CAS no: -
Phenol, p-sec-nonyl-, phosphite EC / List no: - | CAS no: 106599-06-8
Phenol, 4-nonyl-, phosphite (3:1) EC / List no: 608-492-4 | CAS no: 3050-88-2
Tris(nonylphenyl) phosphite EC / List no: 247-759-6 | CAS no: 26523-78-4
Phenol, p-isononyl-, phosphite (3:1) EC / List no: - | CAS no: 31631-13-7
799-976-5
-
yes
tris(nonylphenyl) phosphite
247-759-6
26523-78-4
Skin Sens. 1
yes
tris(octadec-9-enylammonium) (trisulfonatophthalocyaninato)copper(II)
PIGMENTBLAU 1755
403-210-4
108300-90-9
Eye Dam. 1
tris(tetramethylammonium) 5-hydroxy-1-(4-sulphonatophenyl)-4-(4-sulphonatophenylazo)pyrazole-3-carboxylate
LEXMARK YELLOW DYE 415; PRISM YELLOW
406-073-9
131013-81-5
Acute Tox. 3
tris[2-chloro-1-(chloromethyl)ethyl] phosphate
237-159-2
13674-87-8
Carc. 2
trisodium (1-(3-carboxylato-2-oxido-5-sulfonatophenylazo)-5-hydroxy-7-sulfonatonaphthalen-2-amido)nickel(II)
BROWN 1612969
407-110-1
480445-87-2
Eye Dam. 1; Skin Sens. 1
trisodium (6-anilino-2-(5-nitro-2-oxidophenylazo)-3-sulphonato-1-naphtholato)(4-sulphonato-1,1'-azodi-2,2'naphtholato)chromate(1-)
SÄUREBLAU 82 226
402-500-8
104105-46-6
Eye Dam. 1
trisodium 1-hydroxynaphthalene-2-azo-4'(5',5''-dimethylbiphenyl)-4''-azo(4''-phenylsulfonyloxybenzene)-2',2'',4-trisulfonate
SCARLET 12 04 262
406-820-9
159317-41-6
Eye Irrit. 2
trisodium 2-{α[2-hydroxy-3-[4-chloro-6-[4-(2,3-dibromopropionylamino)-2-sulfonatophenylamino]-1,3,5-triazin-2-ylamino]-5-sulfonatophenylazo]-benzylidenehydrazino}-4-sulfonatobenzoate, copper complex
BLUE TZ 4312
423-770-3
-
Eye Dam. 1
trisodium 3-[2-acetylamino-4-[4-chloro-6-[4-(2-sulfonatoxyethylsulfonyl)phenylamino]-1,3,5-triazine-2-ylamino]phenylazo]naphthalene-1,5-disulfonate
427-710-7
215612-56-9
Eye Dam. 1; Skin Sens. 1
trisodium 3-amino-4-[4-[4-(2-(2-ethenylsulfonylethoxy)ethylamino)-6-fluoro-1,3,5-triazine-2-ylamino]-2-sulfophenylazo]-5-hydroxynaphthalene-2,7-disulfonate
429-240-8
212652-59-0
Eye Dam. 1
trisodium 3-amino-6,13-dichloro-10-((3-((4-chloro-6-(2-sulfophenylamino)-1,3,5-triazin-2-yl)amino)propyl) amino)-4,11-triphenoxydioxazinedisulfonate
BLEU REACTIF CAC 10; DIOXAZINE MONCHLORTRIAZINE; FAT NO. 40 407; REACTIVE BLUE CAC 10
410-130-3
136248-03-8
Skin Sens. 1
trisodium 4-hydroxy-6-(sulfonatomethylamino)-5-(2-(2-sulfatoethylsulfonyl)phenylazo)naphthalene-2-sulfonate
430-280-3
844491-96-9
Skin Sens. 1
trisodium 5-{[4-chloro-6-(1-naphthylamino)-1,3,5-triazin-2-yl]amino}-4-hydroxy-3-[(E)-(4-methoxy-2-sulfonatophenyl)diazenyl]-2,7-naphthalenedisulfonate
440-480-2
341026-59-3
Eye Dam. 1; Skin Sens. 1
trisodium 7-(4-(6-fluoro-4-(2-(2-vinylsulphonylethoxy)ethylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulphonate
C.I. REACTIVE YELLOW 174; GIALLO REATTIVO 174; JAUNE REACTIF 174; REAKTIV GELB 174
402-170-5
106359-91-5
Skin Sens. 1
trisodium [1,2'-(2-(8-amino-3,5-disulfonatonaphthalene)azo)-(4'-nitrobenzene)diolato-O, O,N][(Z)-2,2-((phenylcarbamoylprop-1'-enyl)azo)-5-sulfamoylbenzene)diolato-O, O,N]chromate(III)
423-100-1
-
Eye Dam. 1
trisodium [2-(5-chloro-2,6-difluoropyrimidin-4-ylamino)-5-(b-sulfamoyl-c, d-sulfonatophthalocyanin-a-yl-K4, N29, N30, N31, N32-sulfonylamino)benzoato(5-)]cuprate(II) where a =1,2,3,4 b = 8,9,10,11 c = 15,16,17,18 d = 22,23,24,25
TURQUOISE 10 40 518
411-430-7
-
Eye Dam. 1; Skin Sens. 1
trisodium [4'-(8-acetylamino-3,6-disulfonato-2-naphthylazo)-4''-(6-benzoylamino-3-sulfonato2-naphthylazo)-biphenyl 1,3',3'',1'''-tetraolato-O,O',O'',O''']copper(II)
SOLAMINLICHTBLAU VGRL 133
413-590-3
164058-22-4
Carc. 1B
trisodium bis(2-(5-chloro-4-nitro-2-oxidophenylazo)-5-sulphonato-1-naphtholato)chromate(1-)
ACID BLUE 349; AZO-METALCOMPLEX-BLUE AP 1149; BLEU ACIDE 349; C.I. ACID BLUE 349; SELLASET BLEU H; SELLASET BLUE H
402-870-0
93952-24-0
Eye Dam. 1
trisodium bis(7-acetamido-2-(4-nitro-2-oxidophenylazo)-3-sulphonato-1-naphtholato)chromate(1-)
BI 3277; NOIR CORSE SANODAL H3LW CONC.; SANODAL DEEP BLACK H-3LW CONC.; SANODAL TIEFSCHWARZ H-3LW; SANODAL TIEFSCHWARZ H-3LW KONZ.
400-810-8
106084-79-1
Muta. 2
trisodium bis[(3'-nitro-5'-sulfonato(6-amino-2-[4-(2-hydroxy-1-naphtylazo)phenylsulfonylamino]pyrimidin-5-azo)benzene-2',4-diolato)]chromate(III)
RED JB 747
418-220-4
-
Skin Sens. 1
trisodium hexafluoroaluminate
237-410-6
13775-53-6
STOT RE 1; Acute Tox. 4
trisodium hexafluoroaluminate(cryolite)
239-148-8
15096-52-3
STOT RE 1; Acute Tox. 4
trisodium N, N-bis(carboxymethyl)-3-amino-2-hydroxypropionate
TRILON(R) ES 9910
414-130-4
119710-96-2
Acute Tox. 4
trisodium N, N-bis(carboxymethyl)-β-alanine
TRILON(R) ES 9851
414-070-9
129050-62-0
Skin Corr. 1B
trisodium N-(3-propionato)-l-aspartate
422-090-4
172737-80-3
Eye Dam. 1
trisodium nitrilotriacetate
225-768-6
5064-31-3
Carc. 2; Acute Tox. 4; Eye Irrit. 2
trisodium(2-(α-(3-(4-chloro-6-(2-(2-(vinylsulfonyl)ethoxy)ethylamino)-1,3,5-triazin-2-ylamino)-2-oxido-5-sulfonatophenylazo)benzylidenehydrazino)-4-sulfonatobenzoato)copper(II)
REACTIVE BLUE 245
407-580-8
130201-51-3
Eye Dam. 1
tritosulfuron (ISO) (containing ≤0,02 % AMTT); 1-[4-methoxy-6-(trifluoromethyl)-1,3,5-triazin-2-yl]-3-[2-(trifluoromethyl)benzenesulfonyl]urea (containing ≤ 0,02 % AMTT)
604-291-0
142469-14-5
Skin Sens. 1
trixylyl phosphate
246-677-8
25155-23-1
Repr. 1B
yes
trizinc diphosphide; zinc phosphide
215-244-5
1314-84-7
Water-react. 1; Acute Tox. 2
troclosene potassium
218-828-8
2244-21-5
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
troclosene sodium
220-767-7
2893-78-9
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
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