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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 25 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
2-(octylthio)ethanol; 2-hydroxyethyl octyl sulphide
222-598-4
3547-33-9
Eye Dam. 1
2-[2-(2-butoxyethoxy)ethoxy]ethanol; TEGBE; triethylene glycol monobutylether; butoxytriethylene glycol
205-592-6
143-22-6
Eye Dam. 1
2-[3-(methylamino)propyl]-1H-benzimidazole
425-760-4
64137-52-6
Eye Dam. 1
2-amino-4-bromo-5-chlorobenzoic acid
ACIDE CÉBRANILIQUE
424-700-4
150812-32-1
Eye Dam. 1
2-chloro-4-(methylsulfonyl)benzoic acid
2-CHLOR-4-METHYLSULFONYLBENZOESÄURE; CMSBA
406-520-8
53250-83-2
Eye Dam. 1
2-ethylhexane-1,3-diol; octylene glycol; ethoexadiol
202-377-9
94-96-2
Eye Dam. 1
2-phenyl-1,3-propanediol
1,3-PPD
411-810-2
1570-95-2
Eye Dam. 1
2-{4-[4-[4-fluoro-6-(2-(2-vinylsulfonylethoxy)ethylamino)-1,3,5-triazin-2-ylamino]phenylazophenylazo}naphthalene-4,6,8-trisulfonate, trisodium salt
442-230-8
321679-52-1
Eye Dam. 1
3,10-diamino-6,13-dichloro-2-((6-(((4-(1,1-dimethylethyl)phenyl)sulfonyl)amino)-2-naphthalenyl)sulfonyl)-4,11-triphenodioxazinedisulfonic acid, lithium potassium sodium salt
440-770-9
371921-63-0
Eye Dam. 1
3-((C12-18)-acylamino)-N-(2-((2-hydroxyethyl)amino)-2-oxoethyl)-N,N-dimethyl-1-propanaminium chloride
427-370-1
164288-56-6
Eye Dam. 1
3-(2,4-bis(4-((5-(4,6-bis(2-aminopropylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-disulfonaphthalen-3-yl)azo)phenylamino)-1,3,5-triazin-6-ylamino)propyldiethylammonium lactate
BLUE PE 3811
424-310-4
178452-66-9
Eye Dam. 1
3-(2-ethylhexyloxy)propane-1,2-diol
2-EHOPD; EHOPD; GE-EH; SENSIVA SC 50
408-080-2
70445-33-9
Eye Dam. 1
3-(2H-tetrazol-5-yl)pyridine
5-(3-PYRIDYL)-TETRAZOL
426-810-8
3250-74-6
Eye Dam. 1
3-(dimethylamino)propylurea
3-(DIMETHYLAMINO)PROPYL UREA; HST 2844
401-950-2
31506-43-1
Eye Dam. 1
3-(hydroxyphenylphosphinyl)propanoic acid
FYROL 3-HPP; HIRETAR-205; PHOSGARD PF 100
411-200-6
14657-64-8
Eye Dam. 1
4,4'-(oxy-(bismethylene))-bis-1,3-dioxolane
DIGLYCERINDIFORMAL (DGDF)
423-230-7
56552-15-9
Eye Dam. 1
4,4'-thiodi-o-cresol
HMPSC
403-330-7
24197-34-0
Eye Dam. 1
4-[2-(1-methyl-2-(4-morpholinyl)ethoxy)ethyl]morpholine
M.E.M.P.E.
407-940-4
111681-72-2
Eye Dam. 1
4-cyclohexyl-2-methyl-2-butanol
CORANOL
420-630-3
83926-73-2
Eye Dam. 1
4-oxo-4-(p-tolyl)butyric acid adduct with 4-ethylmorpholine
419-240-6
171054-89-0
Eye Dam. 1
5-[[4-chloro-6-[[2-[[4-fluoro-6-[[5-hydroxy-6-[(4-methoxy-2-sulfophenyl)azo]-7-sulfo-2-naphthalenyl]amino]-1,3,5-triazin-2-yl]amino]-1-methylethyl]amino]-1,3,5-triazin-2-yl]amino]-3-[[4-(ethenylsulfonyl)phenyl]azo]-4-hydroxy-naphtalene-2,7-disulfonic acid, sodium salt
ROUGE REACTIF REN 208
418-380-5
168113-78-8
Eye Dam. 1
5-chloro-2-(4-chlorophenoxy)phenol
429-290-0
3380-30-1
Eye Dam. 1
5-methylpyrazine-2-carboxylic acid
5-METHYLPYRAZINE-2-CARBOXYLIC ACID; ACIDO 5-METILPIRAZIN CARBOSSILICO
413-260-9
5521-55-1
Eye Dam. 1
5-thiazolylmethanol
A-87440.0; A-87440.00
414-780-9
38585-74-9
Eye Dam. 1
5-{4-[5-amino-2-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-sulfo-phenylamino]-6-chloro-1,3,5-triazin-2-ylamino}-4-hydroxy-3-(1-sulfo-naphthalen-2-ylazo)-naphthalene-2,7-disulfonicacid sodium salt
ROUGE TZ 4075
418-340-7
157707-94-3
Eye Dam. 1
6,13-dichloro-3,10-bis{2-[4-fluoro-6-(2-sulfophenylamino)-1,3,5-triazin-2-ylamino]propylamino}benzo[5,6][1,4]oxazino[2,3-.b.]phenoxazine-4,11-disulphonic acid, lithium-, sodium salt
BLEU REN 20
418-000-8
163062-28-0
Eye Dam. 1
7-amino-4-hydroxy-2-naphthalenesulfonic acid, coupled with 5 (or 8) -amino-8 (or 5)-[[4-[[4-[[4-amino-6(or 7)-sulfo-1-naphthyl]azo]phenyl]amino]-3-sulfophenyl]azo]-2-naphthalenesulfonic acid and 4-hydroxy-7-(phenylamino)-2-naphthalenesulfonic acid, sodium salt
424-850-0
189702-72-5
Eye Dam. 1
[(1-methyl-1,2-ethanediyl)bis[nitrilobis(methylene)]]tetrakis(phosphonic acid)
421-940-1
28698-31-9
Eye Dam. 1
[1R-(1-α, 2β,5α)]-mono[5-methyl-2-(1-methylethyl)cyclohexyl]butanedioate
426-890-4
77341-67-4
Eye Dam. 1
[phosphinyldynetris(oxy)] tris[3-aminopropyl-2-hydroxy-N, N-dimethyl-N-(C6-18)-alkyl] trichlorides
425-520-9
197179-61-6
Eye Dam. 1
A reaction mass of: (1,3-dioxo-2H-benz(de)isoquinolin-2-ylpropyl)hexadecyldimethylammonium 4-toluenesulfonate; (1,3-dioxo-2H-benz(de)isoquinolin-2-ylpropyl)hexadecyldimethylammonium bromide
CCA-VERSUCHSPRODUKT SN 4001
405-080-4
118725-24-9
Eye Dam. 1
benzyl [hydroxy-(4-phenylbutyl)phosphinyl] acetate
SQ 28,355; SQ 28355
416-050-5
87460-09-1
Eye Dam. 1
bis(3-(trimethoxysilyl)propyl)amine
280-084-5
82985-35-1
Eye Dam. 1
bis[[2,2',2''-nitrilotris-[ethanolato]]-1-N,O]-bis[2-(2-methoxyethoxy)ethoxy]-titanium
TITANCHELAT ETAM
410-500-4
357921-97-2
Eye Dam. 1
C12-14-tert-alkyl ammonium 1-amino-9,10-dihydro-9,10-dioxo-4-(2,4,6-trimethylanilino)-anthracen-2-sulfonate
ORASOL BLAU 761B
414-110-5
1379678-96-2
Eye Dam. 1
clopyralid (ISO); 3,6-dichloropyridine-2-carboxylic acid
216-935-4
1702-17-6
Eye Dam. 1
dimethyldioctadecylammonium chloride; DODMAC
203-508-2
107-64-2
Eye Dam. 1
diphenoxymethylenecyanamide
427-300-8
79463-77-7
Eye Dam. 1
disodium (E)-1,2-bis-(4-(4-methylamino-6-(4-methylcarbamoylphenylamino)-1,3,5-triazin-2-ylamino)phenyl-2-sulfonato)ethene
427-310-2
180850-95-7
Eye Dam. 1
disodium 1-amino-4-(4-benzenesulphonamido-3-sulphonatoanilino)anthraquinone-2-sulphonate
ACID BLUE 344; BLEU ACIDE 344; BLEU ACIDO 344; BLU ACIDO 344; C.I. ACID BLUE 344; SÄURE BLAU 344
400-350-8
85153-93-1
Eye Dam. 1
disodium 2-(5-carbamoyl-1-ethyl-2-hydroxy-4-methyl-6-oxo-1,6-dihydro-pyridine-3-ylazo)-4-(4-fluoro-6-(4-(2-sulfonyloxy-ethylsulfonyl)-phenylamino)-1,3,5-triazine-2-ylamino)benzene sulfonate
432-980-4
243858-60-8
Eye Dam. 1
disodium 3,3'-[iminobis[sulfonyl-4,1-phenylene-(5-hydroxy-3-methylpyrazole-1,4-diyl)azo-4,1-phenylenesulfonylimino-(4-amino-6-hydroxypyrimidine-2,5-diyl)azo-4,1-phenylenesulfonylimino(4-amino-6-hydroxypyrimidine-2,5-diyl)azo]bis(benzenesulfonate)]
YELLOW JB 1238
423-110-4
-
Eye Dam. 1
disodium 7-[4-chloro-6-(N-ethyl-o-toluidino)-1,3,5-triazin2-ylamino]-4-hydroxy-3-(4-methoxy-2-sulfonatophenylazo)2-naphthalenesulfonate
SCARLET X-GA 1491
410-390-8
147703-64-8
Eye Dam. 1
disodium 8-amino-5-{4-[2-(sulfonatoethoxy)sulfonyl]phenylazo}naphthalene-2-sulfonate
423-730-5
250688-43-8
Eye Dam. 1
disodium N-carboxymethyl-N-(2-(2-hydroxyethoxy)ethyl)glycinate
DIDA
402-360-8
92511-22-3
Eye Dam. 1
ethyl 2-ethoxy-4-carboxymethylbenzoate
ECPA
427-630-2
99469-99-5
Eye Dam. 1
ethyl N2-dodecanoyl-l-argininate hydrochloride
434-630-6
60372-77-2
Eye Dam. 1
fosetyl-aluminium (ISO); aluminium triethyl triphosphonate
254-320-2
39148-24-8
Eye Dam. 1
glyphosate (ISO); N-(phosphonomethyl)glycine
213-997-4
1071-83-6
Eye Dam. 1
glyphosine (ISO); N,N-bis(phosphonomethyl)glycine
219-468-4
2439-99-8
Eye Dam. 1
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