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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
tetrachlorophthalic anhydride
204-171-4
117-08-8
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
tetrahydro-4-methylphthalicanhydride
251-823-9
34090-76-1
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
tetrahydromethylphthalicanhydride
234-290-7
11070-44-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
tetrahydrophthalic anhydride
247-570-9
26266-63-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
trans-cyclohexane-1,2-dicarboxylic anhydride
238-009-9
14166-21-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
(3'-carboxymethyl-5-(2-(3-ethyl-3H-benzothiazol-2-ylidene)-1-methyl-ethylidene)-4,4'-dioxo-2'-thioxo-(2,5')bithiazolidinyliden-3-yl)-acetic acid
CIN 10094329; SENSIBILISATOR KF 693 PINA; SENSITIZER KF 693 PINA
422-240-9
166596-68-5
Eye Dam. 1; Skin Sens. 1
(4-aminophenyl)-N-methylmethylensulfonamide hydrochloride
SULPHONAMIDO-ANILINE
406-010-5
88918-84-7
Eye Dam. 1; Skin Sens. 1
1-((2-quinolinyl-carbonyl)oxy)-2,5-pyrrolidinedione
PTH-SUCCINIMIDESTER
418-630-3
136465-99-1
Eye Dam. 1; Skin Sens. 1
1-(2-hydroxyethyl)-1H-pyrazol-4,5-diyldiammoniumsulfate
PYRAZOL P5; PYRAZOLE DHE
429-300-3
155601-30-2
Eye Dam. 1; Skin Sens. 1
1-amino-4-[(4-amino-2-sulfofenyl)amino]-9,10-dihydro-9,10-dioxo-2-anthracenesulfonic acid, disodium salt, reaction products with 2-[[3-[(4,6-dichloro-1,3,5-triazin-2-yl)ethylamino]phenyl]sulfonyl]ethyl hydrogen sulfate, sodium salts
451-430-4
500717-36-2
Eye Dam. 1; Skin Sens. 1
2-((4-amino-2-nitrophenyl)amino)benzoic acid
RO 1082
411-260-3
117907-43-4
Eye Dam. 1; Skin Sens. 1
2-(para-chlorophenyl)glycineamide
420-830-0
102333-75-5
Eye Dam. 1; Skin Sens. 1
2-[[4[[4,6-bis[[3-(diethylamino)propyl]amino]-1,3,5-triazine-2-yl]amino]phenyl]azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutanamide
KAYACEL YELLOW CG; NO.466 BZN
407-680-1
98809-11-1
Eye Dam. 1; Skin Sens. 1
2-chloro-N-(4-methylphenyl)acetamide
435-170-9
16634-82-5
Eye Dam. 1; Skin Sens. 1
2-methyl-5-(1,1,3,3-tetramethylbutyl)hydroquinone
AF-336
400-530-6
723-38-6
Eye Dam. 1; Skin Sens. 1
3-amino-4-hydroxy-N-(2-methoxyethyl)-benzenesulfonamide
FAT 92.346 B
411-520-6
112195-27-4
Eye Dam. 1; Skin Sens. 1
4-[4-amino-5-hydroxy-3-(4-(2-sulfoxyethylsulfonyl)phenylazo)-2,7-disulfonapht-6-ylazo]-6-[3-(4-amino-5-hydroxy-3-(4-(2-sulfoxyethylsulfonyl)phenylazo)-2,7-disulfonapht-6-ylazo]phenylcarbonylamino]benzenesulfonic acid, sodium salt
NAVY DER 7850
417-640-5
161935-19-9
Eye Dam. 1; Skin Sens. 1
4-amino-3-[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-1-naphthalene sulfonic acid
427-680-5
188907-52-0
Eye Dam. 1; Skin Sens. 1
4-hydroxy-7-(2-aminoethyl)-1,3-benzothiazol-2(3H)-one hydrochloride
432-470-1
189012-93-9
Eye Dam. 1; Skin Sens. 1
5-(4-[4-[4-(3,5-dicarboxy-phenyl-azo)phenylamino]-6-morpholin-4-yl-1,3,5-triazin-2-ylamino]phenylazo)isophthalic acid, mixed monosodium and diammonium salt
414-410-6
1379676-83-1
Eye Dam. 1; Skin Sens. 1
[R-(R*,S*)]-[[2-methyl-1-(1-oxopropoxy)propoxy]-(4-phenylbutyl)phosphinyl] acetic acid, (-)-cinchonidine (1:1) salt
SQ 28,796
415-820-8
137590-32-0
Eye Dam. 1; Skin Sens. 1
behenamidopropyl-dimethyl-(dihydroxypropyl) ammonium chloride
LEXQUAT AMG-BEO (CONCENTRATE)
423-420-1
136920-10-0
Eye Dam. 1; Skin Sens. 1
bis(dimethyl-(2-hydroxyethyl)ammonium) 1,2-ethanediyl-bis(2-hexadecenylsuccinate)
Z-27
421-660-1
-
Eye Dam. 1; Skin Sens. 1
cis-1-amino-2,3-dihydro-1H-inden-2-ol
422-660-2
7480-35-5
Eye Dam. 1; Skin Sens. 1
disodium 5-[5-[4-(5-chloro-2,6-difluoropyrimidin-4-ylamino)benzamido]-2-sulfonatophenylazo]-1-ethyl-6-hydroxy-4-methyl-2-oxo-3-pyridylmethylsulfonate
YELLOW DO 2286
412-530-3
157627-98-0
Eye Dam. 1; Skin Sens. 1
ethyl 2-(3-nitrobenzylidene)acetoacetate
3-NITROBENZYLIDENETHYLESTER
404-490-0
39562-16-8
Eye Dam. 1; Skin Sens. 1
hafnium tetra-n-butoxide
TILCOM HTB
411-740-2
22411-22-9
Eye Dam. 1; Skin Sens. 1
hexasodium (di[N-(3-(4-[5-(5-amino-3-methyl-1-phenylpyrazol-4-yl-azo)-2,4-disulfo-anilino]-6-chloro-1,3,5-triazin-2-ylamino)phenyl)-sulfamoyl](di-sulfo)-phthalocyaninato)nickel
PROCION EMERALD H-EXL COLOUR; SUBSTANCE S156718
417-250-5
151436-99-6
Eye Dam. 1; Skin Sens. 1
lithium 1-amino-4-(4-tert-butylanilino)anthraquinone-2-sulfonate
BLUE 14 52 200
411-140-0
125328-86-1
Eye Dam. 1; Skin Sens. 1
lithium sodium 4,4', 4''-(nitrilotris(ethane-2,1-diylimino(6-chloro-1,3,5-triazine-4,2-diyl)imino))tris(5-hydroxy-6-(1-sulfonaphthalene-2-ylazo)-2,7-naphthalene)disulfonate
429-730-1
193562-37-7
Eye Dam. 1; Skin Sens. 1
methyl 2R,3S-(-)-3-(4-methoxyphenyl)oxiranecarboxylate
MEFAT
404-130-2
105560-93-8
Eye Dam. 1; Skin Sens. 1
N, N'-bis(trifluoroacetyl)-S, S'-bis-L-homocysteine
BMS 208143-01; BTHC
429-670-6
105996-54-1
Eye Dam. 1; Skin Sens. 1
N, N'-ethylenebis(vinylsulfonylacetamide)
H-603
404-790-1
66710-66-5
Eye Dam. 1; Skin Sens. 1
N,N'-bis{6-chloro-4-[6-(4-vinylsulfonylphenylazo)-2,7-disulfonicacid-5-hydroxynapht-4-ylamino]-1,3,5-triazin-2-yl}-N-(2-hydroxyethyl)ethane-1,2-diamine, sodium salt
RED REN 363
419-500-9
171599-85-2
Eye Dam. 1; Skin Sens. 1
N-[1-(S)-ethoxycarbonyl-3-phenylpropyl]-L-alanyl-N-carboxyanhydride
430-360-8
84793-24-8
Eye Dam. 1; Skin Sens. 1
N-[2-hydroxy-3-(C12-16-alkyloxy)propyl]-N-methyl glycinate
DS 100
415-060-7
1379678-87-1
Eye Dam. 1; Skin Sens. 1
N-dodecyl-[3-(4-(dimethylamino)benzamido)-propyl]dimethylammonium tosylate
DIMETHYLPAPAMIDOLAURDIMONIUM TOSYLATE
421-130-8
156679-41-3
Eye Dam. 1; Skin Sens. 1
octasodium 2-(6-(4-chloro-6-(3-(N-methyl-N-(4-chloro-6-(3,5-disulfonato-2-naphthylazo)-1-hydroxy-6-naphthylamino)-1,3,5-triazin-2-yl)aminomethyl)phenylamino)-1,3,5-triazin-2-ylamino)-3,5-disulfonato-1-hydroxy-2-naphthylazo)naphthalene-1,5-disulfonate
PROCION BRILLIANT ORANGE H-EXL; S156745
412-960-1
148878-21-1
Eye Dam. 1; Skin Sens. 1
oxo-((2,2,6,6-tetramethylpiperidin-4-yl)amino)carbonylacetohydrazide
LUCHEM HA-R 100; LUPERSOL HA-R 100
413-230-5
122035-71-6
Eye Dam. 1; Skin Sens. 1
pentasodium 4-amino-6-(5-(4-(2-ethyl-phenylamino)-6-(2-sulfatoethanesulfonyl)-1,3,5-triazin-2-ylamino)-2-sulfonatophenylazo)-5-hydroxy-3-(4-(2-sulfatoethanesulfonyl)phenylazo)naphthalene-2,7-disulfonate
REACTIVE NAVY BLUE 9411; SUMIFIX SUPRA MARINE BNF GRANULES
423-790-2
1379676-74-0
Eye Dam. 1; Skin Sens. 1
pentasodium monohydrogen 6-chloro-3,10-bis[2-[4-chloro-6-(2,4-disulfophenylamino)-1,3,5-triazin-2-yl-amino]ethylamino]-13-ethylbenzo[5.6][1.4]oxazino[2,3-b]phenoxazine-4,11-disulfonate
414-910-4
-
Eye Dam. 1; Skin Sens. 1
reaction mass of isomers of: sodium phenethylnaphthalenesulfonate; sodium naphthylethylbenzenesulfonate
UNISOL S
405-760-0
-
Eye Dam. 1; Skin Sens. 1
reaction mass of: 2,2,6,6-tetramethylpiperidin-4-yl-hexadecanoate; 2,2,6,6-tetramethylpiperidin-4-yl-octadecanoate
CYASORB UV-3853 LIGHT STABILIZER; DASTIB 845; SANDUVOR 845
415-430-8
86403-32-9
Eye Dam. 1; Skin Sens. 1
reaction mass of: 2-methylnonanedioic acid; 2,4-dimethyl-4-methoxycarbonylundecanedioic acid; 2,4,6-trimethyl-4,6-dimethoxycarbonyltridecanedioic acid; 8,9-dimethyl-8,9-dimethoxycarbonylhexadecanedioic acid
MMA-10R
423-670-1
-
Eye Dam. 1; Skin Sens. 1
reaction mass of: 3-[3-carbamoyl-5-(5-{4-chloro-6[4-(2-sulfonatooxyethylsulfonyl)anilino]-1,3,5-triazin-2-ylamino}-2-sulfonatophenylazo)-1,2-dihydro-6-hydroxy-4-methyl-2-oxo-1-pyridyl]propanoic acid, trisodium salt; 3-[3-carbamoyl-5-(5-{4-chloro-6-[4-(vinylsulfonyl)anilino]-1,3,5-triazin-2-ylamino}-2-sulfonatophenylazo)-1,2-dihydro-6-hydroxy-4-methyl-2oxo-1-pyridyl]propanoicacid, disodium salt
440-510-4
-
Eye Dam. 1; Skin Sens. 1
reaction mass of: carbonato-bis-N-ethyl-2-isopropyl-1,3-oxazolidine; methyl carbonato-N-ethyl-2-isopropyl-1,3-oxazolidine; 2-isopropyl-N-hydroxyethyl 1,3-oxazolidine
429-990-6
-
Eye Dam. 1; Skin Sens. 1
reaction mass of: cis-(5-ammonium-1,3,3-trimethyl)-cyclohexanemethylammonium phosphate (1:1); trans-(5-ammonium-1,3,3-trimethyl)-cyclohexanemethylammonium phosphate (1:1)
VESTAGON EP S 270
411-830-1
114765-88-7
Eye Dam. 1; Skin Sens. 1
reaction mass of: N-aminoethylpiperazonium mono-2,4,6-trimethylnonyldiphenyl ether di-sulfonate; N-aminoethylpiperazonium di-2,4,6-trimethylnonyldiphenyl ether di-sulfonate
COMPLEXING AGENT BN
410-650-0
-
Eye Dam. 1; Skin Sens. 1
reaction mass of: pentasodium bis[6-anilino-3,5'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato]cobaltate(III); tetrasodium [6-anilino-3,5'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato][6-anilino-5'-sulfamoyl-3-sulfonatonaphthalene-2-azobenzene-1,2'-diolato]cobaltate(III); trisodium bis[6-anilino-5'-sulfamoyl-3-sulfonatonaphthalene-2-azobenzene-1,2'-diolato]cobaltate(III)
444-290-0
508202-43-5
Eye Dam. 1; Skin Sens. 1
reaction mass of: pentasodium; 2-[[8-[[4-chloro-6-[[4-(2-sulfonatethylsulfonyl)]phenyl]amino]-1,3,5-triazin-2-yl]amino-1-hydroxy-3,6-disulfonato-2-naphthalenyl]azo]naphthalene-1,5-disulfonate; 2-[[8-[[4-chloro-6-[[4-[[2-ethenyl]sulfonyl]phenyl]amino]1,3,5-triazin-2-yl]amino]-1-hydroxy-3,6-disulfonato-2-naphthalenyl]azo]naphthalene-1,5-disulfonate
450-010-8
-
Eye Dam. 1; Skin Sens. 1
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