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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 30 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
reaction mass of: trisodium 2-(2-[α-(2-carboxylato-κ-O-4-sulfonatophenylazo)benzylidene]hydrazino-κ-N')-6-(2,6-difluoropyrimidin-4-ylamino)-4-sulfonatophenolatocuprate (II); trisodium 2-(2-[α-(2-carboxylato-κ-O-4-sulfonatophenylazo)benzylidene]hydrazino-κ-N')-6-(4,6-difluoropyrimidin-2-ylamino)-4-sulfonatophenolatocuprate (II)
428-260-4
-
Eye Dam. 1
reaction mass of: trisodium 5-(4-fluoro-6-morpholin-4-yl-1,3,5-triazin-2-ylamino)-4-hydroxy-3-(4-(2-sulfooxyethanesulfonyl)phenylazo)naphthalene-2,7-disulfonate; disodium 3-(4-ethenesulfonylphenylazo)-5-(4-fluoro-6-morpholin-4-yl-1,3,5-triazin-2-ylamino)-4-hydroxynaphthalene-2,7-disulfonate
428-400-4
-
Eye Dam. 1
reaction mass of: trisodium 5-{4-chloro-6-[N-ethyl-(3-(2-sulfonatooxy)ethylsulfonyl)aniline]-1,3,5-triazin-2-ylamino}-4-hydroxy-3-[4-(vinylsulfonyl)phenylazo{naphthalene-2,7-disulfonate; trisodium 5-4-chloro-6-[N-ethyl-3-(vinylsulfonyl)anilino]-1,3,5-triazin-2-ylamino}-4-hydroxy-3-[4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo]naphthalene-2,7-disulfonate; disodium 5-4-chloro-6-[N-ethyl-3-(vinylsulfonyl)anilino]-1,3,5-triazin-2-ylamino}-4-hydroxy-3-[(4-vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate; tetrasodium 5-4-chloro-6-[N-ethyl-3-(2-(sulfonatooxy)ethylsulfonyl)anilino]-1,3,5-triazin-2-ylamino}-3-[4(2-(sulfonatooxy)ethylsulfonyl)phenylazo]-4-hydroxynaphthalene-2,7-disulfonate
444-050-5
-
Eye Dam. 1
reaction mass of: trisodium N(1')-N(2):N(1''')-N(2'')-η-6-[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]-6''-(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''-disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'-azobenzene-1,2'-diolato-O(1), O(2'))-chromate; trisodium N(1')-N(2):N(1''')N(2'')-η-6,6''-bis(1-carbaniloyl-2-hydroxyprop-1-enylazo)-5',5'''disulfamoyl-3,3''-disulfonato; bis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate; trisodium N(1')-N(2):N(1''')N(2'')-η-6,6''-bis[2-amino-4-(or 6)-hydroxy-(or 4-amino-2-hydroxy)phenylazo]5',5'''disulfamoyl-3,3''-disulfonatobis(naphthalene-2,1'azobenzene-1,2'-diolato-O(1),O(2'))-chromate (2:1:1)
NOIR SANDODERM HH 1050; SANDODERM BLACK HH 1050; SANDODERM BLACK R; SANDODERM BLACK R CONC.; SANDODERM SCHWARZ R; SANDODERM SCHWARZ R KONZ.
402-850-1
-
Eye Dam. 1
reaction mass of:1-deoxy-1-[methyl-(1-oxohexadecyl)amino]-D-glucitol; 1-deoxy-1-[methyl-(1-oxooctadecyl)amino]-D-glucitol
GA161895; GLUCAMIDE
411-130-6
-
Eye Dam. 1
reaction product of: 2-[[4-amino-2-ureidophenylazo]-5-[(2-(sulfooxy)ethyl)sulfonyl]]benzenesulfonic acid with 2,4,6-trifluoropyrimidine and partial hydrolysis to the corresponding vinylsulfonyl derivative, mixed potassium/sodium salt
YELLOW MGI 1301
424-250-9
-
Eye Dam. 1
reaction product of: C.I. Leuco Sulfur Black 1 with (3-chloro-2-hydroxypropyl)trimethylammonium chloride
424-510-1
-
Eye Dam. 1
reaction product of: copper, (29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32)-, chlorosulfuric acid and 3-(2-sulfooxyethylsulfonyl)aniline, sodium salts
PRODUKT 1245
420-980-7
-
Eye Dam. 1
reaction products of 3,10-bis((2-aminopropyl)amino)-6,13-dichloro-4,11-triphenodioxazinedisulfonic acid with 2-amino-1,4-benzenedisulfonic acid, 2-((4-aminophenyl)sulfonyl)ethyl hydrogen sulfate and 2,4,6-trifluoro-1,3,5-triazine, sodium salts
426-860-0
191877-09-5
Eye Dam. 1
sodium ((N-(3-trimethylammoniopropyl)sulfamoyl)methylsulfonatophthalocyaninato)copper(II)
C.I. BASIC BLUE 163
407-340-2
124719-24-0
Eye Dam. 1
sodium 2-anilino-5-(2-nitro-4-(N-phenylsulfamoyl))anilinobenzenesulfonate
NSGBB; YELLOW BROWN E-GLN
412-320-1
31361-99-6
Eye Dam. 1
sodium 3,5-dichloro-2-(5-cyano-2,6-bis(3-hydroxypropylamino)-4-methylpyridin-3-ylazo)benzenesulphonate
H: SÄUREGELB 2829
401-870-8
115035-41-1
Eye Dam. 1
sodium 3-(2H-benzotriazol-2- yl)-5-sec-butyl-4-hydroxyben zenesulfonate
BENZTRIAZOL UV ABSORBER BUK 4499; BUK 4499; UV ABSORBER BUK 4499
403-080-9
92484-48-5
Eye Dam. 1
sodium hydrogensulphate
231-665-7
7681-38-1
Eye Dam. 1
sodium salt of 4-amino-3,6-bis[[5-[[4-chloro-6-[(2-methyl-4-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulfophenyl]azo]-5-hydroxy-2,7-naphthalenedisulfonic acid
435-350-7
141250-43-3
Eye Dam. 1
tetrasodium 10-amino-6,13-dichloro-3-(3-(4-(2,5-disulfonatoanilino)-6-fluoro-1,3,5-triazin-2-ylamino)prop-3-ylamino)-5,12-dioxa-7,14-diazapentacene-4,11-disulfonate
BLEU DIOXAZINA ST 7005; BLEU DIOXAZINE ST 7005; DIOXAZIN BLAU ST 7005; DIOXAZINE BLUE ST 7005
402-590-9
109125-56-6
Eye Dam. 1
tetrasodium 2-(4-fluoro-6-(methyl-(2-(sulfatoethylsulfonyl)ethyl)amino)-1,3,5-triazin-2-ylamino)-5-hydroxy-6-(4-methyl-2-sulfonatophenylazo)naphthalene-1,7-disulfonate
432-550-6
243858-01-7
Eye Dam. 1
tetrasodium 4,4'-bis{4-[4-(2-hydroxyethylamino)-6-(4-sulfonatoanilino)-1,3,5-triazin-2-ylamino]phenylazo}stilbene-2,2'-disulfonate
429-230-3
371921-41-4
Eye Dam. 1
tetrasodium dihydrogen 1,1''-dihydroxy-8,8''-[p-phenylbis(imino-{6-[4-(2-aminoethyl)piperazin-1-yl]}-1,3,5-triazine-4,2-diyl-imino)]bis(2,2'-azonaphthalene-1',3,6-trisulfonate)
RED ULK 1640
420-350-1
172277-97-3
Eye Dam. 1
titanium(4+) oxalate
TITANYL OXALAAT
403-260-7
31363-92-5
Eye Dam. 1
trans-2-isopropyl-5-carboxy-1,3-dioxane
DHP OPT
445-770-2
42031-28-7
Eye Dam. 1
tris(octadec-9-enylammonium) (trisulfonatophthalocyaninato)copper(II)
PIGMENTBLAU 1755
403-210-4
108300-90-9
Eye Dam. 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 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-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 [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 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 N-(3-propionato)-l-aspartate
422-090-4
172737-80-3
Eye Dam. 1
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
zinc hexacyanocobaltate(III), tertiary butyl alcohol/polypropylene glycol complex
425-240-7
-
Eye Dam. 1
zinc-bis(4-(n-octyloxycarbonylamino)salicylate) dihydrate
417-130-2
1379689-21-0
Eye Dam. 1
N, N''-(methylenedi-4,1-phenylene)bis[N'-octyl]urea
445-760-8
-
Eye Dam. 1; Resp. Sens. 1
(1α,2α,3β,6β)-1,2,3,6-tetrahydro-3,6-methanophthalic anhydride
220-384-5
2746-19-2
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
1,2,3,6-tetrahydro-3,6-methanophthalic anhydride
212-557-9
826-62-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
1,2,3,6-tetrahydro-3-methylphthalic anhydride
226-247-6
5333-84-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
1,2,3,6-tetrahydro-4-methylphthalic anhydride
222-323-8
3425-89-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
1,2,3,6-tetrahydromethylphthalic anhydride
247-830-1
26590-20-5
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
1,2,3,6-tetrahydrophthalic anhydride
201-605-4
85-43-8
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
2,3,5,6-tetrahydro-2-methylphthalic anhydride
255-853-3
42498-58-8
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
3,4,5,6-tetrahydrophthalic anhydride
219-374-3
2426-02-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride
204-957-7
129-64-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
benzene-1,2:4,5-tetracarboxylic dianhydride; benzene-1,2:4,5-tetracarboxylic dianhydride; pyromellitic dianhydride
201-898-9
89-32-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
cis-1,2,3,6-tetrahydro-4-methylphthalic anhydride
216-906-6
1694-82-2
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
cis-1,2,3,6-tetrahydrophthalicanhydride
213-308-7
935-79-5
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
cis-cyclohexane-1,2-dicarboxylicanhydride
236-086-3
13149-00-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
cyclohexane-1,2-dicarboxylic anhydride
201-604-9
85-42-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
hexahydro-1-methylphthalic anhydride
256-356-4
48122-14-1
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
hexahydro-3-methylphthalicanhydride
260-566-1
57110-29-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
hexahydro-4-methylphthalic anhydride
243-072-0
19438-60-9
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
hexahydromethylphthalic anhydride
247-094-1
25550-51-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
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