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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 10 May 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
poly-[((4-((4-(ethyl-ethylene)amino)phenyl)-(4-(ethyl-(2-oxyethylene)amino)phenyl)methinyl)-3-methylcyclohexa-2,5-dienylidene)-N-ethyl-N-(2-hydroxyethyl)ammonium acetate]
427-480-8
176429-22-4
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
5-chloro-1,3-dihydro-2H-indol-2-one
CP-13,853
412-200-9
17630-75-0
Repr. 2; Acute Tox. 4; Skin Sens. 1
perfluorooctane sulfonic acid; heptadecafluorooctane-1-sulfonic acid
217-179-8
1763-23-1
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
bensultap (ISO); 1,3-bis(phenylsulfonylthio)-2-(N,N-dimethylamino)propane
605-769-1
17606-31-4
Acute Tox. 4
lead(II) methanesulphonate
BLEIMETHANSULFONAT; LEAD (II) METHANESULFONATE; LEAD METHANE SULPHONATE; LEAD SALT FP
401-750-5
17570-76-2
Repr. 1A; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
yes
1,3-bis(2,3-epoxypropoxy)-2,2-dimethylpropane
241-536-7
17557-23-2
Skin Irrit. 2; Skin Sens. 1
silthiofam (ISO); N-allyl-4,5-dimethyl-2-(trimethylsilyl)thiophene-3-carboxamide
605-752-9
175217-20-6
STOT RE 2
pyraclostrobin (ISO); methyl N-{2-[1-(4-chlorophenyl)-1H-pyrazol-3-yloxymethyl]phenyl}(N-methoxy)carbamate
605-747-1
175013-18-0
Acute Tox. 3; Skin Irrit. 2
monolinuron (ISO); 3-(4-chlorophenyl)-1-methoxy-1-methylurea
217-129-5
1746-81-2
Acute Tox. 4; STOT RE 2
reaction mass of: tetradecanoic acid (42,5-47,5 %); poly(1-7)lactate esters of tetradecanoic acid (52,5-57,5 %)
PRIAZUL MYRISTOYL LACTYLATE; PRICARE MYRISTYL LACTYLATE (1:1.5)
412-580-6
174591-51-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
2,6-bis-(2-(4-(4-amino-phenylamino)-phenylazo)-1,3-dimethyl-3H-imidazolium)-4-dimethylamino-1,3,5-triazine, dichloride
VIOLETT MIP 3250
424-120-1
174514-06-8
Eye Dam. 1
potassium 4-(11-methacrylamidoundecanamido)benzenesulfonate
V67282
406-500-9
174393-75-0
Skin Sens. 1
p-(1-methyloctyl)phenol
241-427-4
17404-66-9
yes
reaction mass of: tris(3,5,5-trimethylhexylammonium) 4-amino-3-(4-(4-(2-amino-4-hydroxyphenylazo)anilino)-3-sulfonatophenylazo)-5,6-dihydro-5-oxo-6-phenylhydrazononaphthalene-2,7-disulfonate; tris(3,5,5-trimethylhexylammonium) 4-amino-3-(4-(4-(4-amino-2-hydroxyphenylazo)anilino)-3-sulfonatophenylazo)-5,6-dihydro-5-oxo-6-phenylhydrazononaphthalene-2,7-disulfonate (2:1)
C.I. DIRECT BLACK 184; C.I. DIRECT NOIR 184
406-000-0
173939-66-7
Eye Dam. 1
methyl (R)-lactate
241-420-6
17392-83-5
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
1,2-dimethylimidazole
217-101-2
1739-84-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
indoxacarb (ISO); methyl (4aS)-7-chloro-2-{(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]carbamoyl}-2,5-dihydroindeno[1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate
605-683-4
173584-44-6
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 1B
1,4-bis[(vinyloxy)methyl]cyclohexane
RAPICURE CHVE
413-370-7
17351-75-6
Skin Sens. 1
N, N,N',N'-tetramethyldithiobis(ethylene)diamine dihydrochloride
AF-172; FPC 114
405-300-9
17339-60-5
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
4-benzyl-2,6-dihydroxy-4-aza-heptylene bis (2,2-dimethyloctanoate)
VMZ95005
418-100-1
172964-15-7
Skin Sens. 1
1-amino-4-(3-[4-chloro-6-(2,5-di-sulfophenylamino)-1,3,5-triazin-2-ylamino]-2,2-dimethyl-propylamino)-anthraquinone-2-sulfonic acid, sodium/lithium salt
BLAU MUB 557
419-520-8
172890-93-6
Skin Sens. 1
trisodium N-(3-propionato)-l-aspartate
422-090-4
172737-80-3
Eye Dam. 1
pentasodium 7-(4-(4-(3-(2-sulfatoethanesulfonyl)phenylamino)-6-(4-(2-sulfatoethanesulfonyl)phenylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate
436-920-8
172399-10-9
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
(1S-cis)-4-(2-amino-6-chloro-9H-purin-9-yl)-2-cyclopentene-1-methanol hydrochloride
426-200-1
172015-79-1
STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
1-aminocyclopentanecarboxamide
422-950-9
17193-28-1
STOT RE 1; Acute Tox. 4; Eye Dam. 1
N-(2-amino-4,6-dichloropyrimidin-5-yl)formamide
425-650-6
171887-03-9
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
reaction mass of: 2,2'-[[cis-1,2-cyclohexanediylbis(nitrilomethylidene)]bis[phenolate]](2-)N, N',O, O'-copper complex;2,2'-[[trans-1,2-cyclohexanediylbis(nitrilomethylidyne)]bis[phenolate]](2-)N, N',O, O'-copper complex
419-610-7
171866-24-3
STOT RE 2
phosphoric acid, calcium nickel salt
-
17169-61-8
Carc. 1A; STOT RE 1; Resp. Sens. 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
edifenphos (ISO); O-ethyl S, S-diphenyl phosphorodithioate
241-178-1
17109-49-8
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
4-oxo-4-(p-tolyl)butyric acid adduct with 4-ethylmorpholine
419-240-6
171054-89-0
Eye Dam. 1
m-mentha-1,3(8)-diene
PRODUCT 5899
404-150-1
17092-80-7
Skin Irrit. 2
isostearic acid monoisopropanolamide
431-540-9
170573-32-7
Skin Irrit. 2
demeton-S-methylsulphon(ISO); S-2-ethylsulphonylethyl dimethyl phosphorothioate
241-109-5
17040-19-6
Acute Tox. 3; Acute Tox. 4
N-[(benzotriazole-1-yl)methyl)]4-carboxy-benzenesulfonamide
BTAD
416-470-9
170292-97-4
Eye Irrit. 2
2-phthalimidoethyl N-[4-(2-cyano-4-nitrophenylazo)phenyl]-N-methyl-β-alaninate
426-400-9
170222-39-6
Skin Sens. 1
clopyralid (ISO); 3,6-dichloropyridine-2-carboxylic acid
216-935-4
1702-17-6
Eye Dam. 1
cadmiumhexafluorosilicate(2-); cadmium fluorosilica
241-084-0
17010-21-8
Acute Tox. 3; Carc. 2; STOT RE 2
reaction mass of: 4,7-bis(mercaptomethyl)-3,6,9-trithia-1,11-undecanedithiol; 4,8-bis(mercaptomethyl)-3,6,9-trithia-1,11-undecanedithiol; 5,7-bis(mercaptomethyl)-3,6,9-trithia-1,11-undecanedithiol
427-050-1
170016-25-8
Repr. 2; Skin Irrit. 2; Skin Sens. 1
salt of: (1S-cis)-1-amino-2,3-dihydro-1H-inden-2-ol and [R-[R*R*]]-2,3-dihydroxybutanedioic acid
425-210-3
169939-84-8
Skin Sens. 1
chloridazon (ISO); 5-amino-4-chloro-2-phenylpyridazine-3-(2H)-one; pyrazon
216-920-2
1698-60-8
Skin Sens. 1
fluorosilicic acid ... %
241-034-8
16961-83-4
Skin Corr. 1B
magnesium hexafluorosilicate
241-022-2
16949-65-8
Acute Tox. 3
hexachloroplatinic acid
241-010-7
16941-12-1
Acute Tox. 3; Skin Corr. 1B; 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
benzyl violet 4B; α-[4-(4-dimethylamino-α-{4-[ethyl(3-sodiosulphonato benzyl)amino] phenyl}benzylidene)cyclohexa-2,5-dienylidene(ethyl)ammonio]toluene-3-sulphonate
216-901-9
1694-09-3
Carc. 2
2,2,4-trimethylhexamethylene-1,6-di-isocyanate
241-001-8
16938-22-0
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
disodium hexachloroplatinate
240-983-5
16923-58-3
Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
dipotassium hexachloroplatinate
240-979-3
16921-30-5
Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
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