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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 01 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
3-tridecyloxy-propyl-ammonium 9-octadecenoate
Z-29
418-990-1
778577-53-0
STOT RE 2; Eye Irrit. 2; Skin Irrit. 2
(ethyl-1,2-ethanediyl)[-2-[[[(2-hydroxyethyl)methylamino]acetyl]-propyl]ω-(nonylphenoxy)poly]oxy-(methyl-1,2-ethanediyl)
TFA-4713
418-960-8
-
Skin Corr. 1B; Skin Sens. 1
4,4'-bis(N-carbamoyl-4-methylbenzenesulfonamide)diphenylmethane
B-TUM
418-770-5
151882-81-4
Carc. 2
sodium (n-butyl)x(ethyl)y-1,5-dihydro)aluminate x = 0,5 y =1,5
EURESYNTH(R) 5010
418-720-2
-
Flam. Sol. 1; Water-react. 1; Pyr. Sol. 1; Acute Tox. 4; Skin Corr. 1A
1-((2-quinolinyl-carbonyl)oxy)-2,5-pyrrolidinedione
PTH-SUCCINIMIDESTER
418-630-3
136465-99-1
Eye Dam. 1; Skin Sens. 1
(R)-α-phenylethylammonium(-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate
PHENETHYLAMMONIUM SALT OF FOSFOMYCIN
418-570-8
25383-07-7
Repr. 2
(1R,4S)-2-azabicyclo[2.2.1]hept-5-en-3-one
1418U90
418-530-1
79200-56-9
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
tetra-ammonium 2-[6-[7-(2-carboxylato-phenylazo)-8-hydroxy-3,6-disulfonato-1-naphthylamino]-4-hydroxy-1,3,5-triazin-2-ylamino]benzoate
MJR-580
418-520-5
183130-96-3
Eye Irrit. 2
1-bromo-3,4,5-trifluorobenzene
1-BROM-3,4,5-TRIFLUORBENZOL; 1-BROMO-3,4,5-TRIFLUOROBENZENE
418-480-9
138526-69-9
Flam. Liq. 3; Carc. 2; Skin Irrit. 2; Eye Dam. 1
1-dimethylcarbamoyl-4-(2-sulfonatoethyl)pyridinium
418-440-0
136997-71-2
Skin Sens. 1
sodium 3-(methoxycarbonyl)-4-oxo-3,4,5,6-tetrahydro-2-pyridinolate
418-410-7
139122-78-4
Eye Irrit. 2
methyltriphenylphosphonium chloride
METHYL-TPP-CHLORID; MTPP-CHLORID
418-400-2
1031-15-8
Acute Tox. 4; Skin Irrit. 2; 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
bis(hydrogenated tallow C16-18-alkyl)hydroxylamine
418-370-0
143925-92-2
Skin Sens. 1
hexahydrocyclopenta[c]pyrrole-1-(1H)-ammonium N-ethoxycarbonyl-N-(p-tolylsulfonyl)azanide
AMINAZA TOLFAMATATE
418-350-1
-
Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 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
1-hydroxy-4-fluoro-1,4-diazoniabicyclo[2.2.2]octane bis(tetrafluoroborate)
418-330-2
162241-33-0
Expl. 1.1; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
4-[4-(2-ethylhexyloxy)phenyl](1,4-thiazinane-1,1-dioxide)
CIN 10097929
418-320-8
133467-41-1
Acute Tox. 4
N, N-dibutyl-(2,5-dihydro-5-thioxo-1H-tetrazol-1-yl)acetamide
418-290-6
168612-06-4
Eye Irrit. 2; Skin Sens. 1
2,2-(1,4-phenylene)bis((4H—3,1-benzoxazine-4-one)
CYASORB(R) UV-3638 LIGHT STABILISER
418-280-1
18600-59-4
Skin Sens. 1
pentapotassium 2-(4-(5-[1-(2,5-disulfonatophenyl)-4,5-dihydro-3-methylcarbamoyl-5-oxopyrazol-4-ylidene]-3-methyl-1,3-pentadienyl)-3-methylcarbamoyl-5-oxidopyrazol-1yl)benzene-1,4-disulfonate
418-270-7
-
Skin Sens. 1
potassium 1-methyl-3-morpholinocarbonyl-4-[3-(1-methyl-3-morpholinocarbonyl-5-oxo-2-pyrazolin-4-ylidene)-1-propenyl]pyrazole-5-olate [containing < 0,5 % N, N-dimethylformamide (EC no; 200-679-5)];potassium 1-methyl-3-morpholinocarbonyl-4-[3-(1-methyl-3-morpholinocarbonyl-5-oxo-2-pyrazolin-4-ylidene)-1-propenyl]pyrazole-5-olate [containing ≥ 0,5 % N, N-dimethylformamide (EC No 200-679-5)]
418-260-2
183196-57-8
Skin Sens. 1
potassium 1-methyl-3-morpholinocarbonyl-4-[3-(1-methyl-3-morpholinocarbonyl-5-oxo-2-pyrazolin-4-ylidene)-1-propenyl]pyrazole-5-olate [containing < 0,5 % N, N-dimethylformamide (EC no; 200-679-5)];potassium 1-methyl-3-morpholinocarbonyl-4-[3-(1-methyl-3-morpholinocarbonyl-5-oxo-2-pyrazolin-4-ylidene)-1-propenyl]pyrazole-5-olate [containing ≥ 0,5 % N, N-dimethylformamide (EC No 200-679-5)]
418-260-2
183196-57-8
Repr. 1B; Skin Sens. 1
1-ethyl-1-methylmorpholinium bromide
MEM
418-250-8
65756-41-4
Muta. 2
N-methyl-4-(p-formylstyryl)pyridinium methylsulfate
N-METHYL-4-(P-FORMYLSTYRYL)-PYRIDINIUM METHYLSULFATE; SBQ; SBQ-SALZ
418-240-3
74401-04-0
Skin Sens. 1
reaction mass of: 5-[(4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)azo]-2,5-diethoxyphenyl)azo]-2-[(3-phosphonophenyl)azo]benzoic acid; 5-[(4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)azo]-2,5-diethoxyphenyl)azo]-3-[(3-phosphonophenyl)azo]benzoic acid
BONJET BLACK 817
418-230-9
163879-69-4
Expl. 1.3; Repr. 2; STOT RE 2; Skin Sens. 1
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
1-ethyl-1-methylpyrrolidinium bromide
MEP
418-200-5
69227-51-6
Muta. 2
reaction mass of: trans-2-(1-methylethyl)-1,3-dioxane-5-carboxylic acid; cis-2-(1-methylethyl)-1,3-dioxane-5-carboxylic acid
2-ISOPROPYL-5-CARBOXY-1,3-DIOXANE
418-170-3
116193-72-7
Eye Dam. 1
4-(1-oxo-2-propenyl)-morpholine
ACRYLOYLMORPHOLIN
418-140-1
5117-12-4
Acute Tox. 4; STOT RE 2; Eye Dam. 1; 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
tetrabutylammonium butyltriphenylborate
P3B
418-080-4
120307-06-4
Skin Sens. 1
diethyl{4-[1,5,5-tris(4-diethylaminophenyl)penta-2,4-dienylidene]cyclohexa-2,5-dienylidene}ammonium butyltriphenylborate
IRB
418-070-1
141714-54-7
Skin Sens. 1
2-chloro-5-methyl-pyridine
2-CHLORO-5-METHYLPYRIDINE; CMP
418-050-0
18368-64-4
Acute Tox. 4; Skin Irrit. 2
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
reaction mass of: reaction product of 4,4'-methylenebis[2-(4-hydroxybenzyl)-3,6-dimethylphenol] and 6-diazo-5,6-dihydro-5-oxo-naphthalenesulfonate (1:2); reaction product of 4,4'-methylenebis[2-(4-hydroxybenzyl)-3,6-dimethylphenol] and 6-diazo-5,6-dihydro-5-oxo-naphthalenesulfonate (1:3)
T-271
417-980-4
157321-59-0
Self-react. C; Carc. 2
isopropylammonium 2-(3-benzoylphenyl)propionate
417-970-1
1379932-74-7
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Eye Dam. 1
2-alkoyloxyethyl hydrogen maleate, where alkoyl represents (by weight 70 to 85 % unsaturated octadecoyl, 0.5 to 10 % saturated octadecoyl, and 2 to 18 % saturated hexadecoyl
ATRAC 869
417-960-5
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
N-(2',6'-dimethylphenyl)-2-piperidinecarboxamide hydrochloride
PPX-HCL
417-950-0
65797-42-4
Acute Tox. 4
di-L-para-menthene
PINOLENE
417-870-6
83648-84-4
Skin Irrit. 2; Skin Sens. 1
dibenzylphenylsulfonium hexafluoroantimonate
ZK RT 1507
417-760-8
134164-24-2
STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
flufenoxuron (ISO); 1-(4-(2-cloro-α, α,α-p-trifluorotolyloxy)-2-fluorophenyl)-3-(2,6-difluorobenzolyl)urea
FLUFENOXURON
417-680-3
101463-69-8
Lact.
2-(3-chloropropyl)-2,5,5-trimethyl-1,3-dioxane
5-CHLOR-2-PENTANON-NEOPENTYLKETAL; 5-CHLORO-2-PENTANONE-NEOPENTYLKETAL; CHLORKETAL
417-650-1
88128-57-8
STOT RE 2
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
1,2-bis[4-fluoro-6-{4-sulfo-5-(2-(4-sulfonaphtalene-3-ylazo)-1-hydroxy-3,6-disulfo-8-aminonaphthalene-7-ylazo)phenylamino}-1,3,5-triazin-2ylamino]ethane; x-sodium, y-potassium salts x = 7,755 y =0,245
REACTIVE NAVY DER 7678
417-610-1
155522-09-1
Skin Sens. 1
sodium 4-sulfophenyl-6-((1-oxononyl)amino)hexanoate
OCTAMER
417-550-6
168151-92-6
Skin Sens. 1
reaction mass of: tetrasodium(((2-hydroxyethyl)imino)bis(methylene))bisphosphonate, N-oxide; trisodium ((tetrahydro-2-hydroxy-4H-1,4,2-oxazaphosphorin-4-yl)-methyl)phosphonate, N-oxide, P-oxide
EBO
417-540-1
-
Eye Dam. 1
3-(4-aminophenyl)-2-cyano-2-propenoic acid
AMPCPA
417-480-6
252977-62-1
Skin Sens. 1
reaction mass of: 4-allyl-2,6-bis(2,3-epoxypropyl)phenol; 4-allyl-6-[3-[6-[3-[6-[3-(4-allyl-2,6-bis(2,3-epoxypropyl)phenoxy)-2-hydroxypropyl]-4-allyl-2-(2,3-epoxypropyl)phenoxy]-2-hydroxypropyl]-4-allyl-2-(2,3-epoxypropyl)phenoxy]-2-hydroxypropyl]-2-(2,3-epoxypropyl)phenol; 4-allyl-6-[3-(4-allyl-2,6-bis(2,3-epoxypropyl)phenoxy)-2-hydroxypropyl]-2-(2,3-epoxypropyl)phenol; 4-allyl-6-[3-[6-[3-(4-allyl-2,6-bis(2,3-epoxypropyl)phenoxy)-2-hydroxypropyl]-4-allyl-2-(2,3-epoxypropyl)phenoxy]-2-hydroxypropyl]-2-(2,3-epoxypropyl)phenol
RAS-5 1000 CPS; RAS-5 400 CPS; RAS-5 4000 CPS
417-470-1
-
Muta. 2; Skin Sens. 1
Reaction product of: polyethylene-polyamine-(C16-C18)-alkylamides with monothio-(C2)-alkyl phosphonates
PDN 2287
417-450-2
-
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
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