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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 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: 3,5-bis-tert-butylsalicylic acid and aluminiumsulfate
E-101
420-310-3
-
Acute Tox. 4
Reaction product of: acetophenone, formaldehyde, cyclohexylamine, methanol and acetic acid
R633
406-230-1
224635-63-6
Flam. Liq. 3; Carc. 2; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
reaction product of: borax, hydrogen peroxide, acetic acid anhydride and acetic acid
PES-SOLID
420-070-1
-
Org. Perox. D; Acute Tox. 4; Skin Corr. 1A
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 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
reaction product of: saturated, monounsaturated and multiple unsaturated long-chained partly estrified alcohols of vegetable origin (Brassica napus L., Brassica rapa L., Helianthus annuus L., Glycine hispida, Gossypium hirsutum L., Cocos nucifera L., Elaeis guineensis) with O, O-diisobutyldithiophosphate and 2-ethylhexylamine and hydrogen peroxide
428-630-5
-
Skin Sens. 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
reaction products of diisopropanolamine with formaldehyde (1:4)
432-440-8
220444-73-5
Carc. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
reaction products of tungsten hexachloride with 2-methylpropan-2-ol, nonylphenol and pentane-2,4-dione
ORGANOTUNGSTEN COMPOUND CONCENTRATE
408-250-6
121754-49-2
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
reaction products of: aniline-terephthalaldehyde-o-toluidine condensate with maleic anhydride
MP-2000; MP-2000X
406-620-1
129217-90-9
Skin Sens. 1
reaction products of: trimethylhexamethylene diamine (a mixture of 2,2,4-trimethyl-1,6-hexanediamine and 2,4,4-trimethyl-1,6-hexanediamine, EINECS listed), Epoxide 8 (mono[(C10-C16-alkyloxy)methyl]oxirane derivatives) and p-toluene-sulfonic acid
FCC 963
410-880-1
147170-38-5
Acute Tox. 4; Skin Corr. 1B
R—2,3-epoxy-1-propanol
R-GLYCIDOL
404-660-4
57044-25-4
Self-react. C; Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
S-(3-(triethoxysilyl)propyl)octanethioate
436-690-9
220727-26-4
Skin Sens. 1
S-(3-trimethoxysilyl)propyl 19-isocyanato-11-(6-isocyanatohexyl)-10,12-dioxo-2,9,11,13-tetraazanonadecanethioate
ALKYL ISOCYANATE SILANE SCD 617
402-290-8
85702-90-5
Flam. Liq. 3; Resp. Sens. 1; 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
sodium ((N-(3-trimethylammoniopropyl)sulfamoyl)methylsulfonatophthalocyaninato)copper(II)
C.I. BASIC BLUE 163
407-340-2
124719-24-0
Eye Dam. 1
sodium (1,0-1,95)/lithium (0,051) 5-((5-((5-chloro-6-fluoro-pyrimidin-4-yl)amino)-2-sulfonatophenyl)azo)-1,2-dihydro-6-hydroxy-1,4-dimethyl-2-oxo-3-pyridinemethylsulfonate
LEVAFIX GELB FC 47859; REACTIVE YELLOW FC 47859
413-470-0
134595-59-8
Skin Sens. 1
sodium (1-(5-(4-(4-anilino-3-sulphophenylazo)-2-methyl-5-methylsulphonamidophenylazo)4-hydroxy-2-oxido-3-(phenylazo)phenylazo)-5-nitro-4-sulphonato-2-naphtholato)iron(II)
SÄUREBRAUN 6230
401-220-3
-
Acute Tox. 4
sodium (6R-trans)-7-amino-8-oxo-3-[[[1-(sulfomethyl)-1H-tetrazol-5-yl]thio]methyl]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monohydrate
426-520-1
71420-85-4
Skin Sens. 1
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
sodium (R)-2-(2,4-dichlorophenoxy)propionate
DUPLOSAN-DP-NATRIUM; DUPOLSON-DP-NATRIUM
413-340-3
119299-10-4
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
sodium (Z)-3-chloro-3-(4-chlorophenyl)-1-hydroxy-2-propene-1-sulfonate
420-800-7
1379804-37-1
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
sodium 1,1,2,2,3,3,4,4,4-nonafluoro-1-butanesulfinate
422-100-7
102061-82-5
Eye Dam. 1; Skin Sens. 1
sodium 1,2-bis[4-[4-{4-(4-sulfophenylazo)-2-sulfophenylazo}-2-ureido-phenyl-amino]-6-fluoro-1,3,5-triazin-2-ylamino]-propane, sodium salt
REACTIVE ORANGE TZ 3931
413-990-8
149850-31-7
Skin Sens. 1
sodium 2-(4-(4-fluoro-6-(2-sulfo-ethylamino)-[1,3,5]triazin-2-ylamino)-2-ureido-phenylazo)-5-(4-sulfophenylazo)benzene-1-sulfonate
FAT 40'436; FAT 40'436/A; REACTIVE ORANGE TZ 3538
410-770-3
146177-84-6
Skin Sens. 1
sodium 2-(nonanoyloxy)benzenesulfonate
434-360-9
91125-43-8
Eye Dam. 1; Skin Sens. 1
sodium 2-[[4-[(4,6-dichloro-1,3,5-triazin-2-yl)amino]phenyl]sulfonyl]ethyl sulfate
430-890-1
81992-66-7
Skin Sens. 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 2-benzoyloxy-1-hydroxyethane-sulfonate
BENZOYL BISULFITE
410-680-4
1379676-76-2
Skin Sens. 1
sodium 2-ethylhexanolate
NA-2-ETHYLHEXANOLAT
406-150-7
38411-13-1
Flam. Sol. 1; Skin Corr. 1B
sodium 3,5-bis(3-(2,4-di-tert-pentylphenoxy)propylcarbamoyl)benzenesulfonate
AF-365
405-510-0
121216-78-2
Skin Irrit. 2; Skin Sens. 1
sodium 3,5-bis(tetradecyloxycarbonyl)benzenesulfinate
AF-390
407-720-8
155160-86-4
Skin Sens. 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-(2-acetamido-4-(4-(2-hydroxybutoxy)phenylazo)phenylazo)benzenesulfonate
YELLOW E-JD 3442
410-150-2
147703-65-9
Skin Sens. 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 3-(methoxycarbonyl)-4-oxo-3,4,5,6-tetrahydro-2-pyridinolate
418-410-7
139122-78-4
Eye Irrit. 2
sodium 3-acetoacetylamino-4-methoxytolyl-6-sulfonate
ACETESSIG-KRESIDINSULFOSÄURES NATRIUMSALZ
411-680-7
133167-77-8
Skin Sens. 1
sodium 4-(2,4,4-trimethylpentylcarbonyloxy)benzenesulfonate
ACTIZONE; PG 85; PHENOLESTER C; PHENOLESTER C/S
400-030-8
94612-91-6
Acute Tox. 3; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Sens. 1
sodium 4-(4-chloro-6-(N-ethylanilino)-1,3,5-triazin-2-ylamino)-2-(1-(2-chlorophenyl)-5-hydroxy-3-methyl-1H-pyrazol-4-ylazo)benzenesulfonate
ACID YELLOW HT 2803; MONOAZO YELLOW HT 2803
407-800-2
136213-75-7
Skin Sens. 1
sodium 4-[4-(4-hydroxyphenylazo)phenylamino]-3-nitrobenzenesulfonate
ORANGE JOG 365
416-370-5
156738-27-1
Skin Sens. 1
sodium 4-chloro-1-hydroxybutane-1-sulfonate
BISULPHITE ADDUCT; GR59658A
406-190-5
54322-20-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
sodium 4-hydroxy-3-(N'-(2-(2-hydroxyethylenesulfonyl)ethylene)ureido)-5-nitrobenzenesulfonate
425-460-3
1379676-84-2
Skin Sens. 1
sodium 4-sulfophenyl-6-((1-oxononyl)amino)hexanoate
OCTAMER
417-550-6
168151-92-6
Skin Sens. 1
sodium 5-n-butylbenzotriazole
COBRATEC 435
404-450-2
118685-34-0
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
sodium [29H,31H-phthalocyaninato-(2-)-N29,N30,N31,N32]-((3-(N-methyl-N-(2-hydroxyethyl)amino)propyl)amino)sulfonyl-sulfonato, copper complex
DIRECT BLUE CA 36133
412-730-0
150522-10-4
Skin Corr. 1B
sodium and potassium 4-(3-aminopropylamino)-2,6-bis[3(4-methoxy-2-sulfophenylazo)4-hydroxy-2-sulfo-7-naphthylamino]-1,3,5-triazine
RED ULK 1324
416-280-6
156769-97-0
Skin Sens. 1
sodium benzoyloxybenzene-4-sulfonate
LU20
405-450-5
66531-87-1
Skin Sens. 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
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