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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 13 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
reaction product of amorphous silica (50-85 %), butyl (1-methylpropyl) magnesium (3-15 %), tetraethyl orthosilicate (5-15 %) and titanium tetrachloride (5-20 %)
432-200-2
1379679-02-3
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
Reaction product of: 1,2,3-propanetricarboxylic acid, 2-hydroxy, diethyl ester, 1-propanol and zirconium tetra-n-propanolate
TYZOR ZEC
417-110-3
1379678-99-5
Flam. Liq. 2; Skin Irrit. 2; Eye Dam. 1
C12-14-tert-alkyl ammonium 1-amino-9,10-dihydro-9,10-dioxo-4-(2,4,6-trimethylanilino)-anthracen-2-sulfonate
ORASOL BLAU 761B
414-110-5
1379678-96-2
Eye Dam. 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
C8-10 alkyl dimethyl hydroxyethyl ammoniumchloride (chain < C8: <3 %, chain = C8: 15 %-70 %, chain = C10: 30 %- 85 %, chain > C10: <3 %)
417-360-3
1379678-84-8
Acute Tox. 4; Skin Irrit. 2
sodium 4-hydroxy-3-(N'-(2-(2-hydroxyethylenesulfonyl)ethylene)ureido)-5-nitrobenzenesulfonate
425-460-3
1379676-84-2
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
tetrasodium 4-hydroxy-5-[4-[3-(2-sulfatoethanesulfonyl)phenylamino]-6-morpholin-4-yl-1,3,5-triazin-2-ylamino]-3-(1-sulfonatonaphthalen-2-ylazo)naphthalene-2,7-disulfonate
REACTIVE RED 202 (ESTER)
413-070-6
1379676-82-0
Skin Sens. 1
sodium 2-benzoyloxy-1-hydroxyethane-sulfonate
BENZOYL BISULFITE
410-680-4
1379676-76-2
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
(Z)-1-benzo[b]thien-2-ylethanone oxime hydrochloride
A-83851
410-780-8
1379676-72-8
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
2-(4-methyl-2-phenyl-1-piperazinyl)benzenemethanol monohydrochloride
420-200-5
1379676-70-6
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
benzyl(S)-2-[(2'-cyanobiphenyl-4-ylmethyl)pentanoylamino]-3-methylbutyrate
427-470-3
137864-22-3
Acute Tox. 4; Skin Sens. 1
4-ethyl-2-methyl-2-isopentyl-1,3-oxazolidine
ZOLDINE (R) MS-52
410-470-2
137796-06-6
Skin Corr. 1B; Skin Sens. 1
dinickel orthosilicate
237-411-1
13775-54-7
Carc. 1A; STOT RE 1; Skin Sens. 1
trisodium hexafluoroaluminate
237-410-6
13775-53-6
STOT RE 1; Acute Tox. 4
nickel bis(sulfamidate); nickel sulfamate
237-396-1
13770-89-3
Carc. 1A; Muta. 2; Repr. 1B; Acute Tox. 4; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
calcium chromate
237-366-8
13765-19-0
Carc. 1B; Acute Tox. 4
2-butyl-2-ethyl-1,5-diaminopentane
C11-NEODIAMINE
412-700-7
137605-95-9
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; 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
reaction mass of O, O'-diisopropyl (pentathio)dithioformate and O, O'-diisopropyl (trithio)dithioformate and O, O'-diisopropyl (tetrathio)dithioformate
ROBAC AS/100
403-030-6
137398-54-0
Acute Tox. 4; Skin Sens. 1
[(dimethylsilylene)bis((1,2,3,3a,7a-η)-1H-inden-1-ylidene)dimethyl]hafnium
M1
422-060-0
137390-08-0
Acute Tox. 2
6-ethyl-5-fluoro-4(3H)-pyrimidone
UK-103,442
422-460-5
137234-87-8
Acute Tox. 4
2-chloro-5-sec-hexadecylhydroquinone
AF-377
407-750-1
137193-60-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
metam-sodium (ISO); sodium methyldithiocarbamate
205-293-0
137-42-8
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
ziram (ISO); zinc bis dimethyldithiocarbamate
205-288-3
137-30-4
Acute Tox. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Eye Dam. 1; Skin Sens. 1
thiram (ISO); tetramethylthiuram disulphide
205-286-2
137-26-8
Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2,4,5-trimethylaniline
205-282-0
137-17-7
Carc. 1B; Acute Tox. 3
mecrilate; methyl 2-cyanoacrylate
205-275-2
137-05-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
1-dimethylcarbamoyl-4-(2-sulfonatoethyl)pyridinium
418-440-0
136997-71-2
Skin Sens. 1
behenamidopropyl-dimethyl-(dihydroxypropyl) ammonium chloride
LEXQUAT AMG-BEO (CONCENTRATE)
423-420-1
136920-10-0
Eye Dam. 1; Skin Sens. 1
reaction mass of: 2,2',2'',2'''-(ethylenedinitrilotetrakis-N, N-di(C16)alkylacetamide; 2,2',2'',2'''-(ethylenedinitrilotetrakis-N, N-di(C18)alkylacetamide
KEROFLUX ES 3241
406-640-0
136920-07-5
Skin Sens. 1
nickel dithiocyanate
237-205-1
13689-92-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
tris[2-chloro-1-(chloromethyl)ethyl] phosphate
237-159-2
13674-87-8
Carc. 2
nickel(II) palmitate
237-138-8
13654-40-5
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
(3S,4aS,8aS)-2-[(2R,3S)-3-amino-2-hydroxy-4-phenylbutyl]-N-tert-butyldecahydroisoquinoline-3-carboxamide
PTH-AA
430-230-0
136522-17-3
Acute Tox. 4
1-((2-quinolinyl-carbonyl)oxy)-2,5-pyrrolidinedione
PTH-SUCCINIMIDESTER
418-630-3
136465-99-1
Eye Dam. 1; Skin Sens. 1
(3S, 4aS, 8aS)-N-tert-butyldecahydro-3-isoquinolinecarboxamide
420-380-5
136465-81-1
Acute Tox. 4; Eye Dam. 1
fluquinconazole (ISO);3-(2,4-dichlorophenyl)-6-fluoro-2-(1H-1,2,4-triazol-1-yl)quinazolin-4-(3H)-one
FLUQUINCONAZOLE
411-960-9
136426-54-5
Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Irrit. 2
nickel diperchlorate; perchloric acid, nickel(II) salt
237-124-1
13637-71-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
trisodium 3-amino-6,13-dichloro-10-((3-((4-chloro-6-(2-sulfophenylamino)-1,3,5-triazin-2-yl)amino)propyl) amino)-4,11-triphenoxydioxazinedisulfonate
BLEU REACTIF CAC 10; DIOXAZINE MONCHLORTRIAZINE; FAT NO. 40 407; REACTIVE BLUE CAC 10
410-130-3
136248-03-8
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
2-((4-(ethyl-(2-hydroxyethyl)amino)-2-methylphenyl)azo)-6-methoxy-3-methyl-benzothiazolium methylsulfate
FAT 40'398; FAT 40'398/E
411-100-2
136213-73-5
STOT RE 2; Skin Sens. 1
bis(4-(1,2-bis(ethoxycarbonyl)ethylamino)-3-methylcyclohexyl)methane
DESMOPHEN VP-LS 2973 E; DESMOPHEN VP-LS 2975 E; DESMOPHEN VP-LS 2985 E
412-060-9
136210-32-7
Skin Sens. 1
tetraethyl N, N'-(methylenedicyclohexane-4,1-diyl)bis-DL-aspartate
429-270-1
136210-30-5
Skin Sens. 1
2,5-dimercaptomethyl-1,4-dithiane
HR-11
419-770-8
136122-15-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
erbon (ISO); 2-(2,4,5-trichlorophenoxy)ethyl2,2-dichloropropionate
-
136-25-4
Acute Tox. 4
zinc bis(dibutyldithiocarbamate)
205-232-8
136-23-2
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
phosphonic acid
237-066-7
13598-36-2
Acute Tox. 4; Skin Corr. 1A
4,4'-(1,3-phenylene-bis(1-methylethylidene))bis-phenol
428-970-4
13595-25-0
Repr. 2; Skin Sens. 1
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