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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 26 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
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
2-((4-amino-2-nitrophenyl)amino)benzoic acid
RO 1082
411-260-3
117907-43-4
Eye Dam. 1; Skin Sens. 1
2-((4-methyl-2-nitrophenyl)amino)ethanol
METHYLGELB
408-090-7
100418-33-5
Acute Tox. 4; Skin Sens. 1
2-(2-(2-hydroxyethoxy)ethyl)-2-aza-bicyclo[2.2.1]heptane
THANCAT AN 20
407-360-1
116230-20-7
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
2-(2-amino-1,3-thiazol-4-yl)-(Z)-2-methoxyiminoacetyl chloride hydrochloride
31 AC-HCL
410-620-7
119154-86-8
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
2-(2-aminoethylamino)ethanol; (AEEA)
203-867-5
111-41-1
Repr. 1B; Skin Corr. 1B; Skin Sens. 1
2-(2-butoxyethoxy)ethanol; diethylene glycol monobutyl ether
203-961-6
112-34-5
Eye Irrit. 2
2-(2-butoxyethoxy)ethyl thiocyanate
203-985-7
112-56-1
Flam. Liq. 3; Acute Tox. 3
2-(2-hexyloxyethoxy)ethanol; DEGHE; diethylene glycol monohexyl ether; 3,6-dioxa-1-dodecanol; hexyl carbitol; 3,6-dioxadodecan-1-ol
203-988-3
112-59-4
Acute Tox. 4; Eye Dam. 1
2-(2-iodoethyl)-1,3-propanediol diacetate
BRL 47539
411-780-0
127047-77-2
Acute Tox. 4
2-(2-methoxyethoxy)ethanol; diethylene glycol monomethyl ether
203-906-6
111-77-3
Repr. 2
2-(3,4-epoxycyclohexyl)ethyltriethoxy silane
425-050-4
10217-34-2
Skin Sens. 1
2-(4-(3-(4-chlorophenyl)-2-pyra zolin-1-yl)phenylsulfonyl)ethyldimethylammonium formate
HOSTALUX VP 3481-1 HOSTALUX N2R
402-120-2
133514-97-3
Skin Corr. 1B; STOT RE 2; Skin Sens. 1
2-(4-(3-(4-chlorophenyl)-4,5- dihydropyrazolyl)phenylsulphonyl) ethyldimethylammonium hydrogen phosphonate
AZURANT PYRAZOLINE MR 5401; PYRAZOLINE BRIGHTENER MR 5401; UVITEX 4457
402-490-5
106359-93-7
Eye Irrit. 2
2-(4-(4-(butyl-(1-methylhexyl)amino)phenyl)-3-cyano-5-oxo-1,5-dihydropyrrol-2-ylidene)propandinitrile
429-180-2
157362-53-3
Skin Sens. 1
2-(4-(4-cyano-3-methylisothiazol-5-ylazo)-N-ethyl-3-methylanilino)ethyl acetate
TTP MAGENTA 3
405-480-9
110260-50-9
Acute Tox. 4; STOT RE 2; Skin Irrit. 2
2-(4-(5,6(or 6,7)-dichloro-1,3-benzothiazol-2-ylazo)-N-methyl-m-toluidino)ethyl acetate
BRILLANT RED 1047729; BRILLIANT RED 1047729; ROUGE BRILLANT 1047729
405-440-0
149172-69-0
Skin Sens. 1
2-(4-(diethylaminopropylcarbamoyl)phenylazo)-3-oxo-N-(2,3-dihydro-2-oxobenzimidazol-5-yl)butyramide
PIGMENT ADDITIV C
404-910-2
164578-14-7
Skin Sens. 1
2-(4-aminophenyl)-6-tert-butyl-1H-pyrazolo[1,5-b][1,2,4]triazole
FC-102B; M-3218
415-910-7
152828-25-6
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
2-(morpholinothio)benzothiazole
203-052-4
102-77-2
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2-(para-chlorophenyl)glycineamide
420-830-0
102333-75-5
Eye Dam. 1; Skin Sens. 1
2-(trimethylammonium)ethoxycarboxybenzene-4-sulfonate
CSPC
411-010-3
117205-23-9
Skin Sens. 1
2-[2-(2-butoxyethoxy)ethoxy]ethanol; TEGBE; triethylene glycol monobutylether; butoxytriethylene glycol
205-592-6
143-22-6
Eye Dam. 1
2-[2-hydroxy-3-(2-chlorophenyl)carbamoyl-1-naphthylazo]-7-[2-hydroxy-3-(3-methylphenyl)carbamoyl-1-naphthylazo]fluoren-9-one
P-964
420-580-2
151798-26-4
Repr. 1B
2-[4-(3,6-dimethylheptan-3-yl)phenoxy]ethanol
687-832-3
1119449-37-4
yes
2-amino-2-methylpropanol
204-709-8
124-68-5
Eye Irrit. 2; Skin Irrit. 2
2-amino-4-bromo-5-chlorobenzoic acid
ACIDE CÉBRANILIQUE
424-700-4
150812-32-1
Eye Dam. 1
2-amino-4-dimethylamino-6-trifluoroethoxy-1,3,5-triazine
415-500-8
145963-84-4
Acute Tox. 4; STOT RE 2
2-aminoethanol; ethanolamine
205-483-3
141-43-5
Acute Tox. 4; Skin Corr. 1B
2-aminoethyldimethylamine; 2-dimethylaminoethylamine
203-541-2
108-00-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
2-aminosulfonyl-N, N-dimethylnicotinamide
DAM 520
413-440-7
112006-75-4
Skin Sens. 1
2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone
CG 25-369; IRGACURE 369; TK 11-319
404-360-3
119313-12-1
Repr. 1B
yes
2-butoxyethanol; ethyleneglycol monobutyl ether; butyl cellosolve
203-905-0
111-76-2
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
2-butoxyethyl acetate; butylglycol acetate
203-933-3
112-07-2
Acute Tox. 4
2-butyl-1,3-diazaspiro[4.4]non-1-en-4-one hydrochloride
SR 48001 A
424-560-4
151257-01-1
Acute Tox. 4; Eye Irrit. 2
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
2-chloro-4,5-difluorobenzoic acid
2-CHLORO-4,5-DIFLUORO BENZOIC ACID; BA-6; CDFBA
405-380-5
110877-64-0
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
2-chloro-4-fluoro-5-nitrophenyl(isobutyl)carbonate
427-020-6
141772-37-4
STOT RE 2; Skin Sens. 1
2-chloro-4-nitroaniline
204-502-2
121-87-9
Acute Tox. 4
2-chloro-5-chloromethylthiazole
2-CHLORO-5-CHLOROMETHYLTHIAZOLE
429-830-5
105827-91-6
Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; 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
2-chloro-5-sec-hexadecylhydroquinone
AF-377
407-750-1
137193-60-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2-chloro-6-(ethylamino)-4-nitrophenol
ROT CO
411-440-1
131657-78-8
Acute Tox. 4; Skin Sens. 1
2-chloro-N-(4-methylphenyl)acetamide
435-170-9
16634-82-5
Eye Dam. 1; Skin Sens. 1
2-chloroethanol; ethylene chlorohydrin
203-459-7
107-07-3
Acute Tox. 2; Acute Tox. 1
2-cyclohexylidene-2-phenylacetonitrile
423-740-1
10461-98-0
Acute Tox. 4
2-diethylaminoethanol; N,N-diethylethanolamine
202-845-2
100-37-8
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
2-diethylaminoethyl methacrylate
203-275-7
105-16-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2-dimethylaminoethanol; N,N-dimethylethanolamine
203-542-8
108-01-0
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
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