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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 19 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-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-(1-methylpropyl)-4-tert-butylphenol
2S4TBP
421-740-4
51390-14-8
Skin Corr. 1B
2-(10-oxo-10H-9-oxa-10-phosphaphenanthren-10-ylmethyl)succinic acid
426-480-5
63562-33-4
Skin Sens. 1
2-(2,4-dichlorophenyl)-1-(1H—1,2,4-triazol-1-yl)pent-4-en-2-ol
TAA
407-850-5
89544-40-1
Acute Tox. 4; Eye Dam. 1
2-(2,4-dichlorophenyl)-2-(2-propenyl)oxirane
EPO
411-210-0
89544-48-9
Skin Irrit. 2; 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-bromoethoxy)anisole
GUAIACOL-O-ETHYLBROMIDE
402-010-4
4463-59-6
Acute Tox. 4
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-hydroxy-3,5-dinitroanilino)ethanol
PIKRAMINROT
412-520-9
99610-72-7
Flam. Sol. 2; Repr. 2; Acute Tox. 4
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-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol; UV-328
247-384-8
25973-55-1
yes
2-(2H-Benzotriazol-2-yl)-4-(tert-butyl)-6-(sec-butyl)phenol; UV-350
253-037-1
36437-37-3
yes
2-(3,4-dichlorophenyl)-4-methyl-1,2,4-oxadiazolidinedione; methazole
243-761-6
20354-26-1
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
2-(3,4-epoxycyclohexyl)ethyltriethoxy silane
425-050-4
10217-34-2
Skin Sens. 1
2-(3-(prop-1-en-2-yl)phenyl)prop-2-yl isocyanate
M-TMI
402-440-2
2094-99-7
Acute Tox. 2; Skin Corr. 1B; STOT RE 2; Resp. Sens. 1; Skin Sens. 1
2-(3-bromophenoxy)tetrahydro-2H-pyran
CP-328,914
429-030-6
57999-49-2
Skin Sens. 1
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
2-(3-iodoprop-2-yn-1-yloxy)ethyl phenylcarbamate
SIS 46 305
408-010-0
88558-41-2
Acute Tox. 4; Eye Dam. 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-chloro-2-methylphenoxy)propionic acid;mecoprop (ISO); 2-(4-chloro-o-tolyloxy)propionic acid; (RS)-2-(4-chloro-o-tolyloxy)propionic acid
202-264-4
7085-19-0;93-65-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
2-(4-chloro-2-methylphenoxy)propionic acid;mecoprop (ISO); 2-(4-chloro-o-tolyloxy)propionic acid; (RS)-2-(4-chloro-o-tolyloxy)propionic acid
202-264-4
7085-19-0;93-65-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 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-(4-methyl-3-pentenyl)anthraquinone
428-320-1
71308-16-2
Acute Tox. 4; Skin Sens. 1
2-(4-tert-butylbenzyl)propionaldehyde
201-289-8
80-54-6
Repr. 1B
2-(4-tert-butylphenyl)ethanol
TBPE
410-020-5
5406-86-0
Repr. 2; STOT RE 2; Eye Dam. 1
2-(5,5-dimethyl-2,4-dioxooxazolidin-3-yl)-4,4-dimethyl-3-oxo-N-(2-methoxy-5-octadecanoylaminophenyl)pentanoic acid amide
443-980-9
221215-20-9
Skin Sens. 1
2-(7-ethyl-1H-indol-3-yl)ethanol
7-ETHYLTRYPTOPHOL
431-020-1
41340-36-7
Acute Tox. 4; STOT RE 2
2-(decylthio)ethylammonium chloride
XU 40304.03L ANTIMICROBIAL
405-640-8
36362-09-1
STOT RE 2; Skin Irrit. 2; Eye Dam. 1
2-(diphosphonomethyl)succinic acid
KEINE
403-070-4
51395-42-7
Skin Corr. 1B; Skin Sens. 1
2-(formylamino)-3-thiophenecarboxylic acid; 2-formamido-3-thiophenecarboxylic acid
431-930-9
43028-69-9
Acute Tox. 4; Skin Sens. 1
2-(isocyanatosulfonylmethyl)benzoic acid methyl ester; (alt.):methyl 2-(isocyanatosulfonylmethyl)benzoate
MCPSI
410-900-9
83056-32-0
Flam. Liq. 3; Muta. 2; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Resp. Sens. 1
2-(morpholinothio)benzothiazole
203-052-4
102-77-2
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2-(N-benzyl-N-methylamino)ethyl 3-amino-2-butenoate
EM
405-350-1
54527-73-0
Skin Sens. 1
2-(O-aminooxy)ethylamine dihydrochloride
AMINOETHER
412-310-7
37866-45-8
Skin Sens. 1
2-(octylthio)ethanol; 2-hydroxyethyl octyl sulphide
222-598-4
3547-33-9
Eye Dam. 1
2-(para-chlorophenyl)glycineamide
420-830-0
102333-75-5
Eye Dam. 1; Skin Sens. 1
2-(propyloxy)ethanol; EGPE
220-548-6
2807-30-9
Acute Tox. 4; Eye Irrit. 2
2-(trimethylammonium)ethoxycarboxybenzene-4-sulfonate
CSPC
411-010-3
117205-23-9
Skin Sens. 1
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