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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 25 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
N-methyl-m-toluidine
211-795-0
696-44-6
Acute Tox. 3; STOT RE 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
N-methyl-2-pyrrolidone; 1-methyl-2-pyrrolidone
212-828-1
872-50-4
Repr. 1B; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2
yes
N-isopropyl-N'-phenyl-p-phenylenediamine
202-969-7
101-72-4
Acute Tox. 4; Skin Sens. 1
n-hexyllithium
N-HEXYLLITHIUM
404-950-0
21369-64-2
Water-react. 1; Pyr. Sol. 1; Skin Corr. 1A
n-hexane
203-777-6
110-54-3
Flam. Liq. 2; Repr. 2; Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; STOT SE 3
N-hexadecyl(or octadecyl)-N-hexadecyl (or octadecyl)benzamide
DTBA
401-980-6
-
Skin Irrit. 2; Skin Sens. 1
N-ethylaniline
203-135-5
103-69-5
Acute Tox. 3; STOT RE 2
N-ethyl-N-methylpiperidinium iodide
CATALYST 4017
407-780-5
4186-71-4
Acute Tox. 4
N-ethyl-3-trimethoxysilyl-2-methyl-propanamine
437-720-3
227085-51-0
Eye Dam. 1
N-ethyl-2-pyrrolidone; 1-ethylpyrrolidin-2-one
220-250-6
2687-91-4
Repr. 1B
N-dodecyl-[3-(4-(dimethylamino)benzamido)-propyl]dimethylammonium tosylate
DIMETHYLPAPAMIDOLAURDIMONIUM TOSYLATE
421-130-8
156679-41-3
Eye Dam. 1; Skin Sens. 1
N-cyclohexylbenzothiazole-2- sulphenamide
202-411-2
95-33-0
Skin Sens. 1
N-cyclohexyl-S, S-dioxo; benzo[b]tiophene-2-carboxamide
PREVENTOL VP OC 3061
423-990-1
149118-66-1
Acute Tox. 4; Eye Dam. 1
N-carboxymethyliminobis(ethylenenitrilo)tetra (acetic acid)
200-652-8
67-43-6
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
n-butyronitrile
203-700-6
109-74-0
Flam. Liq. 2; Acute Tox. 3
N-butyl-3-(2-chloro-4-nitrophenylhydrazono)-1-cyano-2-methylprop-1-ene-1,3-dicarboximide
DISPERSOL YELLOW XF
407-970-8
75511-91-0
Skin Sens. 1
N-butyl-2-(4-morpholinylcarbonyl)benzamide
EP 389
407-730-2
104958-67-0
Eye Irrit. 2; Skin Sens. 1
n-butyl propionate
209-669-5
590-01-2
Flam. Liq. 3
n-butyl methacrylate
202-615-1
97-88-1
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
n-butyl acrylate
205-480-7
141-32-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
n-butyl acetate
204-658-1
123-86-4
Flam. Liq. 3; STOT SE 3
N-benzyl-N-ethyl-(4-(5-nitro-benzo[c]isothiazol-3-ylazo)phenyl)amine
425-300-2
186450-73-7
Skin Sens. 1
N-amidino-N-methylglycine-2-oxopropionate
429-120-5
208535-04-0
Eye Dam. 1
N-[6,9-dihydro-9-[[2-hydroxy-1-(hydroxymethyl)ethoxy]methyl]-6-oxo-1H-purin-2-yl]acetamide
424-550-1
84245-12-5
Carc. 1B; Muta. 1B; Repr. 1B
N-[4-cyano-3-trifluoromethylphenyl]methacrylamide
427-880-2
90357-53-2
STOT RE 2
N-[3-[(2-acetyloxy)ethyl](phenyl-methyl)amino]-4-methoxyphenylacetamide
BENZANILID-DISPERSE-INTERMEDIATE ZP 9955
411-590-8
70693-57-1
Skin Corr. 1B
N-[3-(1,1-dimethylethyl)-1H-pyrazol-5-yl]-N'-hydroxy-4-nitrobenzenecarboximidamide
423-530-8
152828-23-4
STOT RE 1; Acute Tox. 4
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
N-[2-(3-acetyl-5-nitrothiophen-2-ylazo)-5-diethylaminophenyl]acetamide
DISPERSOL BLUE C-4G COLOUR; SUBSTANCE H87919
416-860-9
777891-21-1
Repr. 2; Skin Sens. 1
N-[1-(S)-ethoxycarbonyl-3-phenylpropyl]-L-alanyl-N-carboxyanhydride
430-360-8
84793-24-8
Eye Dam. 1; Skin Sens. 1
N-[(benzotriazole-1-yl)methyl)]4-carboxy-benzenesulfonamide
BTAD
416-470-9
170292-97-4
Eye Irrit. 2
N-2-naphthylaniline; N-phenyl-2-naphthylamine
205-223-9
135-88-6
Carc. 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
N-(n-octyl)-2-pyrrolidone
NOP; SURFADONE LP-100 SURFACTANT
403-700-8
2687-94-7
Skin Corr. 1B
N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA]
213-103-2
924-42-5
Carc. 1B; Muta. 1B; STOT RE 1
N-(dichlorofluoromethylthio)phthalimide; N-(fluorodichloromethylthio)phthalimide
211-952-3
719-96-0
Skin Irrit. 2
N-(5-chloro-3-((4-(diethylamino)-2-methylphenyl)imino-4-methyl-6-oxo-1,4-cyclohexadien-1-yl)benzamide
TSD-40
413-200-1
129604-78-0
Skin Sens. 1
N-(4-(3-(4-cyanophenyl)ureido)-3-hydroxyphenyl)-2-(2,4-di-tert-pentylphenoxy)octanamide
UC-129
403-790-9
108673-51-4
Skin Sens. 1
N-(2-amino-4,6-dichloropyrimidin-5-yl)formamide
425-650-6
171887-03-9
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
N-(2-(6-ethyl-7-(4-methylphenoxy)-1H-pyrazolo[1,5-b][1,2,4]triazol-2-yl)propyl)-2-octadecyloxybenzamide
UM-229
407-070-5
142859-67-4
Skin Sens. 1
N-(2-(4-amino-N-ethyl-m-toluidino)ethyl)methanesulphonamide sesquisulphate; 4-(N-ethyl-N-2-methanesulphonylaminoethyl)-2-methylphenylenediamine sesquisulphate monohydrate
247-161-5
25646-71-3
Acute Tox. 4; Skin Sens. 1
N-(2,2,6,6-tetramethyl-1-oxylpiperidin-4-yl)acetamide; (4-acetamido-2,2,6,6-tetra; methyl-1-piperidinyl)oxidanyl
423-840-3
14691-89-5
Acute Tox. 4
N-(2',6'-dimethylphenyl)-2-piperidinecarboxamide hydrochloride
PPX-HCL
417-950-0
65797-42-4
Acute Tox. 4
N-(1,3-dimethylbutyl)-N'-(phenyl)-1,4-benzoquinonediimine
429-640-2
52870-46-9
Eye Irrit. 2
N,N-dimethylhydrazine
200-316-0
57-14-7
Flam. Liq. 2; Carc. 1B; Acute Tox. 3; Skin Corr. 1B
N,N-dimethylbenzene-1,3-diamine
220-623-3
2836-04-6
Acute Tox. 3
N,N-dimethylaniline
204-493-5
121-69-7
Carc. 2; Acute Tox. 3
N,N-dimethylacetamide
204-826-4
127-19-5
Repr. 1B; Acute Tox. 4
yes
N,N-dimethyl-p-toluidine
202-805-4
99-97-8
Acute Tox. 3; STOT RE 2
N,N-dimethyl-o-toluidine
210-199-8
609-72-3
Acute Tox. 3; STOT RE 2
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