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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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.

Last updated 16 May 2024. Database contains 4753 unique substances/entries.

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Showing 3,101 - 3,200 of 4,753 results.

Substance Name	EC No.	CAS No.	EU CLP (1272/2008)	EU_BA Directive 2000/54/EC	EU REACH: List of SVHC
Mycobacterium kansasii	-	-		B Bacteria and similar species
Mycobacterium leprae	-	-		B Bacteria and similar species
Mycobacterium malmoense	-	-		B Bacteria and similar species
Mycobacterium marinum	-	-		B Bacteria and similar species
Mycobacterium microti	-	-		B Bacteria and similar species
Mycobacterium paratuberculosis	-	-		B Bacteria and similar species
Mycobacterium scrofulaceum	-	-		B Bacteria and similar species
Mycobacterium simiae	-	-		B Bacteria and similar species
Mycobacterium szulgai	-	-		B Bacteria and similar species
Mycobacterium tuberculosis	-	-		B Bacteria and similar species
Mycobacterium ulcerans	-	-		B Bacteria and similar species
Mycobacterium xenopi	-	-		B Bacteria and similar species
Mycoplasma caviae	-	-		B Bacteria and similar species
Mycoplasma hominis	-	-		B Bacteria and similar species
Mycoplasma pneumoniae	-	-		B Bacteria and similar species
N'-(1,3-dimethylbutylidene)-3-hydroxy-2-naphthohydrazide	435-860-1	214417-91-1	Skin Sens. 1
N, N''-(methylenedi-4,1-phenylene)bis[N'-(4-methylphenyl)urea]	429-380-1	133336-92-2	Skin Sens. 1
N, N''-(methylenedi-4,1-phenylene)bis[N'-octyl]urea	445-760-8	-	Eye Dam. 1; Resp. Sens. 1
N, N',N''-tris(2-methyl-2,3-epoxypropyl)-perhydro-2,4,6-oxo-1,3,5-triazine	435-010-8	26157-73-3	Muta. 2
N, N'-(2,2-dimethylpropylidene)hexamethylenediamine LUPRAGEN VP 9159	401-660-6	1000-78-8	Skin Irrit. 2; Skin Sens. 1
N, N'-bis(trifluoroacetyl)-S, S'-bis-L-homocysteine BMS 208143-01; BTHC	429-670-6	105996-54-1	Eye Dam. 1; Skin Sens. 1
N, N'-diphenyl-p-phenylenediamine; N, N'-diphenyl-1,4-benzenediamine	200-806-4	74-31-7	Skin Sens. 1
N, N'-ethylenebis(vinylsulfonylacetamide) H-603	404-790-1	66710-66-5	Eye Dam. 1; Skin Sens. 1
N, N,N',N'-tetramethyl-3,3'-(propylenebis(iminocarbonyl-4,1-phenylenazo(1,6-dihydro-2-hydroxy-4-methyl-6-oxopyridine-3,1-diyl)))di(propylammonium) dilactate CARTASOL BRILLIANT YELLOW K-6G; CARTASOL BRILLIANT YELLOW K-6G CONC.; GIALLO BRILLANTE CARTASOL K-6G CONC.; JAUNE BRILLANT CARTASOL K-RWA 3904; RWA 3904	403-340-1	164578-09-0	Eye Dam. 1
N, N,N',N'-tetramethyl-p-phenylenediamine	202-831-6	100-22-1	Acute Tox. 4
N, N,N',N'-tetramethyldithiobis(ethylene)diamine dihydrochloride AF-172; FPC 114	405-300-9	17339-60-5	Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
N, N,N',N'-tetramethylethylenediamine	203-744-6	110-18-9	Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B
N, N-(dimethylamino)thioacetamide hydrochloride	435-470-1	27366-72-9	Repr. 1B
N, N-bis(2-(p-toluenesulfonyloxy)ethyl)-p-toluenesulfonamide DIETHANOLAMIN-TRITOSYLAT	412-920-3	16695-22-0	Skin Sens. 1
N, N-bis(2-ethylhexyl)-((1,2,4- triazol-1-yl)methyl)amine CM 23-376; REOMET 30	401-280-0	91273-04-0	Skin Corr. 1B; Skin Sens. 1
N, N-bis(3-aminopropyl)methylamine	203-336-8	105-83-9	Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
N, N-bis(trimethylsilyl)aminopropylmethyldiethoxysilane	445-890-5	201290-01-9	Acute Tox. 4; Skin Sens. 1
N, N-dibutyl-(2,5-dihydro-5-thioxo-1H-tetrazol-1-yl)acetamide	418-290-6	168612-06-4	Eye Irrit. 2; Skin Sens. 1
N, N-diethyl-N',N'-dimethylpropan-1,3-diyl-diamine DDPD	406-610-7	62478-82-4	Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1A
N, N-dimethyl-2-(3-(4-chloro phenyl)-4,5-dihydropyrazol-1- ylphenylsulphonyl)ethylamine HOSTALUX VP 3481	401-410-6	10357-99-0	STOT RE 2; Skin Sens. 1
N, N-dimethylanilinium tetrakis(pentafluorophenyl)borate B1; N,N-DIMETHYLANILINUM TETRAKIS(PENTAFLUOROPHENYL)BORATE; TÉTRAKIS(PENTAFLUOROPHÉNYL)BORATE DE N,N-DIMÉTHYLANILINIUM	422-050-6	118612-00-3	Carc. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
N, N-dimethylformamide; dimethyl formamide	200-679-5	68-12-2	Repr. 1B; Acute Tox. 4; Eye Irrit. 2		yes
N, N-hydrazinodiacetic acid F.H.D.A.	403-510-5	19247-05-3	Acute Tox. 3; STOT RE 2; Skin Sens. 1
N,N'-bis(2,2,6,6-tetramethyl-4-piperidyl)isophthalamide NYLOSTAB S-EED; NYSEED	419-710-0	42774-15-2	Acute Tox. 4; Eye Irrit. 2
N,N'-bis{6-chloro-4-[6-(4-vinylsulfonylphenylazo)-2,7-disulfonicacid-5-hydroxynapht-4-ylamino]-1,3,5-triazin-2-yl}-N-(2-hydroxyethyl)ethane-1,2-diamine, sodium salt RED REN 363	419-500-9	171599-85-2	Eye Dam. 1; Skin Sens. 1
N,N'-diacetylbenzidine	210-338-2	613-35-4	Carc. 1B; Muta. 2; Acute Tox. 4
N,N'-dihexadecyl-N,N'-bis(2-hydroxyethyl)propanediamide QUESTAMIDE H	422-560-9	149591-38-8	Repr. 2; Eye Irrit. 2
N,N'-dimethylbenzidine	-	2810-74-4	Acute Tox. 4
N,N'-methylenedimorpholine; N,N'-methylenebismorpholine [formaldehyde released from N,N'-methylenebismorpholine]; [MBM]	227-062-3	5625-90-1	Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1; Eye Dam. 1
N,N'—1,6-hexanediylbis(N-(2,2,6,6-tetramethyl-piperidin-4-yl)-formamide LICHTSCHUTZMITTEL 1736	413-610-0	124172-53-8	Eye Irrit. 2
N,N,N',N'-tetraglycidyl-4,4'-diamino-3,3'-diethyldiphenylmethane PFMT 1848	410-060-3	130728-76-6	Muta. 2; Skin Sens. 1
N,N,N',N'-tetramethyl-4,4'-methylendianiline	202-959-2	101-61-1	Carc. 1B		yes
N,N,N,N-tetrakis(4,6-bis(butyl- (N-methyl-2,2,6,6-tetramethyl piperidin-4-yl)amino)triazin-2- yl)-4,7-diazadecane-1,10- diamine CHIMASSORB 119; LOWILITE 19	401-990-0	106990-43-6	Skin Sens. 1
N,N,N-trimethylanilinium chloride	205-319-0	138-24-9	Acute Tox. 3
N,N-bis(cocoyl-2-oxypropyl)-N,N-dibutylammonium bromide	431-530-4	1380226-29-8	Skin Corr. 1A; Skin Sens. 1
N,N-diethyl-m-toluamide; deet	205-149-7	134-62-3	Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
N,N-diethylaniline	202-088-8	91-66-7	Acute Tox. 3; STOT RE 2
N,N-dimethyl-m-toluidine	204-495-6	121-72-2	Acute Tox. 3; STOT RE 2
N,N-dimethyl-o-toluidine	210-199-8	609-72-3	Acute Tox. 3; STOT RE 2
N,N-dimethyl-p-toluidine	202-805-4	99-97-8	Acute Tox. 3; STOT RE 2
N,N-dimethylacetamide	204-826-4	127-19-5	Repr. 1B; Acute Tox. 4		yes
N,N-dimethylaniline	204-493-5	121-69-7	Carc. 2; Acute Tox. 3
N,N-dimethylbenzene-1,3-diamine	220-623-3	2836-04-6	Acute Tox. 3
N,N-dimethylhydrazine	200-316-0	57-14-7	Flam. Liq. 2; Carc. 1B; Acute Tox. 3; Skin Corr. 1B
N-(1,3-dimethylbutyl)-N'-(phenyl)-1,4-benzoquinonediimine	429-640-2	52870-46-9	Eye Irrit. 2
N-(2',6'-dimethylphenyl)-2-piperidinecarboxamide hydrochloride PPX-HCL	417-950-0	65797-42-4	Acute Tox. 4
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-(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-(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-amino-4,6-dichloropyrimidin-5-yl)formamide	425-650-6	171887-03-9	Acute Tox. 4; Eye Dam. 1; 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-(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-(dichlorofluoromethylthio)phthalimide; N-(fluorodichloromethylthio)phthalimide	211-952-3	719-96-0	Skin Irrit. 2
N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA]	213-103-2	924-42-5	Carc. 1B; Muta. 1B; STOT RE 1
N-(n-octyl)-2-pyrrolidone NOP; SURFADONE LP-100 SURFACTANT	403-700-8	2687-94-7	Skin Corr. 1B
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-[(benzotriazole-1-yl)methyl)]4-carboxy-benzenesulfonamide BTAD	416-470-9	170292-97-4	Eye Irrit. 2
N-[1-(S)-ethoxycarbonyl-3-phenylpropyl]-L-alanyl-N-carboxyanhydride	430-360-8	84793-24-8	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-[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-[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-[3-[(2-acetyloxy)ethyl](phenyl-methyl)amino]-4-methoxyphenylacetamide BENZANILID-DISPERSE-INTERMEDIATE ZP 9955	411-590-8	70693-57-1	Skin Corr. 1B
N-[4-cyano-3-trifluoromethylphenyl]methacrylamide	427-880-2	90357-53-2	STOT RE 2
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-amidino-N-methylglycine-2-oxopropionate	429-120-5	208535-04-0	Eye Dam. 1
N-benzyl-N-ethyl-(4-(5-nitro-benzo[c]isothiazol-3-ylazo)phenyl)amine	425-300-2	186450-73-7	Skin Sens. 1
n-butyl acetate	204-658-1	123-86-4	Flam. Liq. 3; STOT SE 3
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 methacrylate	202-615-1	97-88-1	Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
n-butyl propionate	209-669-5	590-01-2	Flam. Liq. 3
N-butyl-2-(4-morpholinylcarbonyl)benzamide EP 389	407-730-2	104958-67-0	Eye Irrit. 2; Skin Sens. 1
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-butyronitrile	203-700-6	109-74-0	Flam. Liq. 2; Acute Tox. 3
N-carboxymethyliminobis(ethylenenitrilo)tetra (acetic acid)	200-652-8	67-43-6	Acute Tox. 4; STOT RE 2; Eye Irrit. 2
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-cyclohexylbenzothiazole-2- sulphenamide	202-411-2	95-33-0	Skin Sens. 1
N-dodecyl-[3-(4-(dimethylamino)benzamido)-propyl]dimethylammonium tosylate DIMETHYLPAPAMIDOLAURDIMONIUM TOSYLATE	421-130-8	156679-41-3	Eye Dam. 1; Skin Sens. 1
N-ethyl-2-pyrrolidone; 1-ethylpyrrolidin-2-one	220-250-6	2687-91-4	Repr. 1B
N-ethyl-3-trimethoxysilyl-2-methyl-propanamine	437-720-3	227085-51-0	Eye Dam. 1
N-ethyl-N-methylpiperidinium iodide CATALYST 4017	407-780-5	4186-71-4	Acute Tox. 4
N-ethylaniline	203-135-5	103-69-5	Acute Tox. 3; STOT RE 2
N-hexadecyl(or octadecyl)-N-hexadecyl (or octadecyl)benzamide DTBA	401-980-6	-	Skin Irrit. 2; Skin Sens. 1
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-hexyllithium N-HEXYLLITHIUM	404-950-0	21369-64-2	Water-react. 1; Pyr. Sol. 1; Skin Corr. 1A
N-isopropyl-N'-phenyl-p-phenylenediamine	202-969-7	101-72-4	Acute Tox. 4; Skin Sens. 1

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EU-IMPLANTABLE_MEDICAL_DEVICES-ART_3_ANX_1

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

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Last updated 16 May 2024. Database contains 4753 unique substances/entries.

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