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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 03 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
N,N-dimethyl-m-toluidine	204-495-6	121-72-2	Acute Tox. 3; STOT RE 2
N,N-diethylaniline	202-088-8	91-66-7	Acute Tox. 3; STOT RE 2
N,N-diethyl-m-toluamide; deet	205-149-7	134-62-3	Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
N,N-bis(cocoyl-2-oxypropyl)-N,N-dibutylammonium bromide	431-530-4	1380226-29-8	Skin Corr. 1A; Skin Sens. 1
N,N,N-trimethylanilinium chloride	205-319-0	138-24-9	Acute Tox. 3
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',N'-tetramethyl-4,4'-methylendianiline	202-959-2	101-61-1	Carc. 1B		yes
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'—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'-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'-dimethylbenzidine	-	2810-74-4	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'-diacetylbenzidine	210-338-2	613-35-4	Carc. 1B; Muta. 2; Acute Tox. 4
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'-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-hydrazinodiacetic acid F.H.D.A.	403-510-5	19247-05-3	Acute Tox. 3; STOT RE 2; Skin Sens. 1
N, N-dimethylformamide; dimethyl formamide	200-679-5	68-12-2	Repr. 1B; Acute Tox. 4; Eye Irrit. 2		yes
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-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-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-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-bis(trimethylsilyl)aminopropylmethyldiethoxysilane	445-890-5	201290-01-9	Acute Tox. 4; 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(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(2-(p-toluenesulfonyloxy)ethyl)-p-toluenesulfonamide DIETHANOLAMIN-TRITOSYLAT	412-920-3	16695-22-0	Skin Sens. 1
N, N-(dimethylamino)thioacetamide hydrochloride	435-470-1	27366-72-9	Repr. 1B
N, N,N',N'-tetramethylethylenediamine	203-744-6	110-18-9	Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B
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'-tetramethyl-p-phenylenediamine	202-831-6	100-22-1	Acute Tox. 4
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'-ethylenebis(vinylsulfonylacetamide) H-603	404-790-1	66710-66-5	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'-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'-(2,2-dimethylpropylidene)hexamethylenediamine LUPRAGEN VP 9159	401-660-6	1000-78-8	Skin Irrit. 2; Skin 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''-(methylenedi-4,1-phenylene)bis[N'-octyl]urea	445-760-8	-	Eye Dam. 1; Resp. Sens. 1
N, N''-(methylenedi-4,1-phenylene)bis[N'-(4-methylphenyl)urea]	429-380-1	133336-92-2	Skin Sens. 1
N'-(1,3-dimethylbutylidene)-3-hydroxy-2-naphthohydrazide	435-860-1	214417-91-1	Skin Sens. 1
Mycoplasma pneumoniae	-	-		B Bacteria and similar species
Mycoplasma hominis	-	-		B Bacteria and similar species
Mycoplasma caviae	-	-		B Bacteria and similar species
Mycobacterium xenopi	-	-		B Bacteria and similar species
Mycobacterium ulcerans	-	-		B Bacteria and similar species
Mycobacterium tuberculosis	-	-		B Bacteria and similar species
Mycobacterium szulgai	-	-		B Bacteria and similar species
Mycobacterium simiae	-	-		B Bacteria and similar species
Mycobacterium scrofulaceum	-	-		B Bacteria and similar species
Mycobacterium paratuberculosis	-	-		B Bacteria and similar species
Mycobacterium microti	-	-		B Bacteria and similar species
Mycobacterium marinum	-	-		B Bacteria and similar species

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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 03 May 2024. Database contains 4753 unique substances/entries.

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