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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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