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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
5,5-dimethyl-3-oxocyclohex-1-enyl dimethylcarbamate 5,5-dimethyldihydroresorcinol dimethylcarbamate; dimetan
204-525-8
122-15-6
Acute Tox. 3
5,5-dimethyl-perhydro-pyrimidin-2-one α-(4-trifluoromethylstyryl)-α-(4-trifluoromethyl)cinnamylidenehydrazone
HYDRAMETHYLNON
405-090-9
67485-29-4
STOT RE 1; Acute Tox. 4; Eye Irrit. 2
5,6,12,13-tetrachloroanthra(2,1,9-def:6,5,10-d'e'f')diisoquinoline-1,3,8,10(2H,9H)-tetrone
PIGMENTROT 1017; SUBSTANCE H112287
405-100-1
115662-06-1
Repr. 2
5,6-dihydro-3H-imidazo[2,1-c]-1,2,4-dithiazole-3-thione; etem
251-684-4
33813-20-6
Acute Tox. 4
5,6-dihydroxy-2,3-dihydro-1H-indolium bromide
421-170-6
138937-28-7
Acute Tox. 4; Eye Dam. 1
5,6-dihydroxyindole
IMEXINE OAY
412-130-9
3131-52-0
Acute Tox. 4; Eye Dam. 1
5-(2,4-dioxo-1,2,3,4-tetrahydropyrimidine)-3-fluoro-2-hydroxymethyltetrahydrofuran
123U83; DDFU
415-360-8
41107-56-6
Muta. 2
5-(2-amino-5-cyano-6-[2-(2-hydroxyethoxy)ethylamino]-4-methylpyridin-3-ylazo)-3-methyl-2,4-dicarbonitrilethiophene
410-530-8
107815-88-3
Skin Sens. 1
5-(2-bromophenyl)-2-tert-butyl-2H-tetrazole
WAY-128170
420-820-6
153042-18-3
Flam. Liq. 3; Acute Tox. 4
5-(3,6,9-trioxa-2-undecy loxy)benzo(d)-1,3-dioxolane; sesamex
-
51-14-9
Acute Tox. 4
5-(4-[4-[4-(3,5-dicarboxy-phenyl-azo)phenylamino]-6-morpholin-4-yl-1,3,5-triazin-2-ylamino]phenylazo)isophthalic acid, mixed monosodium and diammonium salt
414-410-6
1379676-83-1
Eye Dam. 1; Skin Sens. 1
5-[[4-chloro-6-[[2-[[4-fluoro-6-[[5-hydroxy-6-[(4-methoxy-2-sulfophenyl)azo]-7-sulfo-2-naphthalenyl]amino]-1,3,5-triazin-2-yl]amino]-1-methylethyl]amino]-1,3,5-triazin-2-yl]amino]-3-[[4-(ethenylsulfonyl)phenyl]azo]-4-hydroxy-naphtalene-2,7-disulfonic acid, sodium salt
ROUGE REACTIF REN 208
418-380-5
168113-78-8
Eye Dam. 1
5-acetoxy-2-(R, S)butyryloxymethyl-1,3-oxathiolane
433-530-1
143446-73-5
Acute Tox. 4; Skin Sens. 1
5-acetyl-3-amino-10,11-dihydro-5H-dibenz[b, f]azepine-hydrochloride
5-ACETYL-3-AMINO-IMINODIBENZYL.HCL
410-490-1
138451-65-7
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
5-amino-2,4,6-triiodo-1,3-benzenedicarbonyldichloride
ATIPACL
417-220-1
37441-29-5
Skin Sens. 1
5-amino-6-methyl-1,3-dihydrobenzoimidazol-2-one
428-410-9
67014-36-2
Acute Tox. 4; Skin Sens. 1
5-bromo-8-naphtholactam
FAT 92'374
413-480-5
24856-00-6
Acute Tox. 4; Skin Sens. 1
5-chloro-1,3-dihydro-2H-indol-2-one
CP-13,853
412-200-9
17630-75-0
Repr. 2; Acute Tox. 4; Skin Sens. 1
5-chloro-2,3-difluoropyridine
CDFP
410-090-7
89402-43-7
Flam. Liq. 3; Acute Tox. 4
5-chloro-2-(4-chlorophenoxy)phenol
429-290-0
3380-30-1
Eye Dam. 1
5-endo-hexyl-bicyclo[2.2.1]hept-2-ene
435-000-3
22094-83-3
Asp. Tox. 1; Skin Irrit. 2
5-ethoxy-5H-furan-2-one
428-330-4
2833-30-9
Skin Corr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
5-ethyl-2,4-dihydro-4-(2-phenoxyethyl)-3H-1,2,4-triazol-3-one
414-470-3
95885-13-5
Acute Tox. 4
5-fluoro-1,3-dimethyl-N-[2-(4-methylpentan-2-yl)phenyl]-1H-pyrazole-4-carboxamide; 2'-[(RS)-1,3-dimethylbutyl]-5-fluoro-1,3-dimethylpyrazole-4-carboxanilide; penflufen
619-823-7
494793-67-8
Carc. 2
5-methylheptan-3-one
208-793-7
541-85-5
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
5-methylhexan-2-one; isoamyl methyl ketone
203-737-8
110-12-3
Flam. Liq. 3; Acute Tox. 4
5-methylpyrazine-2-carboxylic acid
5-METHYLPYRAZINE-2-CARBOXYLIC ACID; ACIDO 5-METILPIRAZIN CARBOSSILICO
413-260-9
5521-55-1
Eye Dam. 1
5-nitro-o-toluidine
202-765-8
99-55-8
Carc. 2; Acute Tox. 3
5-nitro-o-toluidine hydrochloride
256-960-8
51085-52-0
Carc. 2; Acute Tox. 3
5-nitroacenaphthene
210-025-0
602-87-9
Carc. 1B
5-sec-Butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane
-
-
yes
5-sec-Butyl-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [1], 5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane [2] [covering any of the individual stereoisomers of [1] and [2] or any combination thereof]
-
-
yes
5-sec-butyl-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane
-
-
yes
5-tert-butyl-3-isoxazolylamine hydrochloride
BISOX HCL
404-840-2
164578-13-6
Acute Tox. 4; STOT RE 2; Eye Dam. 1
5-thiazolylmethanol
A-87440.0; A-87440.00
414-780-9
38585-74-9
Eye Dam. 1
5-{4-[5-amino-2-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-sulfo-phenylamino]-6-chloro-1,3,5-triazin-2-ylamino}-4-hydroxy-3-(1-sulfo-naphthalen-2-ylazo)-naphthalene-2,7-disulfonicacid sodium salt
ROUGE TZ 4075
418-340-7
157707-94-3
Eye Dam. 1
6,13-dichloro-3,10-bis{2-[4-fluoro-6-(2-sulfophenylamino)-1,3,5-triazin-2-ylamino]propylamino}benzo[5,6][1,4]oxazino[2,3-.b.]phenoxazine-4,11-disulphonic acid, lithium-, sodium salt
BLEU REN 20
418-000-8
163062-28-0
Eye Dam. 1
6,6'-bis(diazo-5,5', 6,6'-tetrahydro-5,5'-dioxo)[methylene-bis(5-(6-diazo-5,6-dihydro-5-oxo-1-naphthylsulphonyloxy)-6-methyl-2-phenylene]di(naphthalene-1-sulfonate)
441-550-5
-
Self-react. C; Carc. 2
6,7-dihydrodipyrido[1,2-α:2',1'- c]pyrazinediylium dihydroxide
301-467-6
94021-76-8
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
6-(1α,5aβ,8aβ,9-pentahydroxy-7β-isopropyl-2β,5β,8β-trimethylperhydro-8bα,9-epoxy-5,8-ethanocyclopenta[1,2-b]indenyl) pyrrole-2-carboxylate; ryania
239-732-2
15662-33-6
Acute Tox. 4
6-(2,3-dimethylmaleimido)hexyl methacrylate
RONACAT RO 305; RONACOAT RO 305
404-870-6
63740-41-0
Skin Sens. 1
6-(nonylamino)-6-oxo-peroxyhexanoic acid
ELFADOX EN 3001
406-680-9
104788-63-8
Org. Perox. C; Eye Dam. 1; Skin Sens. 1
6-(phthalimido)peroxyhexanoic acid
PAP
410-850-8
128275-31-0
Org. Perox. D; Eye Dam. 1
6-dimethylaminohexan-1-ol
AF-507; M-3181
404-680-3
1862-07-3
Acute Tox. 4; Skin Corr. 1B
6-docosyloxy-1-hydroxy-4-(1-(4-hydroxy-3-methylphenanthren-1-yl)-3-oxo-2-oxaphenalen-1-yl)naphthalene-2-carboxylic acid
ENS 131
404-550-6
130263-41-1
Skin Sens. 1
6-ethyl-5-fluoro-4(3H)-pyrimidone
UK-103,442
422-460-5
137234-87-8
Acute Tox. 4
6-fluoro-2-methyl-3-(4-methylthiobenzyl)indene
IN-4; INDENE IN-4
405-410-7
41201-60-9
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
6-glycidyloxynapht-1-yl oxymethyloxirane
429-960-2
27610-48-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
6-hydroxy-1-(3-isopropoxypropyl)-4-methyl-2-oxo-5-[4-(phenylazo)phenylazo]-1,2-dihydro-3-pyridinecarbonitrile
ARANCIO DISPERSO 149; C.I. DISPERSE ORANGE 149; DISPERS ORANGE 149; DISPERSE ORANGE 149; ORANGE DISPERSE 149; TERASIL GOLDGELB 2RS
400-340-3
85136-74-9
Carc. 1B
6-hydroxyindole
IMEXINE OBA
417-020-4
2380-86-1
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
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