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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 26 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
[1R-(1-α, 2β,5α)]-mono[5-methyl-2-(1-methylethyl)cyclohexyl]butanedioate
426-890-4
77341-67-4
Eye Dam. 1
[(tolyloxy)methyl]oxirane; cresyl glycidyl ether
247-711-4
26447-14-3
Muta. 2; Skin Irrit. 2; Skin Sens. 1
[(p-tolyloxy)methyl]oxirane
218-574-8
2186-24-5
Muta. 2; Skin Irrit. 2; Skin Sens. 1
[(m-tolyloxy)methyl]oxirane
218-575-3
2186-25-6
Muta. 2; Skin Irrit. 2; Skin Sens. 1
[(dimethylsilylene)bis((1,2,3,3a,7a-η)-1H-inden-1-ylidene)dimethyl]hafnium
M1
422-060-0
137390-08-0
Acute Tox. 2
[(4S, 5S)-4-benzyl-2-oxo-5-oxazolidinyl]methyl 4-nitrobenzenesulfonate
416-360-0
162221-28-5
Skin Sens. 1
[(1-methyl-1,2-ethanediyl)bis[nitrilobis(methylene)]]tetrakis(phosphonic acid)
421-940-1
28698-31-9
Eye Dam. 1
9-vinylcarbazole
216-055-0
1484-13-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
9-(2-propenyloxy)tricyclo[5.2.1.0(2,6)]dec-3(or-4-)-ene
FLEUROXENE
430-830-2
26912-64-1
Skin Irrit. 2
9,9-bis(4-hydroxyphenyl)fluorene
BPFL; FLUOREN-BIS-PHENOL
406-950-6
3236-71-3
Eye Irrit. 2; Skin Irrit. 2
8-p-menthyl hydroperoxide; p-menthane hydroperoxide
201-281-4
80-47-7
Org. Perox. D; Skin Corr. 1B; Acute Tox. 4
8-azaspiro[4.5]decane-7,9-dione
3,3-TETRAMETHYLENE GLUTARIMIDE
427-770-4
1075-89-4
Acute Tox. 3
8-amino-7-methylquinoline
8-AMINO-7-METHYLCHINOLIN
412-760-4
5470-82-6
Acute Tox. 4; Skin Sens. 1
8,9-dinorborn-5-ene-2,3-dicarboxylic anhydride
620-411-4
123748-85-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride
204-957-7
129-64-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
8,9,10-trinorborn-2-yl acrylate
-
10027-06-2
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
8,8-dimethyl-7-isopropyl-6,10-dioxaspiro[4.5]decane
OPALAL
424-030-2
62406-73-9
Skin Irrit. 2
7a-ethyl-3,5-bis(1-methylethyl)-2,3,4,5-tetrahydrooxazolo[3,4-c]-2,3,4,5-tetrahydrooxazole
ZOLDINE RD-20
417-140-7
79185-77-6
Skin Irrit. 2
7-methylocta-1,6-diene
7-METHYL-1,6-OCTADIENE
404-210-7
42152-47-6
Flam. Liq. 3
7-methoxy-6-(3-morpholin-4-yl-propoxy)-3H-quinazolin-4-one [containing ≥ 0,5 % formamide (EC No 200-842-0)]
429-400-7
199327-61-2
Repr. 1B
7-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxoquinoline-3-carboxylic acid
FLUORCHINOLONCARBONSÄURE
405-050-0
86393-33-1
Acute Tox. 4
7-amino-4-hydroxy-2-naphthalenesulfonic acid, coupled with 5 (or 8) -amino-8 (or 5)-[[4-[[4-[[4-amino-6(or 7)-sulfo-1-naphthyl]azo]phenyl]amino]-3-sulfophenyl]azo]-2-naphthalenesulfonic acid and 4-hydroxy-7-(phenylamino)-2-naphthalenesulfonic acid, sodium salt
424-850-0
189702-72-5
Eye Dam. 1
7-amino-3-((5-carboxymethyl-4- methyl-1,3-thiazol-2- ylthio)methyl)-8-oxo-5-thia-1- azabicyclo(4.2.0)oct-2-ene-2- carboxylic acid
TACS
403-690-5
111298-82-9
Resp. Sens. 1; Skin Sens. 1
7-[((4,6-dichloro-1,3,5-triazin-2-yl)amino)-4-hydroxy-3-(4-((2-sulfoxy)ethyl)sulfonyl)phenylazo]naphthalene-2-sulfonic acid
ORANGE BIREACTIVE DYE
407-050-6
117715-57-8
Skin Sens. 1
7,7-dimethyl-3-oxa-6-azaoctan-1-ol
FLEXSORB-SE
400-390-6
87787-67-5
Skin Corr. 1A; Acute Tox. 4
6-phenyl-1,3,5-triazine-2,4- diyldiamine; 6-phenyl-1,3,5-triazine-2,4-diamine; benzoguanamine
202-095-6
91-76-9
Acute Tox. 4
6-methyl-2,4-bis(methylthio)phenylene-1,3-diamine
DM-C-TDA; DMTDA; ETHACURE (R) 300 CURATIVE
403-240-8
106264-79-3
Acute Tox. 4; Skin Sens. 1
6-methoxy-m-toluidine; p-cresidine
204-419-1
120-71-8
Carc. 1B; Acute Tox. 4
yes
6-hydroxyindole
IMEXINE OBA
417-020-4
2380-86-1
Acute Tox. 4; Eye Dam. 1; 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-glycidyloxynapht-1-yl oxymethyloxirane
429-960-2
27610-48-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
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-ethyl-5-fluoro-4(3H)-pyrimidone
UK-103,442
422-460-5
137234-87-8
Acute Tox. 4
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-dimethylaminohexan-1-ol
AF-507; M-3181
404-680-3
1862-07-3
Acute Tox. 4; Skin Corr. 1B
6-(phthalimido)peroxyhexanoic acid
PAP
410-850-8
128275-31-0
Org. Perox. D; Eye Dam. 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-(2,3-dimethylmaleimido)hexyl methacrylate
RONACAT RO 305; RONACOAT RO 305
404-870-6
63740-41-0
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
6,7-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
6,6'-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
6,13-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
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
5-thiazolylmethanol
A-87440.0; A-87440.00
414-780-9
38585-74-9
Eye Dam. 1
5-tert-butyl-3-isoxazolylamine hydrochloride
BISOX HCL
404-840-2
164578-13-6
Acute Tox. 4; STOT RE 2; Eye Dam. 1
5-sec-butyl-2-(4,6-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-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane
-
-
yes
5-nitroacenaphthene
210-025-0
602-87-9
Carc. 1B
5-nitro-o-toluidine hydrochloride
256-960-8
51085-52-0
Carc. 2; Acute Tox. 3
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