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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
iprobenfos(ISO); S-benzyl diisopropyl phosphorothioate
247-449-0
26087-47-8
Acute Tox. 4
isobenzan (ISO); 1,3,4,5,6,7,8,8-octachloro-1,3,3a,4,7,7a-hexahydro-4,7-methanoisobenzofuran
206-045-4
297-78-9
Acute Tox. 1; Acute Tox. 2
isobutyl but-3-enoate
ISOBUTYLVINYL ACETATE; IVA
401-170-2
24342-03-8
Flam. Liq. 3
isofenphos (ISO); O-ethyl O-2-isopropoxycarbonylphenyl-isopropylphosphoramidothioate
246-814-1
25311-71-1
Acute Tox. 3
isooctane
247-861-0
26635-64-3
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
isooctyl acrylate
249-707-8
29590-42-9
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
isoprocarb (ISO); 2-isopropylphenyl N-methylcarbamate
220-114-6
2631-40-5
Acute Tox. 4
Lead cyanamidate
244-073-9
20837-86-9
yes
lead hexafluorosilicate
247-278-1
25808-74-6
Repr. 1A; Acute Tox. 4; STOT RE 2
lenacil (ISO); 3-cyclohexyl-6,7- dihydro-1H-cyclopenta[d]pyrimidine-2,4(3H,5H)-dione
218-499-0
2164-08-1
Carc. 2
leptophos (ISO); O-4-bromo-2,5-dichlorophenyl O-methyl phenylphosphorothioate
244-472-8
21609-90-5
Acute Tox. 3; STOT SE 1; Acute Tox. 4
lithium perfluorooctane sulfonate; lithium heptadecafluorooctanesulfonate
249-644-6
29457-72-5
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
lithium potassium sodium N,N''-bis{6-[7-[4-(4-chloro-1,3,5-triazin-2-yl)amino-4-(2-ureidophenylazo)]naphthalene-1,3,6-trisulfonato}-N'-(2-aminoethyl)piperazine
427-850-9
202667-43-4
Skin Sens. 1
m-tolylidene diisocyanate; toluene-diisocyanate
247-722-4
26471-62-5
Carc. 2; Acute Tox. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
malachite green oxalate
219-441-7
2437-29-8
Repr. 2; Acute Tox. 4; Eye Dam. 1
MCPA-thioethyl (ISO); S-ethyl (4-chloro-2-methylphenoxy)ethanethioate; S-ethyl 4-chloro-o-tolyloxythioacetate
246-831-4
25319-90-8
Acute Tox. 4
mecarbam (ISO); N-ethoxycarbonyl-N-methylcarbamoylmethyl O, O-diethyl phosphorodithioate
219-993-9
2595-54-2
Acute Tox. 3
medinoterb acetate (ISO); 6-tert-butyl-3-methyl-2,4-dinitrophenyl acetate
219-634-6
2487-01-6
Acute Tox. 3; Acute Tox. 4
mercaptodimethur (ISO); methiocarb (ISO); 3,5-dimethyl-4-methylthiophenyl N-methylcarbamate
217-991-2
2032-65-7
Acute Tox. 3
methyl (S)-(-)-lactate
248-704-9
27871-49-4
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
methyl (±)-lactate;methyl lactate
208-930-0
2155-30-8;547-64-8
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
methyl (±)-lactate;methyl lactate
208-930-0
2155-30-8;547-64-8
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
methyl 2,5-dichlorobenzoate
220-815-7
2905-69-3
Acute Tox. 4; STOT SE 3
methyl-phenylene diamine; diaminotoluene [technical product — reaction mass of 4-methyl-m-phenylene diamine (EC No 202-453-1) and 2-methyl-m-phenylene diamine (EC No 212-513-9)]
246-910-3
25376-45-8
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
methylenediphenyl diisocyanate
247-714-0
26447-40-5
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
methylethylketone peroxide trimer
429-320-2
24748-23-0
Org. Perox. B; Asp. Tox. 1; Skin Irrit. 2; Skin Sens. 1
metribuzin (ISO); 4-amino-6-tert-butyl-3-methylthio-1,2,4-triazin-5(4H)-one; 4-amino-4,5-dihydro-6-(1,1-dimethylethyl)-3-methylthio-1,2,4-triazin-5-one
244-209-7
21087-64-9
Acute Tox. 4
molinate (ISO);S-ethyl 1-perhydroazepinecarbothioate; S-ethyl perhydroazepine-1-carbothioate
218-661-0
2212-67-1
Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1
monosodium 3-cyano-5-fluoro-6-hydroxypyridine-2-olate
429-570-2
213990-58-0
Skin Sens. 1
morfamquat sulfate
-
29873-36-7
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
muscalure; cis-tricos-9-ene
248-505-7
27519-02-4
Skin Sens. 1B
N'-(1,3-dimethylbutylidene)-3-hydroxy-2-naphthohydrazide
435-860-1
214417-91-1
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-(dimethylamino)thioacetamide hydrochloride
435-470-1
27366-72-9
Repr. 1B
N, N-bis(trimethylsilyl)aminopropylmethyldiethoxysilane
445-890-5
201290-01-9
Acute Tox. 4; Skin Sens. 1
N,N'-dimethylbenzidine
-
2810-74-4
Acute Tox. 4
N,N-dimethylbenzene-1,3-diamine
220-623-3
2836-04-6
Acute Tox. 3
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-(n-octyl)-2-pyrrolidone
NOP; SURFADONE LP-100 SURFACTANT
403-700-8
2687-94-7
Skin Corr. 1B
N-amidino-N-methylglycine-2-oxopropionate
429-120-5
208535-04-0
Eye Dam. 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-hexyllithium
N-HEXYLLITHIUM
404-950-0
21369-64-2
Water-react. 1; Pyr. Sol. 1; Skin Corr. 1A
N-methylbenzene-1,2-diammonium hydrogen phosphate
424-460-0
283167-56-6
Acute Tox. 4; Skin Sens. 1
N5,N5-diethyltoluene-2,5-diamine monohydrochloride; 4-diethylamino-2-methylaniline monohydrochloride
218-130-3
2051-79-8
Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
nickel arsenide
248-169-1
27016-75-7
Carc. 1A; STOT RE 1; Skin Sens. 1
nickel hexafluorosilicate
247-430-7
26043-11-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
nickel isooctanoate
248-585-3
27637-46-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
nickel(II) isooctanoate
249-555-2
29317-63-3
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
nickel(II) silicate
244-578-4
21784-78-1
Carc. 1A; STOT RE 1; Skin Sens. 1
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