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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
1-vinylimidazole
214-012-0
1072-63-5
Repr. 1B
yes
2-(4-tert-butylbenzyl)propionaldehyde
201-289-8
80-54-6
Repr. 1B
2-[2-hydroxy-3-(2-chlorophenyl)carbamoyl-1-naphthylazo]-7-[2-hydroxy-3-(3-methylphenyl)carbamoyl-1-naphthylazo]fluoren-9-one
P-964
420-580-2
151798-26-4
Repr. 1B
2-benzyl-2-dimethylamino-4'-morpholinobutyrophenone
CG 25-369; IRGACURE 369; TK 11-319
404-360-3
119313-12-1
Repr. 1B
yes
2-methylimidazole
211-765-7
693-98-1
Repr. 1B
yes
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
BBP; benzyl butyl phthalate e
201-622-7
85-68-7
Repr. 1B
yes
bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme
205-594-7
143-24-8
Repr. 1B
yes
bis(2-ethylhexyl) phthalate; di-(2-ethylhexyl) phthalate; DEHP
204-211-0
117-81-7
Repr. 1B
yes
bis(2-methoxyethyl) phthalate
204-212-6
117-82-8
Repr. 1B
yes
boric acid
234-343-4
11113-50-1
Repr. 1B
yes
boric acid
233-139-2
10043-35-3
Repr. 1B
yes
di-n-pentyl phthalate
205-017-9
131-18-0
Repr. 1B
yes
diboron trioxide; boric oxide
215-125-8
1303-86-2
Repr. 1B
yes
dibutyl phthalate; DBP
201-557-4
84-74-2
Repr. 1B
yes
dihexyl phthalate
201-559-5
84-75-3
Repr. 1B
yes
diisobutyl phthalate
201-553-2
84-69-5
Repr. 1B
yes
diisohexyl phthalate
276-090-2
71850-09-4
Repr. 1B
yes
diisooctyl phthalate
248-523-5
27554-26-3
Repr. 1B
diisopentylphthalate
210-088-4
605-50-5
Repr. 1B
yes
diphenylether; octabromo derivate
251-087-9
32536-52-0
Repr. 1B
disodium octaborate anhydrous
234-541-0
12008-41-2
Repr. 1B
yes
disodium octaborate tetrahydrate
602-894-3
12280-03-4
Repr. 1B
disodium tetraborate decahydrate; borax decahydrate
603-411-9
1303-96-4
Repr. 1B
yes
Disodium tetraborate pentahydrate
601-808-1
12179-04-3
Repr. 1B
yes
disodium tetraborate, anhydrous; boric acid, disodium salt
215-540-4
1330-43-4
Repr. 1B
yes
ethanol, 2,2'-iminobis-, N-(C13-15-branched and linear alkyl) derivs.
308-208-6
97925-95-6
Repr. 1B
fluazifop-butyl (ISO); butyl (RS)-2-[4-(5-trifluoromethyl-2-pyridyloxy)phenoxy]propionate
274-125-6
69806-50-4
Repr. 1B
flumioxazin (ISO); 2-[7-fluoro-3-oxo-4- (prop-2-yn-1-yl)-3,4-dihydro-2H-1,4-benzoxazin-6-yl]-4,5,6,7-tetrahydro-1H-isoindole-1,3 (2H)-dione
600-425-7
103361-09-7
Repr. 1B
formamide
200-842-0
75-12-7
Repr. 1B
yes
halosulfuron-methyl (ISO); methyl 3-chloro-5-{[(4,6-dimethoxypyrimidin-2-yl)carbamoyl]sulfamoyl}-1-methyl-1H-pyrazole-4-carboxylate
600-130-3
100784-20-1
Repr. 1B
N, N-(dimethylamino)thioacetamide hydrochloride
435-470-1
27366-72-9
Repr. 1B
N-ethyl-2-pyrrolidone; 1-ethylpyrrolidin-2-one
220-250-6
2687-91-4
Repr. 1B
N-methylacetamide
201-182-6
79-16-3
Repr. 1B
yes
n-pentyl-isopentylphthalate
-
-
Repr. 1B
orthoboric acid, sodium salt
237-560-2
13840-56-7
Repr. 1B
reaction mass of: disodium 4-(3-ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5-hydroxy-1-(4-sulfonatophenyl)pyrazol-4-yl)penta-2,4-dienylidene)-4,5-dihydro-5-oxopyrazol-1-yl)benzenesulfonate; trisodium 4-(3-ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5-oxido-1-(4-sulfonatophenyl)pyrazol-4-yl)penta-2,4-dienylidene)-4,5-dihydro-5-oxopyrazol-1-yl)benzenesulfonate
DYE K
402-660-9
-
Repr. 1B
tetraboron disodium heptaoxide, hydrate
235-541-3
12267-73-1
Repr. 1B
yes
tris(2-methoxyethoxy)vinylsilane; 6-(2-methoxyethoxy)-6-vinyl-2,5,7,10-tetraoxa-6-silaundecane
213-934-0
1067-53-4
Repr. 1B
trixylyl phosphate
246-677-8
25155-23-1
Repr. 1B
yes
3-(3-biphenyl-4-yl-1,2,3,4-tetrahydro-1-naphthyl)-4-hydroxycoumarin; difenacoum
259-978-4
56073-07-5
Repr. 1B; Acute Tox. 1; STOT RE 1
bromadiolone (ISO); 3-[3-(4'-bromobiphenyl-4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxy-2H-chromen-2-one
249-205-9
28772-56-7
Repr. 1B; Acute Tox. 1; STOT RE 1
chlorophacinone (ISO); 2-(2-(4-chlorophenyl)phenylacetyl)indan-1,3-dione
223-003-0
3691-35-8
Repr. 1B; Acute Tox. 1; STOT RE 1
difethialone (ISO); 3-[3-(4'-bromobiphenyl-4-yl)-1,2,3,4-tetrahydronaphthalen-1-yl]-4-hydroxy-2H-1-benzothiopyran-2-one
600-594-7
104653-34-1
Repr. 1B; Acute Tox. 1; STOT RE 1
flocoumafen (ISO); reaction mass of: cis-4-hydroxy-3-(1,2,3,4-tetrahydro-3-(4-(4-trifluoromethylbenzyloxy)phenyl)-1-naphthyl)coumarin; trans-4-hydroxy-3-(1,2,3,4-tetrahydro-3-(4-(4-trifluoromethylbenzyloxy)phenyl)-1-naphthyl)coumarin
FLOCOUMAFEN
421-960-0
90035-08-8
Repr. 1B; Acute Tox. 1; STOT RE 1
dinoterb (ISO); 2-tert-butyl-4,6-dinitrophenol
215-813-8
1420-07-1
Repr. 1B; Acute Tox. 2; Acute Tox. 3
salts and esters of dinoterb
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2-tert-butyl-4,6-dinitrophenyl acetate EC / List no: 221-706-7 | CAS no: 3204-27-1
-
-
Repr. 1B; Acute Tox. 2; Acute Tox. 3
coumatetralyl; 4-hydroxy-3-(1,2,3,4-tetrahydro-1-naphthyl)coumarin
227-424-0
5836-29-3
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
pyrithione zinc; (T-4)-bis[1-(hydroxy-κO)pyridine-2(1H)-thionato-κS]zinc
236-671-3
13463-41-7
Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Dam. 1
dichlorodioctyl stannane
222-583-2
3542-36-7
Repr. 1B; Acute Tox. 2; STOT RE 1
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