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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 maj 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
[(m-tolyloxy)methyl]oxirane
218-575-3
2186-25-6
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
[(tolyloxy)methyl]oxirane; cresyl glycidyl ether
247-711-4
26447-14-3
Muta. 2; Skin Irrit. 2; Skin Sens. 1
[2-[(4-nitrophenyl)amino]ethyl]urea
NITROGELB
410-700-1
27080-42-8
Skin Sens. 1
[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene] dimethylammonium chloride; C.I. Basic Blue 26
219-943-6
2580-56-5
yes
acrylic acid, monoester with propane-1,2-diol
247-118-0
25584-83-2
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
alkenes, C12-14, hydroformylation products, distn. residues, C-(hydrogen sulfobutanedioates), disodium salts
435-660-2
243662-67-1
Skin Irrit. 2; Skin Sens. 1
aluminium phosphide
244-088-0
20859-73-8
Water-react. 1; Acute Tox. 2; Acute Tox. 3; Acute Tox. 1
aminocarb (ISO); 4-dimethylamino-3-tolyl methylcarbamate
217-990-7
2032-59-9
Acute Tox. 3
ammonium 2-cocoyloxyethanesulfonate
441-050-7
223705-57-5
Skin Irrit. 2; Eye Dam. 1
ammonium perfluorooctanesulfonate; ammonium heptadecafluorooctanesulfonate
249-415-0
29081-56-9
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
ammonium salt of DNOC; ammonium 4,6-dinitro-o-tolyl oxide
221-037-0
2980-64-5
Acute Tox. 2; Acute Tox. 1; STOT RE 2
azinphos-ethyl (ISO); O,O-diethyl 4-oxobenzotriazin-3-ylmethyl phosphorodithioate
220-147-6
2642-71-9
Acute Tox. 2; Acute Tox. 3
barium sulphide
244-214-4
21109-95-5
Acute Tox. 4
bendiocarb (ISO); 2,2-dimethyl-1,3-benzodioxol-4-yl N-methylcarbamate
245-216-8
22781-23-3
Acute Tox. 3; Acute Tox. 2
bentazone (ISO);3-isopropyl-2,1,3-benzothiadiazine-4-one-2,2-dioxide
246-585-8
25057-89-0
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
benz[e]acephenanthrylene
205-911-9
205-99-2
Carc. 1B
benzenesulfonic acid, 3,3'-(methylenebis((dihydroxyphenylene)azo)) bis-, potassium sodium salt; potassium sodium 3-[(E)-(6{3,4-dihydroxy-2-}(Z)-(3-sulfonatophenyl)diazenyl]benzyl}-2,3-dihydroxyphenyl)diazenyl]benzenesulfonate
HWL-158
432-590-4
243869-48-9
Eye Irrit. 2
benzo[j]fluoranthene
205-910-3
205-82-3
Carc. 1B
benzo[k]fluoranthene
205-916-6
207-08-9
Carc. 1B
yes
benzophenone-3,3',4,4'-tetracarboxylic dianhydride; 4,4'-carbonyldi(phthalic anhydride)
219-348-1
2421-28-5
Eye Irrit. 2; STOT SE 3
benzyl 2,4-dibromobutanoate
B2,4DBB
420-710-8
23085-60-1
Repr. 2; Skin Irrit. 2; Skin Sens. 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
bromophos (ISO); O-4-bromo-2,5-dichlorophenyl O,O-dimethyl phosphorothioate
218-277-3
2104-96-3
Acute Tox. 4
butyl glycidyl ether; butyl 2,3-epoxypropyl ether
219-376-4
2426-08-6
Flam. Liq. 3; Carc. 2; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Sens. 1
C.I. Disperse Yellow 3; N-[4-[(2-hydroxy-5-methylphenyl)azo]phenyl]acetamide
220-600-8
2832-40-8
Carc. 2; Skin Sens. 1
cadmium hydroxide; cadmium dihydroxide
244-168-5
21041-95-2
Carc. 1B; Muta. 1B; Acute Tox. 4; STOT RE 1
yes
calcium sulphide
243-873-5
20548-54-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
captafol (ISO);1,2,3,6-tetrahydro-N-(1,1,2,2- tetrachloroethylthio)phthalimide
219-363-3
2425-06-1
Carc. 1B; Skin Sens. 1
chlormephos (ISO); S-chloromethyl O,O-diethyl phosphorodithioate
246-538-1
24934-91-6
Acute Tox. 1; Acute Tox. 2
chlorodinitrobenzene
247-109-1
25567-67-3
Acute Tox. 3; STOT RE 2
chlorophenol
246-691-4
25167-80-0
Acute Tox. 4
chlorotoluene
246-698-2
25168-05-2
Acute Tox. 4
chlorpyrifos (ISO); O,O-diethyl O-3,5,6-trichloro-2-pyridyl phosphorothioate
220-864-4
2921-88-2
Acute Tox. 3
chlorthiophos (ISO) [isomeric reaction mass in which O-2,5-dichlorophenyl-4-methylthiophenyl O, O-diethyl phosphorothioate predominates]
244-663-6
21923-23-9
Acute Tox. 2; Acute Tox. 3
chrysene
205-923-4
218-01-9
Carc. 1B; Muta. 2
yes
cinerin I; 3-(but-2-enyl)-2-methyl-4- oxocyclopent-2-enyl 2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate
246-948-0
25402-06-6
Acute Tox. 4
citric acid, nickel salt
245-119-0
22605-92-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
clothianidin (ISO); 3-[(2-chloro-1,3-thiazol-5-yl)methyl]-2-methyl-1-nitroguanidine
433-460-1
210880-92-5
Acute Tox. 4
copper dihydroxide; copper(II) hydroxide
243-815-9
20427-59-2
Acute Tox. 2; Acute Tox. 4; Eye Dam. 1
crufomate (ISO); 4-tert-butyl-2-chlorophenyl methyl methylphosphoramidate
206-083-1
299-86-5
Acute Tox. 4
cyanazine (ISO);2-(4-chloro-6-ethylamino-1,3,5- triazine-2-ylamino)-2-methylpropionitrile
244-544-9
21725-46-2
Acute Tox. 4
cyanophos (ISO); O-4-cyanophenyl O,O-dimethyl phosphorothioate
220-130-3
2636-26-2
Acute Tox. 4
cyclohexylidene hydroperoxide [> 91 % solution];cyclohexylidene hydroperoxide [≤ 91 % solution]
220-279-4
2699-11-8
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B
cyclohexylidene hydroperoxide [> 91 % solution];cyclohexylidene hydroperoxide [≤ 91 % solution]
220-279-4
2699-11-8
Org. Perox. A; Skin Corr. 1B; Acute Tox. 4
cyclopentane
206-016-6
287-92-3
Flam. Liq. 2
cyclopentyl 2-phenylethyl ether
428-340-9
238088-70-5
Skin Irrit. 2
d-carvone; (5S)-2-methyl-5- (prop-1-en-2-yl)cyclohex-2-en- 1-one
218-827-2
2244-16-8
Skin Sens. 1
demephion-S (ISO); O, O-dimethyl S-2-methylthioethyl phosphorothioate
219-971-9
2587-90-8
Acute Tox. 2; Acute Tox. 3
demeton-O (ISO); O,O-diethyl-O-2-ethylthioethyl phosphorothioate
206-053-8
298-03-3
Acute Tox. 1; Acute Tox. 2
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