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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
mix-cresol
215-293-2
1319-77-3
Acute Tox. 3; Skin Corr. 1B
o-cresol
202-423-8
95-48-7
Acute Tox. 3; Skin Corr. 1B
p-cresol
203-398-6
106-44-5
Acute Tox. 3; Skin Corr. 1B
potassium bifluoride; potassium hydrogen difluoride
232-156-2
7789-29-9
Acute Tox. 3; Skin Corr. 1B
sodium bifluoride; sodium hydrogen difluoride
215-608-3
1333-83-1
Acute Tox. 3; Skin Corr. 1B
sodium polysulphides
215-686-9
1344-08-7
Acute Tox. 3; Skin Corr. 1B
thioglycolic acid
200-677-4
68-11-1
Acute Tox. 3; Skin Corr. 1B
xylenol
215-089-3
1300-71-6
Acute Tox. 3; Skin Corr. 1B
2-chloro-5-chloromethylthiazole
2-CHLORO-5-CHLOROMETHYLTHIAZOLE
429-830-5
105827-91-6
Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
3,5-dichloro-2,4-difluorobenzoyl fluoride
3,5-DICHLORO-2,4-DIFLUOROBENZOYLFLUORIDE
401-800-6
101513-70-6
Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
hexachloroplatinic acid
241-010-7
16941-12-1
Acute Tox. 3; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
2,3-epoxypropyl acrylate; glycidyl acrylate
203-440-3
106-90-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
2-hydroxy-1-methylethylacrylate
220-852-9
2918-23-2
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
2-hydroxyethyl acrylate
212-454-9
818-61-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
2-hydroxypropylacrylate
213-663-8
999-61-1
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
acrylic acid, monoester with propane-1,2-diol
247-118-0
25584-83-2
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
C8-18 alkylbis(2-hydroxyethyl)ammonium bis(2-ethylhexyl)phosphate
INTERSEPT
404-690-8
68132-19-4
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
methyl isothiocyanate
209-132-5
556-61-6
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
pyraclostrobin (ISO); methyl N-{2-[1-(4-chlorophenyl)-1H-pyrazol-3-yloxymethyl]phenyl}(N-methoxy)carbamate
605-747-1
175013-18-0
Acute Tox. 3; Skin Irrit. 2
sodium salt of chloroacetic acid; sodium chloroacetate
223-498-3
3926-62-3
Acute Tox. 3; Skin Irrit. 2
diammonium tetrachloroplatinate
237-499-1
13820-41-2
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
dipotassium tetrachloroplatinate
233-050-9
10025-99-7
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
disodium tetrachloroplatinate
233-051-4
10026-00-3
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
esfenvalerate (ISO); (S)-α-cyano-3-phenoxybenzyl-(S)-2-(4-chlorophenyl)-3-methylbutyrate
613-911-9
66230-04-4
Acute Tox. 3; Skin Sens. 1
hexakis(tetramethylammonium) 4,4'-vinylenebis((3-sulfonato-4,1-phenylene)imino(6- morpholino-1,3,5-triazine-4,2- diyl)imino)bis(5-hydroxy-6-phenylazonaphthalene-2,7- disulfonate)
DIRECT RED 227, TETRAMETHYLAMMONIUM SALT
405-160-9
124537-30-0
Acute Tox. 3; Skin Sens. 1
tetrakis(tetramethylammonium); 6-amino-4-hydroxy-3-(7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo)naphthalene-2,7-disulfonate
FOOD BLACK 2, TETRAMETHYLAMMONIUM SALT
405-170-3
116340-05-7
Acute Tox. 3; Skin Sens. 1
(3S,4aS,8aS)-2-[(2R,3S)-3-amino-2-hydroxy-4-phenylbutyl]-N-tert-butyldecahydroisoquinoline-3-carboxamide
PTH-AA
430-230-0
136522-17-3
Acute Tox. 4
(R)-1,2,3,4-tetrahydro-6,7-dimethoxy-1-veratrylisoquinoline hydrochloride
R-THP
415-110-8
54417-53-7
Acute Tox. 4
(R)-1-cyclohexa-1,4-dienyl-1-methoxycarbonyl-methylammoniumchloride
444-320-2
-
Acute Tox. 4
(S)-N-tert-butyl-1,2,3,4-tetrahydro-3-isoquinolinecarboxamide
CZ-AMIDE; PTH-TETRAHYDROAMIDE; TETRAHYDROAMIDE (THA)
414-600-9
149182-72-9
Acute Tox. 4
(Z)-2-(2-t-butoxycarbonylamino-4-thiazolyl)pent-2-enoic acid
430-100-3
86978-24-7
Acute Tox. 4
(η-cumene)-(η-cyclopentadienyl)iron(II) trifluoromethane-sulfonate
CG 26-751
407-880-9
117549-13-0
Acute Tox. 4
1,1,1-trichloroethane; methyl chloroform
200-756-3
71-55-6
Acute Tox. 4
1,1-dimethylpiperidinium chloride; mepiquat chloride
246-147-6
24307-26-4
Acute Tox. 4
1,2,3,4-tetrahydro-6-nitro-quinoxaline
RO 1173
414-270-6
41959-35-7
Acute Tox. 4
1,2-diacetoxybut-3-ene
3,4-DIACETOXY-1-BUTENE
421-720-5
18085-02-4
Acute Tox. 4
1,2-dimethyl-3,5-diphenylpyra zolium methylsulphate; difenzoquat methyl sulfate
256-152-5
43222-48-6
Acute Tox. 4
1,3-dichlorbenzene
208-792-1
541-73-1
Acute Tox. 4
1,4-dihydroxy-2,2,6,6-tetramethyl piperidinium-2-hydroxy-1,2,3-propanetricarboxylate
429-370-5
220410-74-2
Acute Tox. 4
1,7,7-trimethylbicyclo(2,2,1)hept-2-yl thiocyanatoacetate; isobornyl thiocyanoacetate
204-081-5
115-31-1
Acute Tox. 4
1-(2-butoxypropoxy)propan-2-ol
246-011-6
24083-03-2
Acute Tox. 4
1-benzyl-5-ethoxyimidazolidine-2,4-dione
BEH; FC-05; FCO5; WMT 1155
417-340-4
65855-02-9
Acute Tox. 4
1-benzylimidazolidine-2,4-dione
T-5914 AND 501006025007
421-340-1
6777-05-5
Acute Tox. 4
1-butyl-2-methylpyridinium bromide
ENS 119
402-680-8
26576-84-1
Acute Tox. 4
1-chloro-1-nitropropane
209-990-0
600-25-9
Acute Tox. 4
1-ethoxy-2,3-difluorobenzene
1-ETHOXY-2,3-DIFLUORBENZOL; 1-ETHOXY-2,3-DIFLUOROBENZENE; 2,3-DIFLUOROPHENETOL; DIPHOL
441-000-4
121219-07-6
Acute Tox. 4
1-ethyl-5,6,7,8-tetrahydroquinolinium tosylate
419-570-0
195006-58-7
Acute Tox. 4
1-methyl-4-(2-methyl-2H-tetrazol-5-yl)-1H-pyrazole-5-sulfonamide
424-160-1
139481-22-4
Acute Tox. 4
1-naphthylamine
205-138-7
134-32-7
Acute Tox. 4
1-phenyl-3-pyrazolidone
202-155-1
92-43-3
Acute Tox. 4
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