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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 24 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
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
dichlofluanid (ISO); N-dichlorofluoromethylthio-N',N'-dimethyl-N-phenylsulfamide
214-118-7
1085-98-9
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
mequinol; 4-methoxyphenol; hydroquinone monomethyl ether
205-769-8
150-76-5
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
methyl-2,3,5,6-tetrachloro-4- pyridylsulphone;2,3,5,6-tetrachloro-4-(methylsulphonyl)pyridine
236-035-5
13108-52-6
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
methyl-5-nitrophenyl-guanidine
435-500-1
152460-07-6
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
N, N,N',N'-tetramethyldithiobis(ethylene)diamine dihydrochloride
AF-172; FPC 114
405-300-9
17339-60-5
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
propachlor (ISO); 2-chloro-N-isopropylacetanilide; α-chloro-N-isopropylacetanilide
217-638-2
1918-16-7
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
sodium 4-chloro-1-hydroxybutane-1-sulfonate
BISULPHITE ADDUCT; GR59658A
406-190-5
54322-20-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
tetrapropan-2-yl (dichloromethanediyl)bis(phosphonate)
430-630-5
10596-22-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
pirimiphos-methyl (ISO); O-(2-diethylamino-6-methylpyrimidin-4-yl) O, O-dimethyl phosphorothioate
249-528-5
29232-93-7
Acute Tox. 4; STOT RE 1
maleic anhydride
203-571-6
108-31-6
Acute Tox. 4; STOT RE 1; Skin Corr. 1B; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1A
(4-(1-methylethyl)phenyl)-(4-methylphenyl)iodonium tetrakis(pentafluorophenyl)borate(1-)
PHOTOAMORCEUR 22074; RHODORSIL PHOTOINITIATOR 2074; TEPBI
422-960-3
178233-72-2
Acute Tox. 4; STOT RE 2
1-(2,3-dihydro-1,3,3,6-tetramethyl-1-(1-methylethyl)-1H-inden-5-yl)ethanone
ACYLINDANE
411-180-9
92836-10-7
Acute Tox. 4; STOT RE 2
1-methyl-4-nitro-3-propyl-1H-pyrazole-5-carboxamide
423-960-6
139756-01-7
Acute Tox. 4; STOT RE 2
1-phenyl-3-(p-toluenesulfonyl)urea
TUPH
424-620-1
13909-63-2
Acute Tox. 4; STOT RE 2
2,3-bis((2-mercaptoethyl)thio)-1-propanethiol
MR-7 B; MR-8 B2; MR-S2
411-290-7
131538-00-6
Acute Tox. 4; STOT RE 2
2,6-diamino-3-((pyridine-3-yl)azo)pyridine
AZOGELB
421-430-9
28365-08-4
Acute Tox. 4; STOT RE 2
2-(7-ethyl-1H-indol-3-yl)ethanol
7-ETHYLTRYPTOPHOL
431-020-1
41340-36-7
Acute Tox. 4; STOT RE 2
2-amino-4-dimethylamino-6-trifluoroethoxy-1,3,5-triazine
415-500-8
145963-84-4
Acute Tox. 4; STOT RE 2
2-amino-5-methylthiazole
2-AMINO-5-METHYLTHIAZOL
423-800-5
7305-71-7
Acute Tox. 4; STOT RE 2
2-ethyl-2,3-dihydro-2-methyl-1H-perimidine
424-380-6
43057-68-7
Acute Tox. 4; STOT RE 2
2-thiazolidinylidenecyanamide
427-720-1
26364-65-8
Acute Tox. 4; STOT RE 2
3'-(3-acetyl-4-hydroxyphenyl)-1,1-diethylurea
A1354
411-970-3
79881-89-3
Acute Tox. 4; STOT RE 2
4-methoxy-N,6-dimethyl-1,3,5- triazin-2-ylamine
2-METHOXY-4-METHYL-6-METHYLAMINO-1,3,5-TRIAZIN; DPX-L5296; L5296
401-360-5
5248-39-5
Acute Tox. 4; STOT RE 2
4-nitrophenol; p-nitrophenol
202-811-7
100-02-7
Acute Tox. 4; STOT RE 2
4-{[(6-chloropyridin-3-yl)methyl](2,2-difluoroethyl)amino}furan-2(5H)-one; flupyradifurone
804-373-8
951659-40-8
Acute Tox. 4; STOT RE 2
barium calcium cesium lead samarium strontium bromide chloride fluoride iodide europium doped
431-780-4
199876-46-5
Acute Tox. 4; STOT RE 2
di(tetramethylammonium)(29H,31H-phthalocyanin-N29,N30,N31,N32)disulfonamide disulfonate, cuprate(2-)complex, derivates
DIRECT BLUE 199
416-180-2
12222-04-7
Acute Tox. 4; STOT RE 2
ethyl 2-(1-cyanocyclohexyl)acetate
GABAPENTINE ETHYL ESTER; PD 137016
415-970-4
133481-10-4
Acute Tox. 4; STOT RE 2
ethyl 4-((4-diethylamino-2-methylphenyl)imino)-4,5-dihydro-1-isopropyl-5-oxo-1H-pyrazole-3-carboxylate
427-110-5
948991-29-5
Acute Tox. 4; STOT RE 2
ethyl cis-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine-1-carboxylate
428-030-3
67914-69-6
Acute Tox. 4; STOT RE 2
monolinuron (ISO); 3-(4-chlorophenyl)-1-methoxy-1-methylurea
217-129-5
1746-81-2
Acute Tox. 4; STOT RE 2
pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate
205-391-3
140-01-2
Acute Tox. 4; STOT RE 2
terbuthylazine (ISO); N-tert-butyl-6-chloro-N'-ethyl-1,3,5-triazine-2,4-diamine
227-637-9
5915-41-3
Acute Tox. 4; STOT RE 2
4,4'-ethylidenediphenyl dicyanate
AROCY L-10
405-740-1
47073-92-7
Acute Tox. 4; STOT RE 2; 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
cis-1-(3-(4-fluorophenoxy)propyl)-3-methoxy-4-piperidinamine
425-080-8
104860-26-6
Acute Tox. 4; STOT RE 2; Eye Dam. 1
Reaction mass of: 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-1-octanesulfonic acid; ammonium 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-1-octanesulfonate
432-190-1
182176-52-9
Acute Tox. 4; STOT RE 2; Eye Dam. 1
vanadium(IV) oxide hydrogen phosphate hemihydrate, lithium, zinc, molybdenum, iron and chlorine-doped
424-390-0
93280-40-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1
ethyl 2-(isocyanatosulfonyl)benzoate
EPSI
410-220-2
77375-79-2
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
(R)-3-[(1-methylpyrrolidin-2-yl)methyl]-5-[2-(phenylsulfonyl)ethenyl]-1H-indole
430-560-5
180637-89-2
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
(Z)-1-benzo[b]thien-2-ylethanone oxime hydrochloride
A-83851
410-780-8
1379676-72-8
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
2-acetoxymethylene-4-acetylphenylacetate
425-160-2
24085-06-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
4-(1-oxo-2-propenyl)-morpholine
ACRYLOYLMORPHOLIN
418-140-1
5117-12-4
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
5-acetyl-3-amino-10,11-dihydro-5H-dibenz[b, f]azepine-hydrochloride
5-ACETYL-3-AMINO-IMINODIBENZYL.HCL
410-490-1
138451-65-7
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
potassium 2-chloro-3-(benzyloxy)propionate
KLOBENPROP
426-350-8
138666-92-9
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
pyrazole-1-carboxamidine monohydrochloride
429-520-1
4023-02-3
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
tert-butyl (1R,5S)-3-azabicyclo[3.1.0]hex-6-ylcarbamate
429-170-8
134575-17-0
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
tetraammine palladium (II)hydrogen carbonate
425-270-0
134620-00-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
2,4-diamino-3,5-diethyltoluene; 2,4-diethyl-6-methyl-1,3-benzenediamine
218-256-9
2095-02-5
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
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