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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
acibenzolar-S-methyl; benzo[1,2,3]thiadiazole-7-carbothioic acid S-methyl ester
CGA 245704 TECH.
420-050-0
135158-54-2
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
acrylic acid, 3-(trimethoxysilyl)propyl ester
419-560-6
4369-14-6
Acute Tox. 4; 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
alkyl(rapeseed oil), bis(2-hydroxyethyl)ammonium fluoride
435-650-8
-
Acute Tox. 4; Skin Corr. 1A
ammonium (Z)-α-methoxyimino-2-furylacetate
640 AMMONIUM SALT; KSMIA; S-102; SMIA
405-990-1
97148-39-5
Flam. Sol. 1
ammonium 2-cocoyloxyethanesulfonate
441-050-7
223705-57-5
Skin Irrit. 2; Eye Dam. 1
ammonium bis(1-(3,5-dinitro-2-oxidophenylazo)-3-(N-phenylcarbamoyl)-2-naphtholato)chromate(1-)
AIZEN SPILON BLACK TRH; AIZEN SPILON SCHWARZ TRH; THR-1; TRH
400-110-2
109125-51-1
Self-react. C
androsta-1,4,9(11)-triene-3,17-dione
433-560-3
15375-21-0
Repr. 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
behenamidopropyl-dimethyl-(dihydroxypropyl) ammonium chloride
LEXQUAT AMG-BEO (CONCENTRATE)
423-420-1
136920-10-0
Eye Dam. 1; Skin Sens. 1
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
benzoic acid, N-tert-butyl-N'-(4-chlorobenzoyl)hydrazide
431-600-4
112226-61-6
Skin Sens. 1
benzyl 2,4-dibromobutanoate
B2,4DBB
420-710-8
23085-60-1
Repr. 2; Skin Irrit. 2; Skin Sens. 1
benzyl [hydroxy-(4-phenylbutyl)phosphinyl] acetate
SQ 28,355; SQ 28355
416-050-5
87460-09-1
Eye Dam. 1
benzyl(S)-2-[(2'-cyanobiphenyl-4-ylmethyl)pentanoylamino]-3-methylbutyrate
427-470-3
137864-22-3
Acute Tox. 4; Skin Sens. 1
benzyl-2-hydroxydodecyldi; methylammonium benzoate
B 2049
402-610-6
113694-52-3
Skin Corr. 1B; Acute Tox. 4
benzyl-N-(2-(2-methoxyphenoxy)ethyl)amine hydrochloride
BM 96.0258.HCL
428-290-8
120606-08-8
Acute Tox. 4; Eye Dam. 1
benzyldimethyloctadecylammonium 3-nitrobenzenesulfonate
CA10
405-330-2
124088-59-1
Skin Irrit. 2; Eye Dam. 1
benzyltributylammonium 4-hydroxynaphthalene-1-sulphonate
BONTRON P-51
402-240-5
102561-46-6
Acute Tox. 4
bifenazate (ISO); isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinecarboxylate
442-820-5
149877-41-8
STOT RE 2; Skin Sens. 1
bis(1,1-dimethyl-2-propynyloxy)dimethylsilane
PLR-22; XC95-A0638
414-960-7
53863-99-3
Acute Tox. 4
bis(1-methylethyl)-dimethoxysilane
EURENOR 5021; PSX 872
421-540-7
18230-61-0
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
bis(2,2,6,6-tetramethyl-4-piperidyl) succinate
TINUVIN 780
402-940-0
62782-03-0
Eye Irrit. 2
bis(2,4,4-trimethylpentyl)dithiophosphonic acid
420-160-9
107667-02-7
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
bis(2,6-dimethoxybenzoyl)-2,4,4-trimethylpentylphosphinoxide
CGI 403
412-010-6
145052-34-2
Skin Sens. 1
bis(2-ethylhexyl) dithiodiacetate
DI(2-ETHYLHEXYL)DITHIODIGLYKOLAT; DP 327
404-510-8
62268-47-7
Acute Tox. 4; Skin Sens. 1
bis(2-ethylhexyl)-4,5-epoxycyclohexane-1,2-dicarboxylate
430-700-5
10138-36-0
Skin Sens. 1
bis(3,5-di-tert-butylsalicylato-O1,O2)zinc
BONTRON E-84; E-84
403-360-0
42405-40-3
Flam. Sol. 1; Acute Tox. 4
bis(4-(1,2-bis(ethoxycarbonyl)ethylamino)-3-methylcyclohexyl)methane
DESMOPHEN VP-LS 2973 E; DESMOPHEN VP-LS 2975 E; DESMOPHEN VP-LS 2985 E
412-060-9
136210-32-7
Skin Sens. 1
bis(4-dodecylphenyl)iodonium hexafluoroantimonate
404-420-9
71786-70-4
Skin Sens. 1
bis(4-fluorophenyl)-methyl-(1,2,4-triazol-4-ylmethyl)silane hydrochloride
U 9649
401-380-4
89066-61-5
Eye Irrit. 2
bis(4-methylbenzoyl)peroxide
INTEROX-PMBP-70W; INTEROX-PMPB-70W
407-950-9
895-85-2
Org. Perox. B
bis(dimethyl-(2-hydroxyethyl)ammonium) 1,2-ethanediyl-bis(2-hexadecenylsuccinate)
Z-27
421-660-1
-
Eye Dam. 1; Skin Sens. 1
bis(hydrogenated tallow C16-18-alkyl)hydroxylamine
418-370-0
143925-92-2
Skin Sens. 1
bis(N-(7-hydroxy-8-methyl-5-phenylphenazin-3-ylidene)dimethylammonium) sulfate
SAFRANIN SHMN
406-770-8
149057-64-7
STOT RE 2; Eye Dam. 1; Skin Sens. 1
bis(N-methyl-N-phenylhydrazine)sulfate
GR101655A
423-170-1
618-26-8
Flam. Liq. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
bis(η5-cyclopentadienyl)-bis(2,6-difluoro-3-[pyrrol-1-yl]-phenyl)titanium
CGI 784
412-000-1
125051-32-3
Flam. Sol. 1; Repr. 2; STOT RE 2
bis-(6-hydroxy-4-methyl-5-(3-methylimidazolium-1-yl)-3-(4-phenylazo)-1H-pyridin-2-one)ethylene dilactate
421-560-6
-
STOT RE 2; Eye Dam. 1
bis[(1-methylimidazol)-(2-ethyl-hexanoate)], zinc complex
TK 10891; XB 4458; XW 528; ZK XB 4458
405-635-0
-
Skin Irrit. 2; Eye Dam. 1
bis[4-(ethenyloxy)butyl] 1,3-benzenedicarboxylate
VECTOMER E2200
413-930-0
130066-57-8
Skin Sens. 1
bis[[2,2',2''-nitrilotris-[ethanolato]]-1-N,O]-bis[2-(2-methoxyethoxy)ethoxy]-titanium
TITANCHELAT ETAM
410-500-4
357921-97-2
Eye Dam. 1
bis[tributyl 4-(methylbenzyl)ammonium] 1,5-naphthalenedisulfonate
MCP-304
415-210-1
160236-81-7
Acute Tox. 4; Eye Dam. 1
bromobenzylbromotoluene, reaction mass of isomers
DBBT
402-210-1
99688-47-8
STOT RE 2; Skin Sens. 1
butroxydim (ISO); 5-(3-butyryl-2,4,6-trimethylphenyl)-2-[1-(ethoxyimino)propyl]-3-hydroxycyclohex-2-en-1-one
BUTROXYDIM; ICIA0500
414-790-3
138164-12-2
Repr. 2; Acute Tox. 4; Skin Irrit. 2
butyl (dialkyloxy(dibutoxyphosphoryloxy))titanium (trialkyloxy)titanium phosphate
TILCOM CA35; TILCOM IA10; TYTAN AP 100; TYTAN CA 100; TYTAN CX 35; TYZOR IAM
401-100-0
109037-78-7
Flam. Liq. 2; Eye Irrit. 2
C12-14-tert-alkyl ammonium 1-amino-9,10-dihydro-9,10-dioxo-4-(2,4,6-trimethylanilino)-anthracen-2-sulfonate
ORASOL BLAU 761B
414-110-5
1379678-96-2
Eye Dam. 1
C12-14-tert-alkylamine, methylphosphonic acid salt
CD 23-404
404-750-3
119415-07-5
Acute Tox. 4; Skin Corr. 1B
C8-10 alkyl dimethyl hydroxyethyl ammoniumchloride (chain < C8: <3 %, chain = C8: 15 %-70 %, chain = C10: 30 %- 85 %, chain > C10: <3 %)
417-360-3
1379678-84-8
Acute Tox. 4; Skin Irrit. 2
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
calcium 2,2,bis[(5-tetrapropylene-2-hydroxy)phenyl]ethanoate
Z-28
421-670-4
1379765-16-8
Skin Irrit. 2
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