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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
bifenazate (ISO); isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinecarboxylate
442-820-5
149877-41-8
STOT RE 2; Skin Sens. 1
bifenthrin (ISO); (2-methylbiphenyl-3-yl)methylrel-(1R,3R)-3-[(1Z)-2-chloro-3,3,3-trifluoroprop-1-en-1-yl]-2,2-dimethylcyclopropanecarboxylate
617-373-6
82657-04-3
Carc. 2; Acute Tox. 3; Acute Tox. 2; STOT RE 1; Skin Sens. 1B
binapacryl (ISO); 2-sec-butyl-4,6-dinitrophenyl-3-methylcrotonate
207-612-9
485-31-4
Repr. 1B; Acute Tox. 4
biphenyl-2-ylamine
201-990-9
90-41-5
Carc. 2; Acute Tox. 4
biphenyl-3,3', 4,4'-tetrayltetraamine; diaminobenzidine
202-110-6
91-95-2
Carc. 1B; Muta. 2
biphenyl-4-ylamine; xenylamine; 4-aminobiphenyl
202-177-1
92-67-1
Carc. 1A; Acute Tox. 4
yes
biphenyl; diphenyl
202-163-5
92-52-4
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
bis(1,1-dimethyl-2-propynyloxy)dimethylsilane
PLR-22; XC95-A0638
414-960-7
53863-99-3
Acute Tox. 4
bis(1,2,3-trithiacyclohexyldimethylammonium) oxalate; thiocyclam-oxalate
250-859-2
31895-22-4
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(2,4,6-trinitrophenyl)amine; hexyl
205-037-8
131-73-7
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2
bis(2,6-dimethoxybenzoyl)-2,4,4-trimethylpentylphosphinoxide
CGI 403
412-010-6
145052-34-2
Skin Sens. 1
bis(2-(2-methoxyethoxy)ethyl)ether; tetraglyme
205-594-7
143-24-8
Repr. 1B
yes
bis(2-chloroethyl) ether
203-870-1
111-44-4
Carc. 2; Acute Tox. 2; Acute Tox. 1
bis(2-dimethylaminoethyl)(methyl)amine
221-201-1
3030-47-5
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
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) phthalate; di-(2-ethylhexyl) phthalate; DEHP
204-211-0
117-81-7
Repr. 1B
yes
bis(2-ethylhexyl)-4,5-epoxycyclohexane-1,2-dicarboxylate
430-700-5
10138-36-0
Skin Sens. 1
bis(2-methoxyethyl) ether
203-924-4
111-96-6
Flam. Liq. 3; Repr. 1B
yes
bis(2-methoxyethyl) phthalate
204-212-6
117-82-8
Repr. 1B
yes
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(3-(trimethoxysilyl)propyl)amine
280-084-5
82985-35-1
Eye Dam. 1
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-hydroxy-N-methylanilinium) sulphate
200-237-1
55-55-0
Acute Tox. 4; STOT RE 2; Skin Sens. 1
bis(4-methylbenzoyl)peroxide
INTEROX-PMBP-70W; INTEROX-PMPB-70W
407-950-9
895-85-2
Org. Perox. B
bis(8-hydroxyquinolinium) sulphate
205-137-1
134-31-6
Acute Tox. 4
bis(chloromethyl) ether; oxybis(chloromethane)
208-832-8
542-88-1
Flam. Liq. 2; Carc. 1A; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4
bis(d-gluconato-O1,O2)nickel
276-205-6
71957-07-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
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(hydroxylammonium) sulfate; hydroxylamine sulfate (2:1)
233-118-8
10039-54-0
Met. Corr. 1; Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 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-hydroxy-N-nitrosocyclohexylaminato-O,O')copper; bis(N-cyclohexyl-diazenium-dioxy)-copper; [Cu-HDO]
608-595-4
312600-89-8
Flam. Sol. 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1
bis(N-hydroxy-N-nitrosocyclohexylaminato-O,O')copper; bis(N-cyclohexyl-diazenium-dioxy)-copper; [Cu-HDO]
239-703-4
15627-09-5
Flam. Sol. 1; Acute Tox. 4; STOT RE 2; Eye Dam. 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(pentabromophenyl) ether; decabromodiphenyl ether; DecaBDE
214-604-9
1163-19-5
yes
bis(piperidinothiocarbonyl) disulphide
202-328-1
94-37-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Bis(tributyltin)oxide; TBTO
200-268-0
56-35-9
yes
bis(α,α-dimethylbenzyl) peroxide
201-279-3
80-43-3
Org. Perox. F; Repr. 1B; Skin Irrit. 2; Eye Irrit. 2
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-[4-(2,3-epoxipropoxi)phenyl]propane
216-823-5
1675-54-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 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
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