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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
benzyl violet 4B; α-[4-(4-dimethylamino-α-{4-[ethyl(3-sodiosulphonato benzyl)amino] phenyl}benzylidene)cyclohexa-2,5-dienylidene(ethyl)ammonio]toluene-3-sulphonate
216-901-9
1694-09-3
Carc. 2
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
benzylamine
202-854-1
100-46-9
Acute Tox. 4; Skin Corr. 1B
benzyldimethylamine
203-149-1
103-83-3
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
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
beryllium oxide
215-133-1
1304-56-9
Carc. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Beta-hexabromocyclododecane
603-802-4
134237-51-7
yes
bifenazate (ISO); isopropyl 2-(4-methoxybiphenyl-3-yl)hydrazinecarboxylate
442-820-5
149877-41-8
STOT RE 2; Skin Sens. 1
bis(1-methylethyl)-dimethoxysilane
EURENOR 5021; PSX 872
421-540-7
18230-61-0
Flam. Liq. 3; Skin Irrit. 2; Skin Sens. 1
bis(2,4,4-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-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(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(8-hydroxyquinolinium) sulphate
205-137-1
134-31-6
Acute Tox. 4
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]
239-703-4
15627-09-5
Flam. Sol. 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1
Bis(pentabromophenyl) ether; decabromodiphenyl ether; DecaBDE
214-604-9
1163-19-5
yes
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-[4-(2,3-epoxipropoxi)phenyl]propane
216-823-5
1675-54-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
bis[4-(ethenyloxy)butyl] 1,3-benzenedicarboxylate
VECTOMER E2200
413-930-0
130066-57-8
Skin Sens. 1
bis[tributyl 4-(methylbenzyl)ammonium] 1,5-naphthalenedisulfonate
MCP-304
415-210-1
160236-81-7
Acute Tox. 4; Eye Dam. 1
Borate(2-), tetrahydroxybis[μ-(peroxy-κO1:κO2)]di-, sodium, hydrate (1:2:6)
-
125022-34-6
yes
boric acid
233-139-2
10043-35-3
Repr. 1B
yes
boric acid
234-343-4
11113-50-1
Repr. 1B
yes
boron tribromide
233-657-9
10294-33-4
Acute Tox. 2; Skin Corr. 1A
boron trichloride
233-658-4
10294-34-5
Press. Gas; Acute Tox. 2; Skin Corr. 1B
bromobenzene
203-623-8
108-86-1
Flam. Liq. 3; Skin Irrit. 2
bromofenoxim (ISO); 3,5-dibromo-4-hydroxybenzaldehyde-O-(2,4-dinitrophenyl)-oxime
236-129-6
13181-17-4
Acute Tox. 4
bromoxynil (ISO) 3,5-dibromo-4-hydroxybenzonitrile; bromoxynil phenol
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3,5-dibromo-4-hydroxybenzonitrile EC / List no: 216-882-7 | CAS no: 1689-84-5
2,6-dibromo-4-cyanophenyl octanoate EC / List no: 216-885-3 | CAS no: 1689-99-2
2,6-dibromo-4-cyanophenyl heptanoate EC / List no: 260-300-4 | CAS no: 56634-95-8
2,6-dibromo-4-cyanophenyl butyrate EC / List no: 223-374-9 | CAS no: 3861-41-4
216-882-7
1689-84-5
Repr. 2; Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
bromoxynil octanoate (ISO); 2,6-dibromo-4-cyanophenyl octanoate
216-885-3
1689-99-2
Repr. 2; Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
but-1-ene
203-449-2
106-98-9
Flam. Gas 1; Press. Gas
but-2-yne-1,4-diol; 2-butyne-1,4-diol
203-788-6
110-65-6
Skin Corr. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1
butane;butane (containing ≥ 0,1 % butadiene (203-450-8))
203-448-7
106-97-8
Flam. Gas 1; Press. Gas; Carc. 1A; Muta. 1B
butane;butane (containing ≥ 0,1 % butadiene (203-450-8))
203-448-7
106-97-8
Flam. Gas 1; Press. Gas
butene, mixed-1-and-2-isomers
203-452-9
107-01-7
Flam. Gas 1; Press. Gas
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
butyl butyrate
203-656-8
109-21-7
Flam. Liq. 3
butylamine
203-699-2
109-73-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
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