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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
4-[4-amino-5-hydroxy-3-(4-(2-sulfoxyethylsulfonyl)phenylazo)-2,7-disulfonapht-6-ylazo]-6-[3-(4-amino-5-hydroxy-3-(4-(2-sulfoxyethylsulfonyl)phenylazo)-2,7-disulfonapht-6-ylazo]phenylcarbonylamino]benzenesulfonic acid, sodium salt
NAVY DER 7850
417-640-5
161935-19-9
Eye Dam. 1; Skin Sens. 1
4-[N-ethyl-N-(2-hydroxyethyl)amino]-1-(2-hydroxyethyl)amino-2-nitrobenzene, monohydrochloride
NITROBLAU; NITROBLUE
407-020-2
132885-85-9
Acute Tox. 4; Skin Sens. 1
4-amino-2-(aminomethyl)phenol dihydrochloride
OXAMITOL
412-510-4
135043-64-0
Acute Tox. 4; Skin Sens. 1
4-amino-3-[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-1-naphthalene sulfonic acid
427-680-5
188907-52-0
Eye Dam. 1; Skin Sens. 1
4-amino-3-fluorophenol
FAP
402-230-0
399-95-1
Carc. 1B; Acute Tox. 4; Skin Sens. 1
4-amino-N,N-diethylaniline; N,N-diethyl-p-phenylendiamine
202-214-1
93-05-0
Acute Tox. 3; Skin Corr. 1B
4-amino-N,N-dimethylaniline; 3-amino-N,N'-dimethylaniline
202-807-5
99-98-9
Acute Tox. 3
4-aminoazobenzene; 4-phenylazoaniline
200-453-6
60-09-3
Carc. 1B
yes
4-aminophenol
204-616-2
123-30-8
Muta. 2; Acute Tox. 4
4-benzyl-2,6-dihydroxy-4-aza-heptylene bis (2,2-dimethyloctanoate)
VMZ95005
418-100-1
172964-15-7
Skin Sens. 1
4-bromo-2-chlorofluorobenzene
4-BROM-2-CHLORFLUORBENZOL; 4-BROMO-2-CHLOROFLUOROBENZENE
405-580-2
60811-21-4
Acute Tox. 4; Skin Irrit. 2
4-chloro-3,5-dimethylphenol
201-793-8
88-04-0
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
4-chloro-o-cresol; 4-chloro-2-methylphenol
216-381-3
1570-64-5
Acute Tox. 3; Skin Corr. 1A
4-chloro-o-toluidine
202-441-6
95-69-2
Carc. 1B; Muta. 2; Acute Tox. 3
4-chloro-o-toluidine hydrochloride
221-627-8
3165-93-3
Carc. 1B; Muta. 2; Acute Tox. 3
4-chloroaniline
203-401-0
106-47-8
Carc. 1B; Acute Tox. 3; Skin Sens. 1
4-chlorobutyl veratrate
CHLORO ESTER; CHLOROESTER
410-950-1
69788-75-6
Skin Sens. 1
4-chlorophenol
203-402-6
106-48-9
Acute Tox. 4
4-chlorophenyl cyclopropyl ketone O-(4-aminobenzyl)oxime
ACC ETHER
405-260-2
94050-51-8
Acute Tox. 4; Skin Sens. 1
4-chlorophenylisocyanate
203-176-9
104-12-1
Acute Tox. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1
4-chlorotoluene
203-397-0
106-43-4
Acute Tox. 4
4-CPA (ISO); 4-chlorophenoxyacetic acid
204-581-3
122-88-3
Acute Tox. 4
4-cyclohexyl-2-methyl-2-butanol
CORANOL
420-630-3
83926-73-2
Eye Dam. 1
4-dichloroacetyl-1-oxa-4-azaspiro[4.5]decane
401-130-4
71526-07-3
Skin Sens. 1
4-dimethylaminobenzenediazonium 3-carboxy-4-hydroxybenzenesulfonate
DIAZO-A-SALICYLSULFONATE
404-980-4
124737-31-1
Self-react. C; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
4-ethoxyaniline; p-phenetidine
205-855-5
156-43-4
Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
4-ethyl-2-methyl-2-isopentyl-1,3-oxazolidine
ZOLDINE (R) MS-52
410-470-2
137796-06-6
Skin Corr. 1B; Skin Sens. 1
4-ethylamino-3-nitrobenzoic acid
RO 827
412-090-2
2788-74-1
Acute Tox. 4; Skin Sens. 1
4-fluoro-3-trifluoromethylphenol
432-560-0
61721-07-1
Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
4-formylphenylboronic acid
438-670-5
87199-17-5
Skin Sens. 1
4-Heptylphenol
217-862-0
1987-50-4
yes
4-Heptylphenol, branched and linear
-
-
yes
4-hexadecyl-1-phenylpyrazolidin-3-one
430-840-7
202483-63-4
Skin Sens. 1
4-hydroxy-3-(3-(4'-bromo-4-biphenylyl)-1,2,3,4-tetrahydro-1-naphthyl)coumarin; brodifacoum
259-980-5
56073-10-0
Repr. 1A; Acute Tox. 1; STOT RE 1
4-hydroxy-4-methylpentan-2-one; diacetone alcohol
204-626-7
123-42-2
Eye Irrit. 2
4-hydroxy-7-(2-aminoethyl)-1,3-benzothiazol-2(3H)-one hydrochloride
432-470-1
189012-93-9
Eye Dam. 1; Skin Sens. 1
4-isocyanatosulphonyltoluene; tosyl isocyanate
223-810-8
4083-64-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
4-mesyl-2-nitrotoluene
430-550-0
1671-49-4
Repr. 2; Acute Tox. 4; Skin Sens. 1
4-methoxy-4-methylpentan-2-one
203-512-4
107-70-0
Flam. Liq. 3; Acute Tox. 4
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-methyl-3-oxo-N-phenyl-2-(phenylmethylene)pentanamide
425-860-8
125971-57-5
Skin Sens. 1
4-methyl-8-methylenetricyclo[3.3.1.1 3,7]decan-2-ol
PRISMANTOL
406-330-5
122760-84-3
Skin Irrit. 2; Skin Sens. 1
4-methyl-8-methylenetricyclo[3.3.1.13,7]dec-2-yl acetate
PRISMYLATE
406-560-6
122760-85-4
Skin Irrit. 2; Skin Sens. 1
4-methyl-m-phenylene diisocyanate; toluene-2,6-di-isocyanate
209-544-5
584-84-9
Carc. 2; Acute Tox. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
4-Methyl-m-phenylenediamine; toluene-2,4-diamine;4-methyl-m-phenylenediamine; 2,4-toluenediamine;diaminotoluene, technical product - reaction mass of 4-methyl-m-phenylene diamine and 2-methyl-m-phenylene diamine; methyl-phenylenediamine
202-453-1
95-80-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1
4-Methyl-m-phenylenediamine; toluene-2,4-diamine;4-methyl-m-phenylenediamine; 2,4-toluenediamine;diaminotoluene, technical product - reaction mass of 4-methyl-m-phenylene diamine and 2-methyl-m-phenylene diamine; methyl-phenylenediamine
202-453-1
95-80-7
yes
4-Methyl-m-phenylenediamine; toluene-2,4-diamine;4-methyl-m-phenylenediamine; 2,4-toluenediamine;diaminotoluene, technical product - reaction mass of 4-methyl-m-phenylene diamine and 2-methyl-m-phenylene diamine; methyl-phenylenediamine
202-453-1
95-80-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
4-methyl-N-(methylsulfonyl)benzenesulfonamide
POWDERLINK (R) MTSI
415-040-8
14653-91-9
Acute Tox. 4; STOT SE 3; Eye Dam. 1
4-methylheptane
209-650-1
589-53-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
4-methylpent-3-en-2-one; mesityl oxide
205-502-5
141-79-7
Flam. Liq. 3; Acute Tox. 4
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