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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 25 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-dimethoxybutylamine
AMINOBUTYRALDEHYDE DIMETHYL ACETAL
407-690-6
19060-15-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
4-(1(or 4 or 5 or 6)-methyl-8,9,10-trinorborn-5-en-2- yl)pyridine, reaction mass of isomers
ORRINIFF
402-520-7
125352-06-9
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
4-(1,1,3,3-tetramethylbutyl)phenol; 4-tert-octylphenol
205-426-2
140-66-9
Skin Irrit. 2; Eye Dam. 1
yes
4-(2-chloro-4-trifluoromethyl)phenoxy-2-fluoroaniline hydrochloride
WL 125892
402-190-4
113674-95-6
STOT RE 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
4-(2-cyano-3-phenylamino acryloyloxymethyl)-cyclohexyl-methyl 2-cyano-3-phenylamino)-acrylate
LICHTSCHUTZMITTEL 1071
413-510-7
147374-67-2
STOT RE 2; Skin Sens. 1
4-(2-methylacryloyloxy)phenyl4-allyloxybenzoate
4-ALLYLOXYBENZOESÄURE-(4-METHACRYLOYL)PHENYLESTER
429-000-2
159235-16-2
Skin Sens. 1
4-(3,4-dichlorophenylazo)-2,6-di-sec-butyl-phenol
MORTRACE ST CONC.
410-600-8
124719-26-2
STOT RE 2; Skin Irrit. 2
4-(3,5-dimethylheptan-3-yl)phenol
635-389-1
186825-36-5
yes
4-(3,6-dimethylheptan-3-yl)phenol
635-391-2
142731-63-3
yes
4-(3-ethylheptan-2-yl)phenol
635-696-0
186825-39-8
yes
4-(4,4-dimethyl-3-oxo-pyrazolidin-1-yl)-benzoic acid
CARBODIM
413-120-7
107144-30-9
Acute Tox. 4
4-(4-nitrophenylazo)-2,6-di-sec-butyl-phenol
MORTRACE SB CONC.
410-610-2
111850-24-9
STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
4-[(3-chlorophenyl)(1H-imidazol-1-yl)methyl]-1,2-benzenediamine dihydrochloride
425-030-5
159939-85-2
Repr. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
4-[2-(1-methyl-2-(4-morpholinyl)ethoxy)ethyl]morpholine
M.E.M.P.E.
407-940-4
111681-72-2
Eye Dam. 1
4-[3-(diethoxymethylsilylpropoxy)-2,2,6,6-tetramethyl]piperidine
PSL 6
411-400-3
102089-33-8
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
4-[4-(1,3-dihydroxyprop-2-yl)phenylamino]-1,8-dihydroxy-5-nitroanthraquinone
ANTHRACHINON BLAU 27 HD
406-057-1
114565-66-1
Carc. 2; Skin Sens. 1
4-[4-(2-ethylhexyloxy)phenyl](1,4-thiazinane-1,1-dioxide)
CIN 10097929
418-320-8
133467-41-1
Acute Tox. 4
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-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-chloro-o-cresol; 4-chloro-2-methylphenol
216-381-3
1570-64-5
Acute Tox. 3; Skin Corr. 1A
4-chloroaniline
203-401-0
106-47-8
Carc. 1B; Acute Tox. 3; Skin Sens. 1
4-chlorophenol
203-402-6
106-48-9
Acute Tox. 4
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-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-Heptylphenol
217-862-0
1987-50-4
yes
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-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-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-N-(methylsulfonyl)benzenesulfonamide
POWDERLINK (R) MTSI
415-040-8
14653-91-9
Acute Tox. 4; STOT SE 3; Eye Dam. 1
4-methylpent-3-en-2-one; mesityl oxide
205-502-5
141-79-7
Flam. Liq. 3; Acute Tox. 4
4-methylpentan-2-ol; methyl isobutyl carbinol
203-551-7
108-11-2
Flam. Liq. 3; STOT SE 3
4-methylpentan-2-one; isobutyl methyl ketone
203-550-1
108-10-1
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
4-methylpyridine; 4-picoline
203-626-4
108-89-4
Flam. Liq. 3; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
4-nitrophenol; p-nitrophenol
202-811-7
100-02-7
Acute Tox. 4; STOT RE 2
4-nitrosophenol
203-251-6
104-91-6
Muta. 2; Acute Tox. 4; Eye Dam. 1
4-Nonylphenol, branched, ethoxylated (1 - 2.5 moles ethoxylated)
1 - 2.5 moles ethoxylated
500-315-8
127087-87-0
yes
4-nonylphenol, reaction products with formaldehyde and dodecane-1-thiol
POLYSTAY K; WINGSTAY K
404-160-6
164907-73-7
Skin Sens. 1
4-oxo-4-(p-tolyl)butyric acid adduct with 4-ethylmorpholine
419-240-6
171054-89-0
Eye Dam. 1
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