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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 26 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-(1,4-dioxa-spiro[4.5]dec-8-yl)-cyclohexanone
423-860-2
56309-94-5
Skin Sens. 1
4-(1-ethyl-1-methylhexyl)phenol
257-907-1
52427-13-1
yes
4-(1-oxo-2-propenyl)-morpholine
ACRYLOYLMORPHOLIN
418-140-1
5117-12-4
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
4-(2,6-dimethylheptan-2-yl)phenol
635-388-6
521947-27-3
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-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
250-863-4
31906-04-4
Skin Sens. 1A
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-(4-tolyloxy)biphenyl
JKY-120
405-730-7
51601-57-1
STOT RE 2
4-(5-(5-[1-(4-carboxyphenyl)hexahydro-2,4,6-trioxopyrimidin-5-ylidene]penta-1,3-dienyl)-1,2,3,4-tetrahydro-6-hydroxy-2,4-dioxopyrimidin-1-yl)benzoic acid-triethylamine salt
426-900-7
203118-12-1
STOT SE 3
4-(cyanomethyl)-4-methylmorpholin-4-ium hydrogen sulfate
431-200-1
208538-34-5
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
4-(trans-4-propylcyclohexyl)acetophenone
4-(4-PROPYLCYCLOHEXYL)-ACETOPHENON
406-700-6
78531-61-0
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-[(3-hydroxypropyl)amino]-3-nitrophenol
PLAKATROT Z; ROT BN
406-305-9
92952-81-3
Skin Irrit. 2
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-(2,2-dimethyl-propanamido)]phenylazo-3-(2-chloro-5-(2-(3-pentadecylphenoxy)butylamido)anilino)-1-(2,4,6-trichlorophenyl)-2-pyrazoline-5-one
420-220-4
92771-56-7
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-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
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