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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 27 March 2023. 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'-(oxy-(bismethylene))-bis-1,3-dioxolane
DIGLYCERINDIFORMAL (DGDF)
423-230-7
56552-15-9
Eye Dam. 1
4,4'-bi-o-toluidine
204-358-0
119-93-7
Carc. 1B; Acute Tox. 4
4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol
209-218-2
561-41-1
yes
4,4'-bis(dimethylamino)benzophenone; Michler's ketone
202-027-5
90-94-8
Carc. 1B; Muta. 2; Eye Dam. 1
yes
4,4'-bis(N-carbamoyl-4-methylbenzenesulfonamide)diphenylmethane
B-TUM
418-770-5
151882-81-4
Carc. 2
4,4'-carbonimidoylbis[N, N-dimethylaniline]
207-762-5
492-80-8
Carc. 2; Acute Tox. 4; Eye Irrit. 2
4,4'-diamino-2-methylazobenzene
ZP-DK 2115
407-590-2
43151-99-1
Acute Tox. 3; STOT RE 2; Skin Sens. 1
4,4'-diaminodiphenylmethane; 4,4'-methylenedianiline
202-974-4
101-77-9
Carc. 1B; Muta. 2; STOT SE 1; STOT RE 2; Skin Sens. 1
yes
4,4'-ethylidenediphenyl dicyanate
AROCY L-10
405-740-1
47073-92-7
Acute Tox. 4; STOT RE 2; Eye Dam. 1
4,4'-methylene bis(3-chloro-2,6-di-ethylphenylisocyanate)
420-530-1
177027-34-8
Resp. Sens. 1; Skin Sens. 1
4,4'-methylenebis(2,6-dimethylphenyl cyanate)
AROCY M-10
405-790-4
101657-77-6
Skin Sens. 1
4,4'-methylenebis(2-ethylaniline); 4,4'-methylenebis(2-ethylbenzeneamine)
243-420-1
19900-65-3
Carc. 2; Acute Tox. 4
4,4'-methylenebis(2-isopropyl-6-methylaniline)
LONZACURE M-MIPA
415-150-6
16298-38-7
STOT RE 2
4,4'-methylenebis(N,N'-dimethylcyclohexanamine)
LUPRAGEN VP 9199 X
412-840-9
13474-64-1
Acute Tox. 4; STOT RE 2; Skin Corr. 1A
4,4'-methylenedi(cyclohexyl isocyanate); dicyclohexylmethane-4,4'-di-isocyanate
225-863-2
5124-30-1
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
4,4'-methylenedi-o-toluidine
212-658-8
838-88-0
Carc. 1B; Acute Tox. 4; Skin Sens. 1
yes
4,4'-methylenediphenyl diisocyanate; diphenylmethane-4,4'-diisocyanate
202-966-0
101-68-8
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
4,4'-oxybis(benzenesulfonylazide)
431-850-4
7456-68-0
Expl. 1.1; STOT RE 2
4,4'-oxybis(ethylenethio)diphenol
DD-63
404-590-4
90884-29-0
Skin Sens. 1
4,4'-oxydianiline and its salts; p-aminophenyl ether
202-977-0
101-80-4
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
4,4'-oxydianiline and its salts; p-aminophenyl ether
-
-
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
4,4'-thiodi-o-cresol
HMPSC
403-330-7
24197-34-0
Eye Dam. 1
4,4'-thiodianiline and its salts
-
-
Carc. 1B; Acute Tox. 4
4,4'-thiodianiline and its salts
205-370-9
139-65-1
Carc. 1B; Acute Tox. 4
4,4,5,5,5-pentafluoropentan-1-ol
421-360-9
148043-73-6
Acute Tox. 4
4,4,5,5-tetrachloro-1,3-dioxolan-2-one
CARBONATE DE TETRACHLOROETHYLENE
404-060-2
22432-68-4
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
4,4-dimethoxybutylamine
AMINOBUTYRALDEHYDE DIMETHYL ACETAL
407-690-6
19060-15-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
4,4-dimethyl-3,5,8-trioxabicyclo[5.1.0]octane
TRIOXABICYCLOOCTAN; TRIOXABICYCLOOCTANE
421-750-9
57280-22-5
Eye Irrit. 2; Skin Sens. 1
4,4-isobutylethylidenediphenol
AP-5
401-720-1
6807-17-6
Repr. 1B; Eye Irrit. 2
yes
4,5-dichloro-2-octyl-2H-isothiazol-3-one; [DCOIT]
264-843-8
64359-81-5
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1; Eye Dam. 1; Skin Sens. 1A
4,8,12-trimethyltrideca-3,7,11-trienoic acid, mixed isomers
HOMOFARNESYLSÄURE
403-000-2
91853-67-7
Skin Irrit. 2
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, ethoxylated
621-341-7
2315-61-9
yes
4-(1,1,3,3-Tetramethylbutyl)phenol, ethoxylated
-
-
yes
4-(1,1,3,3-tetramethylbutyl)phenol; 4-tert-octylphenol
205-426-2
140-66-9
Skin Irrit. 2; Eye Dam. 1
yes
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
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