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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 18 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
3-iodo-2-propynyl butylcarbamate; 3-iodoprop-2-yn-1-yl butylcarbamate
259-627-5
55406-53-6
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1
3-iodpropene; allyl iodide
209-130-4
556-56-9
Flam. Liq. 2; Skin Corr. 1B
3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate; isophorone di-isocyanate
223-861-6
4098-71-9
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
3-methylbutan-2-one; methyl isopropyl ketone
209-264-3
563-80-4
Flam. Liq. 2
3-methylheptane
209-660-6
589-81-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
3-methylhexane
209-643-3
589-34-4
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
3-methylpentane
202-481-4
96-14-0
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
3-pentanol
209-526-7
584-02-1
Flam. Liq. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
3-propanolide;1,3-propiolactone
200-340-1
57-57-8
Carc. 1B; Acute Tox. 2; Eye Irrit. 2; Skin Irrit. 2
3a,4,7,7a-tetrahydro-4,7-methanoindene
201-052-9
77-73-6
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
4,4'-(4-iminocyclohexa-2,5-dienylidenemethylene)dianiline hydrochloride; C.I. Basic Red 9
209-321-2
569-61-9
Carc. 1B
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'-carbonimidoylbis[N, N-dimethylaniline]
207-762-5
492-80-8
Carc. 2; Acute Tox. 4; Eye Irrit. 2
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'-methylenebis(2-ethylaniline); 4,4'-methylenebis(2-ethylbenzeneamine)
243-420-1
19900-65-3
Carc. 2; Acute Tox. 4
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'-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'-thiodianiline and its salts
205-370-9
139-65-1
Carc. 1B; Acute Tox. 4
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-(1,1,3,3-tetramethylbutyl)phenol; 4-tert-octylphenol
205-426-2
140-66-9
Skin Irrit. 2; Eye Dam. 1
yes
4-(1-ethyl-1-methylhexyl)phenol
257-907-1
52427-13-1
yes
4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
250-863-4
31906-04-4
Skin Sens. 1A
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-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-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-ethoxyaniline; p-phenetidine
205-855-5
156-43-4
Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
4-Heptylphenol
217-862-0
1987-50-4
yes
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-isocyanatosulphonyltoluene; tosyl isocyanate
223-810-8
4083-64-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
4-methoxy-4-methylpentan-2-one
203-512-4
107-70-0
Flam. Liq. 3; Acute Tox. 4
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-methylheptane
209-650-1
589-53-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
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