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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
molybdenum nickel tetraoxide
238-034-5
14177-55-0
Carc. 1A; STOT RE 1; Skin Sens. 1
molybdenum trioxide
215-204-7
1313-27-5
Carc. 2; Eye Irrit. 2; STOT SE 3
mono-methylamine;mono-methylamine ... %
200-820-0
74-89-5
Flam. Gas 1; Press. Gas; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
mono-methylamine;mono-methylamine ... %
200-820-0
74-89-5
Flam. Liq. 1; Acute Tox. 4; Skin Corr. 1B
monobenzone; 4-hydroxyphenyl benzyl ether; hydroquinone monobenzyl ether
203-083-3
103-16-2
Eye Irrit. 2; Skin Sens. 1
monocrotophos (ISO); dimethyl-1-methyl-2-(methylcarbamoyl)vinyl phosphate
230-042-7
6923-22-4
Muta. 2; Acute Tox. 2; Acute Tox. 3
monolinuron (ISO); 3-(4-chlorophenyl)-1-methoxy-1-methylurea
217-129-5
1746-81-2
Acute Tox. 4; STOT RE 2
monuron (ISO); 3-(4-chlorophenyl)-1,1-dimethylurea
205-766-1
150-68-5
Carc. 2; Acute Tox. 4
morfamquat dichloride
225-062-8
4636-83-3
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
morpholine
203-815-1
110-91-8
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
morpholine-4-carbonyl chloride
239-213-0
15159-40-7
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
morphothion (ISO); O, O-dimethyl-S-(morpholinocarbonylmethyl) phosphorodithioate
205-628-0
144-41-2
Acute Tox. 3
muscalure; cis-tricos-9-ene
248-505-7
27519-02-4
Skin Sens. 1B
musk ketone; 3,5-dinitro-2,6-dimethyl-4-tert-butylacetophenone; 4'-tert-butyl-2', 6'-dimethyl-3',; 5'-dinitroacetophenone
201-328-9
81-14-1
Carc. 2
musk xylene; 5-tert-butyl-2,4,6-trinitro-m-xylene
201-329-4
81-15-2
Expl. 1.1; Carc. 2
yes
N, N'-diphenyl-p-phenylenediamine; N, N'-diphenyl-1,4-benzenediamine
200-806-4
74-31-7
Skin Sens. 1
N, N,N',N'-tetramethyl-p-phenylenediamine
202-831-6
100-22-1
Acute Tox. 4
N, N,N',N'-tetramethylethylenediamine
203-744-6
110-18-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B
N, N-bis(3-aminopropyl)methylamine
203-336-8
105-83-9
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
N, N-dimethylformamide; dimethyl formamide
200-679-5
68-12-2
Repr. 1B; Acute Tox. 4; Eye Irrit. 2
yes
N,N'-diacetylbenzidine
210-338-2
613-35-4
Carc. 1B; Muta. 2; Acute Tox. 4
N,N'-methylenedimorpholine; N,N'-methylenebismorpholine [formaldehyde released from N,N'-methylenebismorpholine]; [MBM]
227-062-3
5625-90-1
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1; Eye Dam. 1
N,N,N',N'-tetramethyl-4,4'-methylendianiline
202-959-2
101-61-1
Carc. 1B
yes
N,N,N-trimethylanilinium chloride
205-319-0
138-24-9
Acute Tox. 3
N,N-diethyl-m-toluamide; deet
205-149-7
134-62-3
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
N,N-diethylaniline
202-088-8
91-66-7
Acute Tox. 3; STOT RE 2
N,N-dimethyl-m-toluidine
204-495-6
121-72-2
Acute Tox. 3; STOT RE 2
N,N-dimethyl-o-toluidine
210-199-8
609-72-3
Acute Tox. 3; STOT RE 2
N,N-dimethyl-p-toluidine
202-805-4
99-97-8
Acute Tox. 3; STOT RE 2
N,N-dimethylacetamide
204-826-4
127-19-5
Repr. 1B; Acute Tox. 4
yes
N,N-dimethylaniline
204-493-5
121-69-7
Carc. 2; Acute Tox. 3
N,N-dimethylbenzene-1,3-diamine
220-623-3
2836-04-6
Acute Tox. 3
N,N-dimethylhydrazine
200-316-0
57-14-7
Flam. Liq. 2; Carc. 1B; Acute Tox. 3; Skin Corr. 1B
N-(2-(4-amino-N-ethyl-m-toluidino)ethyl)methanesulphonamide sesquisulphate; 4-(N-ethyl-N-2-methanesulphonylaminoethyl)-2-methylphenylenediamine sesquisulphate monohydrate
247-161-5
25646-71-3
Acute Tox. 4; Skin Sens. 1
N-(dichlorofluoromethylthio)phthalimide; N-(fluorodichloromethylthio)phthalimide
211-952-3
719-96-0
Skin Irrit. 2
N-(hydroxymethyl)acrylamide; methylolacrylamide; [NMA]
213-103-2
924-42-5
Carc. 1B; Muta. 1B; STOT RE 1
N-2-naphthylaniline; N-phenyl-2-naphthylamine
205-223-9
135-88-6
Carc. 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
n-butyl acetate
204-658-1
123-86-4
Flam. Liq. 3; STOT SE 3
n-butyl acrylate
205-480-7
141-32-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
n-butyl methacrylate
202-615-1
97-88-1
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
n-butyl propionate
209-669-5
590-01-2
Flam. Liq. 3
n-butyronitrile
203-700-6
109-74-0
Flam. Liq. 2; Acute Tox. 3
N-carboxymethyliminobis(ethylenenitrilo)tetra (acetic acid)
200-652-8
67-43-6
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
N-cyclohexylbenzothiazole-2- sulphenamide
202-411-2
95-33-0
Skin Sens. 1
N-ethyl-2-pyrrolidone; 1-ethylpyrrolidin-2-one
220-250-6
2687-91-4
Repr. 1B
N-ethylaniline
203-135-5
103-69-5
Acute Tox. 3; STOT RE 2
n-hexane
203-777-6
110-54-3
Flam. Liq. 2; Repr. 2; Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; STOT SE 3
N-isopropyl-N'-phenyl-p-phenylenediamine
202-969-7
101-72-4
Acute Tox. 4; Skin Sens. 1
N-methyl-2-pyrrolidone; 1-methyl-2-pyrrolidone
212-828-1
872-50-4
Repr. 1B; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2
yes
N-methyl-m-toluidine
211-795-0
696-44-6
Acute Tox. 3; STOT RE 2
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