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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 23 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
phenylhydrazinium sulphate; (2:1)
257-622-2
52033-74-6
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
formaldehyde ...%
200-001-8
50-00-0
Carc. 1B; Muta. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
2,4-diaminoanisole sulphate
254-323-9
39156-41-7
Carc. 1B; Muta. 2; Acute Tox. 4
2,4-diaminoanisole; 4-methoxy-m-phenylenediamine
210-406-1
615-05-4
Carc. 1B; Muta. 2; Acute Tox. 4
N,N'-diacetylbenzidine
210-338-2
613-35-4
Carc. 1B; Muta. 2; Acute Tox. 4
safrole; 5-allyl-1,3-benzodioxole
202-345-4
94-59-7
Carc. 1B; Muta. 2; Acute Tox. 4
reaction products of paraformaldehyde and 2-hydroxypropylamine (ratio 3:2); [formaldehyde released from 3,3'-methylenebis [5-methyloxazolidine]; formaldehyde released from oxazolidin]; [MBO]
-
-
Carc. 1B; Muta. 2; Acute Tox. 4; Acute Tox. 3; STOT RE 2; Skin Corr. 1B; Eye Dam. 1; Skin Sens. 1A
quinoline
202-051-6
91-22-5
Carc. 1B; Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
azobenzene
203-102-5
103-33-3
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2
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
reaction products of paraformaldehyde with 2-hydroxypropylamine (ratio 1:1); [formaldehyde released from α,α,α-trimethyl-1,3,5-triazine-1,3,5(2H,4H,6H)-triethanol]; [HPT]
-
-
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
sodium N-(hydroxymethyl)glycinate; [formaldehyde released from sodium N-(hydroxymethyl)glycinate]
274-357-8
70161-44-3
Carc. 1B; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2; Skin Sens. 1
phenyl glycidyl ether; 2,3-epoxypropyl phenyl ether;1,2-epoxy-3-phenoxypropane
204-557-2
122-60-1
Carc. 1B; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
4,4'-bis(dimethylamino)benzophenone; Michler's ketone
202-027-5
90-94-8
Carc. 1B; Muta. 2; Eye Dam. 1
yes
oxiranemethanol, 4-methylbenzene-sulfonate, (S)-
DAISO CCS-1S-E; S-GLYTO
417-210-7
70987-78-9
Carc. 1B; Muta. 2; Eye Dam. 1; Skin Sens. 1
trichloroethylene; trichloroethene
201-167-4
79-01-6
Carc. 1B; Muta. 2; Eye Irrit. 2; Skin Irrit. 2; STOT SE 3
yes
2,3-epoxypropan-1-ol; glycidol; oxiranemethanol
209-128-3
556-52-5
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
2,3-epoxypropyl methacrylate; glycidyl methacrylate
203-441-9
106-91-2
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; STOT RE 1; Eye Dam. 1; Skin Corr. 1C; Skin Sens. 1
cobalt dichloride
231-589-4
7646-79-9
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
yes
cobalt sulfate
233-334-2
10124-43-3
Carc. 1B; Muta. 2; Repr. 1B; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
yes
cobalt
231-158-0
7440-48-4
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
cobalt carbonate
208-169-4
513-79-1
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
cobalt di(acetate)
200-755-8
71-48-7
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
cobalt dinitrate
233-402-1
10141-05-6
Carc. 1B; Muta. 2; Repr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
phenolphthalein
201-004-7
77-09-8
Carc. 1B; Muta. 2; Repr. 2
yes
cadmium oxide (non-pyrophoric)
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Monteponite (CdO) EC / List no: - | CAS no: 12139-21-8
215-146-2
1306-19-0
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1
yes
Cadmium;cadmium (non-pyrophoric);cadmium (pyrophoric)
231-152-8
7440-43-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 2; STOT RE 1
2-methyl-m-phenylenediamine; 2,6-toluenediamine;diaminotoluene, technical product - reaction mass of 4-methyl-m-phenylene diamine and 2-methyl-m-phenylene diamine; methyl-phenylenediamine
212-513-9
823-40-5
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 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
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
methyl-phenylene diamine; diaminotoluene [technical product — reaction mass of 4-methyl-m-phenylene diamine (EC No 202-453-1) and 2-methyl-m-phenylene diamine (EC No 212-513-9)]
246-910-3
25376-45-8
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 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
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Sens. 1
2,3-dinitrotoluene
210-013-5
602-01-7
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
2,4-dinitrotoluene
204-450-0
121-14-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
yes
2,5-dinitrotoluene
210-581-4
619-15-8
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
2,6-dinitrotoluene
210-106-0
606-20-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
3,4-dinitrotoluene
210-222-1
610-39-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
3,5-dinitrotoluene
210-566-2
618-85-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
dinitrotoluene
246-836-1
25321-14-6
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
2,3-epoxypropyltrimethylammonium chloride ... %; glycidyl trimethylammonium chloride ... %
221-221-0
3033-77-0
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
cadmium sulphide
215-147-8
1306-23-6
Carc. 1B; Muta. 2; Repr. 2; STOT RE 1; Acute Tox. 4
yes
reaction mass of: N-[3-hydroxy-2-(2-methylacryloylaminomethoxy)propoxymethyl]-2-methylacrylamide; N-[2,3-bis-(2-methylacryloylaminomethoxy)propoxymethyl]-2-methylacrylamide; methacrylamide; 2-methyl-N-(2-methylacryloylaminomethoxymethyl)-acrylamide; N-(2,3-dihydroxypropoxymethyl)-2-methylacrylamide
VERNETZER TMAG
412-790-8
-
Carc. 1B; Muta. 2; STOT RE 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
lead chromate
231-846-0
7758-97-6
Carc. 1B; Repr. 1A; STOT RE 2
yes
lead chromate molybdate sulfate red; C.I. Pigment Red 104 [This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77605.]
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77605.
235-759-9
12656-85-8
Carc. 1B; Repr. 1A; STOT RE 2
yes
lead sulfochromate yellow; C.I. Pigment Yellow 34 [This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77603.]
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77603.
215-693-7
1344-37-2
Carc. 1B; Repr. 1A; STOT RE 2
yes
methyl-ONN-azoxymethyl acetate; methyl azoxy methyl acetate
209-765-7
592-62-1
Carc. 1B; Repr. 1B
1,2,3-trichloropropane
202-486-1
96-18-4
Carc. 1B; Repr. 1B; Acute Tox. 4
yes
nitrofen (ISO); 2,4-dichlorophenyl 4-nitrophenyl ether
217-406-0
1836-75-5
Carc. 1B; Repr. 1B; Acute Tox. 4
reaction mass of: 1,3,5-tris(3-aminomethylphenyl)-1,3,5-(1H,3H,5H)-triazine-2,4,6 trione; reaction mass of oligomers of; 3,5-bis(3-aminomethylphenyl)1-poly[3,5-bis(3-aminomethylphenyl)-2,4,6-trioxo-1,3,5-(1H,3H,5H)-triazin-1-yl]-1,3,5(1H,3H,5H)-triazine-2,4,6-trione
BLENDUR I VP KU 3-4519
421-550-1
-
Carc. 1B; Repr. 1B; Skin Sens. 1
disodium 3,3'-[[1,1'-biphenyl]-4,4'-diylbis(azo)]bis(4-aminonaphthalene-1-sulphonate); C.I. Direct Red 28
209-358-4
573-58-0
Carc. 1B; Repr. 2
yes
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