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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 15 maj 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
2,3,4-trimethylpentane
209-292-6
565-75-3
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,3,6-TBA (ISO); 2,3,6-trichlorobenzoic acid
200-026-4
50-31-7
Acute Tox. 4
2,3-dimethylhexane
209-547-1
584-94-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,3-dimethylpentane
209-280-0
565-59-3
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
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-xylenol
208-395-3
526-75-0
Acute Tox. 3; Skin Corr. 1B
2,4-diamino-5-methoxymethylpyrimidine
DAMP
410-330-0
54236-98-5
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
2,4-diethyl-1,5-pentanediol
429-310-8
57987-55-0
Eye Dam. 1
2,4-dimethylhexane
209-649-6
589-43-5
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,4-dimethylpentan-3-one; di-isopropyl ketone
209-294-7
565-80-0
Flam. Liq. 2; Acute Tox. 4
2,4-dinitrophenol
200-087-7
51-28-5
Acute Tox. 3; Acute Tox. 2; STOT RE 1
2,5-dimethylhexane
209-745-8
592-13-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,6-diethylaniline
209-445-7
579-66-8
Acute Tox. 4
2,6-dinitrophenol
209-357-9
573-56-8
Acute Tox. 3; STOT RE 2
2,6-xylenol
209-400-1
576-26-1
Acute Tox. 3; Skin Corr. 1B
2-(1-methylpropyl)-4-tert-butylphenol
2S4TBP
421-740-4
51390-14-8
Skin Corr. 1B
2-(3-bromophenoxy)tetrahydro-2H-pyran
CP-328,914
429-030-6
57999-49-2
Skin Sens. 1
2-(4-tert-butylphenyl)ethanol
TBPE
410-020-5
5406-86-0
Repr. 2; STOT RE 2; Eye Dam. 1
2-(diphosphonomethyl)succinic acid
KEINE
403-070-4
51395-42-7
Skin Corr. 1B; Skin Sens. 1
2-(N-benzyl-N-methylamino)ethyl 3-amino-2-butenoate
EM
405-350-1
54527-73-0
Skin Sens. 1
2-[(4-chloro-2-nitrophenyl)amino]ethanol
CHLORGELB; HC YELLOW 12
413-280-8
59320-13-7
Acute Tox. 4
2-amino-4-chloro-6-methoxypyrimidine
DPX N6186; N 6186
410-050-9
5734-64-5
Acute Tox. 4
2-chloro-4-(methylsulfonyl)benzoic acid
2-CHLOR-4-METHYLSULFONYLBENZOESÄURE; CMSBA
406-520-8
53250-83-2
Eye Dam. 1
2-chloropropionic acid
209-952-3
598-78-7
Acute Tox. 4; Skin Corr. 1A
2-cyclopentene-1-acetic acid, 3-hydroxy-2-pentyl-, methyl ester acetate
431-400-7
57374-49-9
Skin Sens. 1
2-ethoxy-1-methylethyl acetate; 2PG1EEA
259-370-9
54839-24-6
Flam. Liq. 3; STOT SE 3
2-ethylhexyl 10-ethyl-4,4-dimethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate
260-829-0
57583-35-4
Repr. 2; Acute Tox. 4; STOT RE 1; Skin Sens. 1A
2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate
260-828-5
57583-34-3
Repr. 2
2-methylcyclohexanol, mixed isomers
209-512-0
583-59-5
Acute Tox. 4
2-methylcyclohexanone
209-513-6
583-60-8
Flam. Liq. 3; Acute Tox. 4
2-methylheptane
209-747-9
592-27-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2-methylhexane
209-730-6
591-76-4
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2-nitro-2-phenyl-1,3-propanediol
2-NPP
410-360-4
5428-02-4
STOT RE 1; Acute Tox. 4; Skin Sens. 1
2-nitronaphthalene
209-474-5
581-89-5
Carc. 1B
3,3'-iminodi(propylamine); dipropylenetriamine
200-261-2
56-18-8
Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
3,3-dimethylhexane
209-243-9
563-16-6
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
3,3-dimethylpentane
209-230-8
562-49-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
3,4-dimethylhexane
209-504-7
583-48-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
3,4-dinitrophenol
209-415-3
577-71-9
Acute Tox. 3; STOT RE 2
3,7-dimethylocta-2,6-dienenitrile
225-918-0
5146-66-7
Muta. 1B
3-(3-biphenyl-4-yl-1,2,3,4-tetrahydro-1-naphthyl)-4-hydroxycoumarin; difenacoum
259-978-4
56073-07-5
Repr. 1B; Acute Tox. 1; STOT RE 1
3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
257-187-9
51414-25-6
Skin Sens. 1A
3-acetyl-6-methyl-2H-pyran-2,4(3H)-dione; dehydracetic acid
208-293-9
520-45-6
Acute Tox. 4
3-aminophenol
209-711-2
591-27-5
Acute Tox. 4
3-butoxypropan-2-ol; propylene glycol monobutyl ether
225-878-4
5131-66-8
Eye Irrit. 2; Skin Irrit. 2
3-chloro-2-methylpropene
209-251-2
563-47-3
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
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-methyl-5-phenylpentan-1-al
433-900-0
55066-49-4
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
3-methylbutan-2-one; methyl isopropyl ketone
209-264-3
563-80-4
Flam. Liq. 2
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