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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 25 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
2-methylstyrene; 2-vinyltoluene
210-256-7
611-15-4
Acute Tox. 4
2-n-butyl-benzo[d]isothiazol-3-one
SUBSTANCE S123386; VANQUISH 100
420-590-7
4299-07-4
Skin Corr. 1B; Skin Sens. 1
2-n-hexadecylhydroquinone
AF-368
406-400-5
4595-26-0
STOT RE 2; Skin Irrit. 2; Skin Sens. 1
2-naphthol
205-182-7
135-19-3
Acute Tox. 4
2-naphthylamine
202-080-4
91-59-8
Carc. 1A; Acute Tox. 4
2-naphthylamino-6-sulfomethylamide
2-NAPHTHYLAMIN-6-SULFOMETHYLAMID; FAT 92'365/A
412-120-4
104295-55-8
STOT RE 2; Skin Sens. 1
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-nitro-p-anisidine; 4-methoxy-2-nitroaniline
202-547-2
96-96-8
Acute Tox. 2; Acute Tox. 1; STOT RE 2
2-nitroanisole
202-052-1
91-23-6
Carc. 1B; Acute Tox. 4
2-nitronaphthalene
209-474-5
581-89-5
Carc. 1B
2-nitropropane
201-209-1
79-46-9
Flam. Liq. 3; Carc. 1B; Acute Tox. 4
2-nitrotoluene
201-853-3
88-72-2
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 4
2-phenoxyethanol
204-589-7
122-99-6
Acute Tox. 4; Eye Irrit. 2
2-phenyl-1,3-propanediol
1,3-PPD
411-810-2
1570-95-2
Eye Dam. 1
2-phenylethylisocyanate
2-PHENYLETHYLISOCYANAT; 2-PHENYLETHYLISOCYANATE; PHENYL ETHYL ISOCYANATE
413-080-0
1943-82-4
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
2-phenylhexanenitrile
SALICYNALVA
423-460-8
3508-98-3
Acute Tox. 4
2-phenylphenol (ISO)biphenyl-2-ol; 2-hydroxybiphenyl
201-993-5
90-43-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
2-phenylpropene; α-methylstyrene
202-705-0
98-83-9
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
2-phenylthioaniline
2-ADPS
413-030-8
1134-94-7
Skin Sens. 1
2-phthalimidoethyl N-[4-(2-cyano-4-nitrophenylazo)phenyl]-N-methyl-β-alaninate
426-400-9
170222-39-6
Skin Sens. 1
2-piperazin-1-ylethylamine
205-411-0
140-31-8
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
2-tert-butylaminoethyl methacrylate
223-228-4
3775-90-4
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
2-thiazolidinylidenecyanamide
427-720-1
26364-65-8
Acute Tox. 4; STOT RE 2
2-{4-(2-ammoniopropylamino)-6-[4-hydroxy-3-(5-methyl-2-methoxy-4-sulfamoylphenylazo)-2-sulfonatonaphth-7-ylamino]-1,3,5-triazin-2-ylamino}-2-aminopropyl formate
SCARLET PE 3948
424-260-3
784157-49-9
Repr. 2; Eye Dam. 1
2-{4-[4-[4-fluoro-6-(2-(2-vinylsulfonylethoxy)ethylamino)-1,3,5-triazin-2-ylamino]phenylazophenylazo}naphthalene-4,6,8-trisulfonate, trisodium salt
442-230-8
321679-52-1
Eye Dam. 1
2S-isopropyl-5R-methyl-1R-cyclohexyl 2,2-dihydroxyacetate
GLYOXYLATE DE MENTHYLE HYDRATÉ; MENTHYL GLYOXYLATE HYDRATE
416-810-6
111969-64-3
STOT RE 2; Eye Dam. 1
3',5'-dichloro-4'-ethyl-2'-hydroxypalmitanilide
COUPLER II; UC-136
406-200-8
117827-06-2
Skin Sens. 1
3'-(3-acetyl-4-hydroxyphenyl)-1,1-diethylurea
A1354
411-970-3
79881-89-3
Acute Tox. 4; STOT RE 2
3'-trifluoromethylisobutyranilide
BTA-A; FLUTAMIDE BTA-A
406-740-4
1939-27-1
STOT RE 2
3(or 5)-(4-(N-benzyl-N-ethylamino)-2-methylphenylazo)1,4-dimethyl-1,2,4-triazolium methylsulphate
BASIC RED FC 48215
406-055-0
124584-00-5
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
3,10-diamino-6,13-dichloro-2-((6-(((4-(1,1-dimethylethyl)phenyl)sulfonyl)amino)-2-naphthalenyl)sulfonyl)-4,11-triphenodioxazinedisulfonic acid, lithium potassium sodium salt
440-770-9
371921-63-0
Eye Dam. 1
3,3'-dichlorobenzidine; 3,3'-dichlorobiphenyl-4,4'-ylenediamine
202-109-0
91-94-1
Carc. 1B; Acute Tox. 4; Skin Sens. 1
3,3'-dimethoxybenzidine; o-dianisidine
204-355-4
119-90-4
Carc. 1B; Acute Tox. 4
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
3,3,4,4-tetrafluoro-4-iodo-1-butene
439-500-2
33831-83-3
Acute Tox. 4; Skin Irrit. 2
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
3,4,3', 4'-tetraphenyl-1,1'-ethandiylbispyrol-2,5-dione
431-500-0
226065-73-2
Skin Sens. 1
3,4,5,6-tetrahydrophthalic anhydride
219-374-3
2426-02-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
3,4-dichloroaniline
202-448-4
95-76-1
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
3,4-dihydroxy-5-nitrobenzaldehyde
441-810-8
116313-85-0
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
3,4-dimethyl-1H-pyrazole
429-130-1
2820-37-3
Acute Tox. 4; Eye Dam. 1
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
3,4-dinitrotoluene
210-222-1
610-39-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
3,4-xylenol
202-439-5
95-65-8
Acute Tox. 3; Skin Corr. 1B
3,5,5-trimethylcyclohex-2-enone; isophorone
201-126-0
78-59-1
Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
3,5-bis-(tetradecyloxycarbonyl)benzenesulfinic acid
AF-389
407-990-7
141915-64-2
Skin Sens. 1
3,5-dichloro-2,4-difluorobenzoyl fluoride
3,5-DICHLORO-2,4-DIFLUOROBENZOYLFLUORIDE
401-800-6
101513-70-6
Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
3,5-dichloro-2,6-difluoropyrdine-4-amine
220-630-1
2840-00-8
Acute Tox. 4
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