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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 19 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
3,3,4,4-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
3,5-dichloro-2-fluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)aniline
HPDCFA
441-190-9
121451-05-6
Acute Tox. 4; Skin Sens. 1
3,5-dichloro-4-(1,1,2,2-tetrafluoroethoxy)aniline
DCATFOB; XRD 473 ANILINE
401-790-3
104147-32-2
Acute Tox. 4
3,5-dimethylbenzoyl chloride
DMBC
413-010-9
6613-44-1
Skin Corr. 1B; Skin Sens. 1
3,5-dinitrotoluene
210-566-2
618-85-9
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
3,5-xylenol; 3,5-dimethylphenol
203-606-5
108-68-9
Acute Tox. 3; Skin Corr. 1B
3,6,9,12-tetra-azatetradecamethylenediamine; pentacthylenehexamine
223-775-9
4067-16-7
Skin Corr. 1B; Skin Sens. 1
3,6,9-triazaundecamethylenediamine; tetraethylenepentamine
203-986-2
112-57-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
3,6-diazaoctanethylenediamin; triethylenetetramine
203-950-6
112-24-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
3,6-dichloro-o-anisic acid, compound with dimethylamine (1:1)
218-951-7
2300-66-5
Eye Irrit. 2
3,7-dimethylocta-2,6-dienenitrile
225-918-0
5146-66-7
Muta. 1B
3,7-dimethyloctanenitrile
HYPO-LEM
403-620-3
40188-41-8
Skin Irrit. 2; Skin Sens. 1
3,9-bis(2-(3-(3-tert-butyl-4-hydroxy-5-methylphenyl)propionyloxy-1,1-dimethylethyl)-2,4,8,10-tetraoxaspiro[5.5]undecane
ADK STAB AO 80; SUMILIZER GA-80
410-730-5
90498-90-1
Acute Tox. 4
3-((2-nitro-4-(trifluoromethyl)phenyl)amino)propane-1,2-diol
FLUORGELB
410-010-0
104333-00-8
Acute Tox. 4
3-((4-(bis(2-hydroxyethyl)amino)-2-nitrophenyl)amino)-1-propanol
IMEXINE FAG
410-910-3
104226-19-9
Skin Sens. 1
3-((C12-18)-acylamino)-N-(2-((2-hydroxyethyl)amino)-2-oxoethyl)-N,N-dimethyl-1-propanaminium chloride
427-370-1
164288-56-6
Eye Dam. 1
3-(2'-phenoxyethoxy)propylamine
427-870-8
6903-18-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
3-(2,4-bis(4-((5-(4,6-bis(2-aminopropylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-disulfonaphthalen-3-yl)azo)phenylamino)-1,3,5-triazin-6-ylamino)propyldiethylammonium lactate
BLUE PE 3811
424-310-4
178452-66-9
Eye Dam. 1
3-(2-(diaminomethyleneamino)thiazol-4-ylmethylthio)propionitrile
TPN
403-710-2
76823-93-3
Acute Tox. 4; Skin Sens. 1
3-(2-bromopropionoyl)-4,4-dimethyl-1,3-oxazolan-2-one
430-820-8
114341-88-7
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
3-(2-chloroethyl)-6,7,8,9-tetra-hydro-2-methyl-4H-pyrido[1,2-a] pyrimidin-4-one monohydrochloride
424-530-0
93076-03-0
Acute Tox. 3; STOT SE 2; STOT RE 2; Eye Dam. 1; Skin Sens. 1
3-(2-ethylhexyloxy)propane-1,2-diol
2-EHOPD; EHOPD; GE-EH; SENSIVA SC 50
408-080-2
70445-33-9
Eye Dam. 1
3-(2H-tetrazol-5-yl)pyridine
5-(3-PYRIDYL)-TETRAZOL
426-810-8
3250-74-6
Eye Dam. 1
3-(3-amino-5-(1-methylguanidino)-1-oxopentylamino-6-(4-amino-2-oxo-2,3-dihydro-pyrimidin-1-yl)-2,3-dihydro-(6H)-pyran-2-carboxylic acid; blasticidin-s
606-640-2
2079-00-7
Acute Tox. 2
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-(3-methylpent-3-yl)isoxazol-5- ylamine
128719
401-460-9
82560-06-3
Acute Tox. 3; Eye Dam. 1
3-(3-tert-butyl-4-hydroxyphenyl)propionic acid
G 19-675 ZP
403-920-4
107551-67-7
Acute Tox. 4; Eye Irrit. 2
3-(4-aminophenyl)-2-cyano-2-propenoic acid
AMPCPA
417-480-6
252977-62-1
Skin Sens. 1
3-(4-chlorophenyl)-1,1-dimethyluronium trichloroacetate; monuron-TCA
620-358-7
140-41-0
Carc. 2; Eye Irrit. 2; Skin Irrit. 2
3-(4-fluorophenyl)-2-methylpropionylchloride
426-370-7
1017183-70-8
Skin Corr. 1A; Acute Tox. 4
3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
257-187-9
51414-25-6
Skin Sens. 1A
3-(6-O-(6-desoxy-α-l-mannopyranosyl-O-(α-d-glucopyranosyl)-(β-d-glucopyranosyl)oxy)-2-(3,4-dihydroxyphenyl)-5,7-dihydroxy-4H-1-benzopyran-4-one
424-170-4
130603-71-3
Skin Sens. 1
3-(benzo[b]thien-2-yl)-5,6-dihydro-1,4,2-oxathiazine-4-oxide
431-030-6
163269-30-5
Acute Tox. 3; STOT RE 2; Eye Dam. 1
3-(bis(2-ethylhexyl)amino methyl)benzothiazole-2(3H)- thione
CM 22-447
402-540-6
105254-85-1
Skin Corr. 1B; Skin Sens. 1
3-(cis-1-propenyl)-7-amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid
7-PACA
415-750-8
106447-44-3
Skin Sens. 1
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