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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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.

Last updated 18 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
pentasodium monohydrogen 6-chloro-3,10-bis[2-[4-chloro-6-(2,4-disulfophenylamino)-1,3,5-triazin-2-yl-amino]ethylamino]-13-ethylbenzo[5.6][1.4]oxazino[2,3-b]phenoxazine-4,11-disulfonate	414-910-4	-	Eye Dam. 1; Skin Sens. 1
Peptostreptococcus anaerobius	-	-		B Bacteria and similar species
Plasmodium falciparum	-	-		P Parasites
Plasmodium spp. (human and simian)	-	-		P Parasites
Plesiomonas shigelloides	-	-		B Bacteria and similar species
Polioviruses	-	-		V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
poly-(methyl methacrylate)-co-(butylmethacrylate)-co-(4-acryloxybutyl-isopropenyl-α, α-dimethylbenzyl carbamate)-co-(maleicanhydride) RX-33	419-590-1	-	Flam. Sol. 1; Skin Sens. 1
Porphyromonas spp.	-	-		B Bacteria and similar species
potassium 3-iodo-6-methylbenzenesulfonate	426-300-5	-	Eye Dam. 1
potassium sodium 4-(4-chloro-6-(3,6-disulfonato-7-(5,8-disulfonato-naphthalen-2-ylazo)-8-hydroxy-naphthalen-1-ylamino)-1,3,5-triazin-2-ylamino)-5-hydroxy-6-(4-(2-sulfatoethanesulfonyl)-phenylazo)-naphthalene-1,7-disulfonate REAKTIVROT 2713	412-490-7	-	Skin Sens. 1
potassium sodium 5-(4-chloro-6-(N-(4-(4-chloro-6-(5-hydroxy-2,7-disulphonato-6-(2-sulphonatophenylazo)-4-naphthylamino)-1,3,5-triazin-2-ylamino) phenyl-N-methyl)amino)-1,3,5-triazin-2-ylamino)-4-hydroxy-3-(2-sulphonatophenylazo)naphthalene-2,7-disulphonat C.I. REACTIVE RED 231	402-150-6	-	Eye Irrit. 2; Skin Sens. 1
potassium tetrasodium bis[(N,N'-n)-1'-(phenylcarbamoyl)-3,5-disulfonatobenzeneazo-1'-prop-1'-ene-2,2'-diolato]chromate(III)	425-830-4	-	Eye Dam. 1
Powassan	-	-		V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
Prevotella spp.	-	-		B Bacteria and similar species
product by process iron complex of azo dyestuffs obtained by coupling a mixture of diazotized 2-amino-1-hydroxybenzene-4-sulfanilide and 2-amino-1-hydroxybenzene-4-sulfonamide with resorcin, the obtained mixture being subsequently submitted to a second coupling reaction with a mixture of diazotized 3-aminobenzene-1-sulfonic acid (metanilic acid) and 4'-amino-4-nitro-1,1'-diphenylamine-2-sulfonic acid and metallization with ferric chloride, sodium salt BROWN JR 547	419-260-5	-	Eye Dam. 1
product-by-process definition polyazodyestuff obtained by coupling 4-[4-(1-amino-8-hydroxy-3,6-disulfo-2-naphthylazo)phenylsulfonylamino] benzenediazonium with reaction mass of 4-carboxybenzenediazonium and diphenylamine-3-sulfo-4,4'-bisdiazonium, and further coupling of the obtained compounds with reaction mass of naphth-2-ol and 3-aminophenol, sodium salts; sodium chloride	425-740-5	-	Eye Dam. 1
Prospect Hill virus	-	-		V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
Proteus mirabilis	-	-		B Bacteria and similar species
Proteus penneri	-	-		B Bacteria and similar species
Proteus vulgaris	-	-		B Bacteria and similar species
Providencia alcalifaciens	-	-		B Bacteria and similar species
Providencia rettgeri	-	-		B Bacteria and similar species
Providencia spp.	-	-		B Bacteria and similar species
Puumala virus	-	-		V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
pyrethrins including cinerins, with the exception of those specified elsewhere in this Annex	-	-	Acute Tox. 4
Rabbitpox virus	-	-		V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
Rabies virus	-	-		V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
reaction mass of 1,1'-((dihydroxyphenylene)bis(azo-3,1-phenylenazo(1-(3-dimethylaminopropyl)-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl)))dipyridinium dichloride dihydrochloride, mixed isomers and 1-(1-(3-dimethylaminopropyl)-5-(3-((4-(1-(3-dimethylaminopropyl)-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-5-pyridinio-3-pyridylazo)phenylazo)-2,4(or 2,6 or 3,5)-dihydroxyphenylazo)phenylazo)-1,2-dihydro-6-hydroxy-4-methyl-2-oxo-3-pyridyl)pyridinium dichloride BRAUN HM 2763; BROWN HM 2763; BRUN HM 2763; BRUNO HM 2763	404-540-1	-	Skin Sens. 1
reaction mass of 1,1'-(methylenebis(4,1-phenylene))dipyrrole-2,5-dione and N-(4-(4-(2,5-dioxopyrrol-1-yl)benzyl)phenyl)acetamide and 1-(4-(4-(5- oxo-2H-2-furylide namino)benzyl)phenyl)pyrrole-2,5-dione DESBIMID	401-970-1	-	Skin Sens. 1
reaction mass of 2-acryloyloxyethyl hydrogen cyclohexane-1,2-dicarboxylate and 2-methacryloyloxyethyl hydrogen cyclohexane-1,2-dicarboxylate KAYARAD R-825	405-360-6	-	Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
reaction mass of 2-chloroethyl chloropropyl 2-chloroethylphosphonate, reaction mass of isomers and 2-chloroethyl chloropropyl 2-chloropropylphosphonate, reaction mass of isomers ADINE CP 31	401-740-0	-	Acute Tox. 4
Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate; reaction mass of DOTE and MOTE	915-270-3	-			yes
reaction mass of 5-heptyl-1,2,4- triazol-3-ylamine and 5-nonyl-1,2,4-triazol-3-ylamine PK 323	401-940-8	-	Acute Tox. 4; Eye Irrit. 2
reaction mass of C12-14-tert-alkylammonium diphenyl phosphorothioate and dinonyl sulphide (or disulphide) X 3761	400-930-0	-	Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
reaction mass of iron complexes of: 1,3-dihydroxy-4-[(5-phenylaminosulfonyl)-2-hydroxyphenylazo]-n-(5-amino-sulfonyl-2-hydroxyphenylazo)benzene; and: 1,3-dihydroxy-4-[(5-phenylaminosulfonyl)-2-hydroxyphenylazo]-n-[4-(4-nitro-2-sulfophenylamino)phenylazo]benzene (n=2,5,6) BROWN JR 543	414-150-3	-	Skin Sens. 1
reaction mass of isomers of: sodium [(2-hydroxyethylsulfamoyl){][}2-(2-piperazin-1-ylethylamino)ethylsulfamoyl][2-(4-aminoethylpiperazine-1-yl)ethylsulfamoyl{](sulfamoyl)[}(sulfonatophthalocyaninato)]copper(II) SUBSTANCE S166075	424-270-8	-	Eye Dam. 1
reaction mass of isomers of: sodium phenethylnaphthalenesulfonate; sodium naphthylethylbenzenesulfonate UNISOL S	405-760-0	-	Eye Dam. 1; Skin Sens. 1
reaction mass of isomers of: α-((dimethyl)biphenyl)-ω-hydroxypoly(oxyethylene) EMULGATOR SWA; EMULVIN SWA	406-325-8	-	Acute Tox. 4
reaction mass of mono to tetra(lithium and/or sodium)3-amino-10-[4-(4-amino-3-sulfonatoanilino)-6-[methyl-(2-sulfonatoethyl)amino]-1,3,5-triazin-2-ylamino]-6-13-dichlorobenzo[1,2-B:4,5-B']di[1,4]benzoxazine-4,11-disulfonate; mono to tetra(lithium and/or sodium)3-amino-10-[4,6-bis(4-amino-3-sulfonatoanilino)-1,3,5-triazin-2-ylamino]-6-13-dichlorobenzo[1,2-B:4,5-B']di[1,4]benzoxazine-4,11-disulfonate; mono to penta(lithium and/or sodium)10,10'-diamino-6,6',13,13'-tetrachloro-3,3'-[6-[methyl-(2-sulfonatoethyl)amino]-1,3,5-triazin-2,4-diyldiimino]bis[benzo[1,2-B:4,5-B']di[1,4]benzoxazine-4,11-disulfonate; mono to hepta(lithium and/or sodium)10-amino-6,6', 13,13'-tetrachloro-10'[4-(4-amino-3-sulfonatoanilino)-[6-methyl-(2-sulfonatoethyl)amino]-1,3,5-triazin-2,4-diimino]bis[benzo[1,2-B:4,5-B']di[1,4]benzoxazine-4,11-disulfonate; mono to hepta(lithium and/or sodium)10,10'-diamino-6,6',3,3'[(2-sulfonato)-1,4-phenylenediiminobis[6-methyl-(2-sulfonatoethyl)amino]-1,3,5-triazin-2,4-diyldiimino]bis[benzo[1,2-B:4,5-B']di[1,4]benzoxazine-4,11-disulfonate	430-200-7	-	Eye Dam. 1
reaction mass of n-octadecylaminodiethyl bis(hydrogen maleate); n-octadecylaminodiethyl hydrogen maleate hydrogenphthalate ETHOXYLATED POLYESTER RESIN	405-960-8	-	Skin Sens. 1
reaction mass of trisodium 3-(5-(2,6-difluoropyrimidin-4-ylamino)-2-sulfonatophenylazo)5-(4-fluoro-6-morpholin-4-yl-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-naphthalenedisulfonate; trisodium 3-(5-(4,6-difluoropyrimidin-2-ylamino)-2-sulfonatophenylazo)-5-(4-fluoro-6-morpholin-4-yl-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-naphthalenedisulfonate	436-890-6	-	Eye Dam. 1
reaction mass of α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-hydroxypoly(oxyethylene) and α-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyl-ω-3-(3-(2H-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl)propionyloxypoly(oxyethylene) EVERSORB 80; TINUVIN 1130; TINUVIN 213	400-830-7	-	Skin Sens. 1
reaction mass of: ((Z)-3,7-dimethyl-2,6-octadienyl)oxycarbonylpropanoic acid; di-((E)-3,7-dimethyl-2,6-octadienyl) butandioate; di-((Z)-3,7-dimethyl-2,6-octadienyl) butandioate; (Z)-3,7-dimethyl-2,6-octadienyl butandioate; ((E)-3,7-dimethyl-2,6-octadienyl)oxycarbonylpropanoic acid MS6119	415-190-4	-	Skin Sens. 1
reaction mass of: (3-methoxy)propylammonium/[tris-(2-hydroxyethyl)]ammonium 2-(2-(bis(2-hydroxyethyl)amino)ethoxycarbonylmethyl)hexadec-4-enoate; (3-methoxy)propylammonium/ [tris-(2-hydroxyethyl)]ammonium 2-(2-(bis(2-hydroxyethyl)amino)ethoxycarbonylmethyl)tetradec-4-enoate; (3-methoxy)propylammonium/[tris-(2-hydroxyethyl)]ammonium 2-(3-methoxypropylcarbamoylmethyl)hexadec-4-enoate; (3-methoxy)propylammonium/ [tris-(2-hydroxyethyl)]ammonium 2-(3-methoxypropylcarbamoylmethyl)tetradec-4-enoate HOSTACOR 4205 CONC.; HOSTACOR V 4205	413-500-2	-	Skin Irrit. 2; Eye Dam. 1
reaction mass of: (3R)-[1S-(1α,2α, 6β-((2S)-2-methyl-1-oxo-butoxy)-8aγ)hexahydro-2,6-dimethyl-1-naphthalene]-3,5-dihydroxyheptanoic acid; inert biomass from Aspergillus terreus LOVASTATIN FREE ACID	415-840-7	-	Skin Sens. 1
reaction mass of: 1,2-dimethylpropylidene dihydroperoxide; dimethyl 1,2-benzenedicarboxylate	442-480-8	-	Org. Perox. C; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
reaction mass of: 1,2-naphthoquinonediazide-5-sulfonylchloride (or sulfonic acid)monoester with 4,4'-(1-(4-(1-(4-hydroxyphenyl)-1-methylethyl)phenyl)ethylidene)bisphenol; 1,2-naphthoquinonediazide-5-sulfonylchloride(or sulfonicacid)diester with 4,4'-(1-(4-(1-(4-hydroxyphenyl)-1-methylethyl)phenyl)ethylidene)bisphenol; 1,2-naphthoquinonediazide-5-sulfonylchloride (or sulfonic acid)triester with 4,4'-(1-(4-(1-(4-hydroxyphenyl)-1-methylethyl)phenyl)ethylidene)bisphenol	433-640-8	-	Pyr. Sol. 1
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
reaction mass of: 1,7-dimethyl-2-[(3-methylbicyclo[2.2.1]hept-2-yl)methyl]bicyclo[2.2.1]heptane; 2,3-dimethyl-2-[(3-methylbicyclo[2.2.1]hept-2-yl)methyl]bicyclo[2.2.1]heptane	427-040-5	-	Skin Corr. 1B
Reaction mass of: 1-(1'H,1'H,2'H,2'H-tridecafluorooctyl)-12-(1''H,1''H,2''H,2''H-tridecafluorooctyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-tridecafluorooctyl)-12-(1''H,1''H,2''H,2''H-heptdecafluorodecyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-tridecafluorooctyl)-12-(1''H,1''H,2''H,2''H-heneicosafluorododecyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-tridecafluorooctyl)-12-(1''H,1''H,2''H,2''H-pentacosafluorotetradecyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-heptadecafluorodecyl)-12-(1''H,1''H,2''H,2''H-heptadecafluorodecyl)dodecanedioate; 1-(1'H,1'H,2'H,2'H-heptadecafluorodecyl)-12-(1''H,1''H,2''H,2''H-heneicosafluorododecyl)dodecanedioate HFR-990	423-180-6	-	STOT RE 2

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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

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Last updated 18 april 2024. Database contains 4753 unique substances/entries.

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