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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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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Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU_BA Directive 2000/54/EC
EU REACH: List of SVHC
quinclorac (ISO); 3,7-dichloroquinoline-8-carboxylic acid
BAS 514 H
402-780-1
84087-01-4
Skin Sens. 1
quinolin-8-ol; 8-hydroxyquinoline
205-711-1
148-24-3
Repr. 1B; Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
quinoline
202-051-6
91-22-5
Carc. 1B; Muta. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
quinomethionate; chinomethionat (ISO); 6-methyl-1,3-dithiolo(4,5-b)quinoxalin-2-one
219-455-3
2439-01-2
Repr. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
quinoxyfen (ISO);5,7-dichloro-4-(4-fluorophenoxy)quinoline
602-997-3
124495-18-7
Skin Sens. 1
quintozene (ISO); pentachloronitrobenzene
201-435-0
82-68-8
Skin Sens. 1
quizalofop-P-tefuryl (ISO); (±) tetrahydrofurfuryl (R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenyloxy]propionate
PANTERA; QUIZALOFOP-P-TEFURYL
414-200-4
119738-06-6
Carc. 2; Repr. 2; Acute Tox. 4; STOT RE 2
R, R-2-hydroxy-5-(1-hydroxy-2-(4-phenylbut-2-ylamino)ethyl)benzamide hydrogen 2,3-bis(benzoyloxy)succinate
SCH.19927 DIBENZOYLTARTRATE
404-390-7
88976-55-0
Flam. Sol. 1; Skin Sens. 1
R-1-chloro-2,3-epoxypropane
(R)-EPICHLOROHYDRIN
424-280-2
51594-55-9
Flam. Liq. 3; Carc. 1B; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
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.
Raffinates (petroleum), catalytic reformer ethylene glycol-water countercurrent exts.; Low boiling point modified naphtha [ complex combination of hydrocarbons obtained as the raffinate from the UDEX extraction process on the catalytic reformer stream. It consists of saturated hydrocarbons having carbon numbers predominantly in the range of C6 through C9.]
A complex combination of hydrocarbons obtained as the raffinate from the UDEX extraction process on the catalytic reformer stream. It consists of saturated hydrocarbons having carbon numbers predominantly in the range of C6 through C9.
270-088-5
68410-71-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Raffinates (petroleum), reformer, Lurgi unit-sepd.; Low boiling point modified naphtha [he complex combination of hydrocarbons obtained as a raffinate from a Lurgi separation unit. It consists predominantly of non-aromatic hydrocarbons with various small amounts of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8.]
The complex combination of hydrocarbons obtained as a raffinate from a Lurgi separation unit. It consists predominantly of non-aromatic hydrocarbons with various small amounts of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8.
270-349-3
68425-35-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Raffinates (petroleum), steam-cracked C4 fraction cuprous ammonium acetate extn., C3-5 and C3-5 unsatd., butadiene-free; Petroleum gas
307-769-4
97722-19-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
reaction mas of: 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-hydroxynaphthalene-2-sulfonic acid, Na/K salt; 7-amino-3-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-hydroxy-8-[4-(2-sulfoxyethylsulfonyl)-2-sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-8-[4-(2-sulfoxyethylsulfonyl)-phenylazo]-4-hydroxy-3-[4-(2-sulfoxyethylsulfonyl)-2-sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)-2-sulfophenylazo]-4-hydroxynaphthalene-2-sulfonic acid, Na/K salt
SCARLET DER 8107
429-070-4
214362-06-8
Eye Dam. 1
reaction mass (ratio not known) of: ammonium 1-C14-C18-alkyloxycarbonyl-2-(3-allyloxy-2-hydroxypropoxycarbonyl)ethane-1-sulfonate; ammonium 2-C14-C18-alkyloxycarbonyl-1-(3-allyloxy-2-hydroxypropoxycarbonyl)ethane-1-sulfonate
LATEMUL S-180 A
410-540-2
116726-92-2
Skin Irrit. 2; Skin Sens. 1
reaction mass of (S)-Indoxacarb and (R)-Indoxacarb 75:25; methyl 7-chloro-2-{(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]carbamoyl}-2,5-dihydroindeno[1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate [2]
604-398-2
144171-61-9
Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Sens. 1B
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 1-[2-(2-aminobutoxy)ethoxy]but-2-ylamine and 1-({[2-(2-aminobutoxy)ethoxy]methyl}propoxy)but-2-ylamine
447-920-2
897393-42-9
Repr. 2; Acute Tox. 4; Skin Corr. 1B; Eye Dam. 1
reaction mass of 2,2-iminodiethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate and 2-methylaminoethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate and N, N-diethylpropane-1,3-diamine 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate
C.I. DIRECT YELLOW 166; DIRECT YELLOW 166; GIALLO DIRETTO 166; JAUNE DIRECT 166; MONOAZO YELLOW MA 2822
403-410-1
114565-65-0
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-(sec-butyl)-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane and 5-(sec-butyl)-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane;Reaction mass of 5-[(2R)-butan-2-yl]-2-[(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1R,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane
413-720-9
117933-89-8
yes
Reaction mass of 5-(sec-butyl)-2-(2,4-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane and 5-(sec-butyl)-2-(4,6-dimethylcyclohex-3-en-1-yl)-5-methyl-1,3-dioxane;Reaction mass of 5-[(2R)-butan-2-yl]-2-[(1R,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1R,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2R)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2R)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane and 5-[(2S)-butan-2-yl]-2-[(1S,2S)-2,4-dimethylcyclohex-3-en-1-yl]-5-methyl-1,3-dioxane
413-720-9
117933-89-8
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 7-[4-(3-diethylaminopropylamino)-6-(3-diethylammoniopropylamino)-1,3,5-triazin-2-ylamino]-4-hydroxy-3-(4-phenylazophenylazo)-naphthalene-2-sulfonate, acetic acid, lactic acid (2:1:1)
CARTASOL RED K-2BN; RED 10 25 501
408-000-6
118658-98-3
STOT RE 2; Skin Sens. 1
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 compounds from (dodecakis(p-tolylthio)phthalocyaninato)copper(II)to (hexadecakis(p-tolylthio)phthalocyaninato)copper(II)
PROJET 780 NP; SUBSTANCE SC101756
407-700-9
101408-30-4
Skin Sens. 1
reaction mass of disodium 6-(2,4-dihydroxyphenylazo)-3-(4-(4-(2,4-dihydroxyphenylazo)anilino)-3-sulphonatophenylazo)-4-hydroxynaphthalene-2-sulphonate and disodium 6-(2,4-diaminophenylazo)-3-(4-(4-(2,4-diaminophenylazo)anilino)-3-sulphonatophenylazo)-4-hydroxynaphthalene-2-sulphonate and trisodium 6-(2,4-dihydroxyphenylazo)-3-(4-(4-(7-(2,4-dihydroxyphenylazo)-1-hydroxy-3-sulphonato-2-naphthylazo)anilino)-3-sulphonatophenylazo)-4-hydroxynaphthalene-2-sulphonate
C.I. DIRECT BLACK 174
400-570-4
162994-84-5
Eye Irrit. 2
reaction mass of dodecyl 3-(2,2,4,4-tetramethyl-21-oxo-7-oxa-3,20-diazadispiro(5,1,11,2)henicosan-20-yl)propionate and tetradecyl 3-(2,2,4,4-tetramethyl-21-oxo-7-oxa-3,20-diazadispiro(5,1,11,2)henicosan-20-yl)propionate
HOSTAVIN N 24; SANDUVOR 3050; VP SANDUVOR 3050
400-580-9
85099-50-9
Skin Irrit. 2
reaction mass of esters of 5,5',6,6',7,7'-hexahydroxy-3,3,3',3'-tetramethyl-1,1'-spirobiindan and 2-diazo-1,2-dihydro-1-oxo-5-sulfonaphthalene
PS-6 SENSITIZER
413-840-1
121870-66-4
Self-react. C
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 branched tetracosane
1-DODECENE DIMER, HYDROGENATED; ALKANE 2
417-060-2
151006-61-0
Acute Tox. 4
reaction mass of isomers of: methyldiphenylmethane; dimethyldiphenylmethane
MARLOTHERM L
405-470-4
73807-39-3
Skin Irrit. 2
reaction mass of isomers of: mono-(2-tetradecyl)naphthalenes; di-(2-tetradecyl)naphthalenes; tri-(2-tetradecyl)naphthalenes
MCP 968
410-190-0
132983-41-6
Eye Irrit. 2
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 O, O'-diisopropyl (pentathio)dithioformate and O, O'-diisopropyl (trithio)dithioformate and O, O'-diisopropyl (tetrathio)dithioformate
ROBAC AS/100
403-030-6
137398-54-0
Acute Tox. 4; Skin Sens. 1
reaction mass of pentyl methylphosphinate and 2-methylbutyl methylphosphinate
MPA
402-090-0
87025-52-3
Skin Corr. 1B
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: (1'α, 3'α, 6'α)-2,2,3' ,7', 7'-pentamethylspiro(1,3-dioxane-5,2'-norcarane); (1'α, 3'β, 6'α)-2,2,3', 7', 7'-pentamethylspiro(1,3-dioxane-5,2'-norcarane)
SPIRAMBRENE
416-930-9
121251-67-0
Skin Irrit. 2
reaction mass of: (1RS, 2RS,3SR, 6RS, 9SR)-9-methoxytricyclo[5.2.1.0(2,6)]decane-3-carbaldehyde; (1RS, 2RS, 3RS, 6RS, 8SR)-8-methoxytricyclo[5.2.1.0(2,6)]decane-3-carbaldehyde; (1RS, 2RS, 4SR, 6RS, 8SR)-8-methoxytricyclo[5.2.1.0(2,6)]decane-4-carbaldehyde
429-860-9
86803-90-9
Skin Sens. 1
reaction mass of: (1RS, 2SR,7SR, 8SR, E) 9 and 10-ethylidene-3-oxatricyclo[6.2.1.0(2,7)]undecan-4-one; (1RS, 2SR, 7SR, 8SR, Z)-10-ethylidene-3-oxatricyclo[6.2.1.0(2,7)]undecan-4-one; (1RS, 2SR, 7SR, 8SR, Z)-9-ethylidene-3-oxatricyclo[6.2.1.0(2,7)]undecan-4-one
434-290-9
249630-78-2
Acute Tox. 4
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