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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
tetrakis(trimethylhexadecylammonium) hexa-mu-oxotetra-mu3-oxodi-mu5-oxotetradecaoxooctamolybdate(4-)
TP-302
404-860-1
116810-46-9
Flam. Sol. 1; Eye Dam. 1
Tetralead trioxide sulphate
235-380-9
12202-17-4
yes
tetralithium 6-amino-4-hydroxy-3-(7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo)naphthalene-2,7-disulfonate
FOOD BLACK 2, LITHIUM SALT
405-150-4
106028-58-4
Skin Sens. 1
tetramethylene diacrylate; 1,4-butyleneglycol diacrylate
213-979-6
1070-70-8
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
tetraphosphorus trisulphide; phosphorus sesquisulphid
215-245-0
1314-85-8
Flam. Sol. 2; Water-react. 1; Acute Tox. 4
tetrapotassium 2-(4-(5-(1-(2,5- disulfonatophenyl)-3-ethoxycar bonyl-5-hydroxypyrazol-4- yl)penta-2,4-dienylidene)-3- ethoxycarbonyl-5-oxo-2-pyra zolin-1-yl)benzene-1,4- disulfonate
1291-F; FUCD-4
405-240-3
160683-19-2
Skin Sens. 1
tetrapropan-2-yl (dichloromethanediyl)bis(phosphonate)
430-630-5
10596-22-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
tetrasodium (c-(3-(1-(3-(e-6-dichloro-5-cyanopyrimidin-f-yl(methyl)amino)propyl)-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridylazo)-4-sulfonatophenylsulfamoyl)phthalocyanine-a, b,d-trisulfonato(6-))nickelato II, where a is 1 or 2 or 3 or 4,b is 8 or 9 or 10 or 11,c is 15 or 16 or 17 or 18, d is 22 or 23 or 24 or 25 and where e and f together are 2 and 4 or 4 and 2 respectively
BRILLANTGREEN K-RWA 6083; BRILLIANT GREEN K-RWA 6083
410-160-7
148732-74-5
Eye Irrit. 2; Skin Sens. 1
tetrasodium 1,2-bis(4-fluoro-6- [5-(1-amino-2-sulfonatoanthra chinon-4-ylamino)-2,4,6- trimethyl-3-sulfonatopheny lamino]-1,3,5-triazin-2- ylamino)ethane
BLEU REACTIF TZ 3533; BLEU REACTIVE TZ 3533; FAT 41'017/A; REACTIVE BLUE TZ 3533
411-240-4
143683-23-2
Skin Sens. 1
tetrasodium 10-amino-6,13-dichloro-3-(3-(4-(2,5-disulfonatoanilino)-6-fluoro-1,3,5-triazin-2-ylamino)prop-3-ylamino)-5,12-dioxa-7,14-diazapentacene-4,11-disulfonate
BLEU DIOXAZINA ST 7005; BLEU DIOXAZINE ST 7005; DIOXAZIN BLAU ST 7005; DIOXAZINE BLUE ST 7005
402-590-9
109125-56-6
Eye Dam. 1
tetrasodium 4-[4-chloro-6-(4-methyl-2-sulfophenylamino)-1,3,5-triazin-2-ylamino]-6-(4,5-dimethyl-2-sulfophenylazo)-5-hydroxynaphthalene-2,7-disulfonate
AZO MONOCHLOROTRIAZINYL REACTIVE DYE; PROCION RED PX-6B COLOUR; SUBSTANCE S161057
415-400-4
148878-22-2
Eye Dam. 1; Skin Sens. 1
tetrasodium 4-amino-5-hydroxy-6-(4-(2-(2-(sulfonatooxy)ethylsulfonyl)ethylcarbamoyl)phenylazo)-3-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-2,7-disulfonate
BLEU REACTIF 238; BLEU REATTIVO 238; C.I. REACTIVE BLUE 238; DISAZO MARINE TZ 2646; MARINE DIAZO TZ 2646; REACTIVE BLUE 238
404-320-5
116889-78-2
Skin Sens. 1
tetrasodium 4-hydroxy-5-[4-[3-(2-sulfatoethanesulfonyl)phenylamino]-6-morpholin-4-yl-1,3,5-triazin-2-ylamino]-3-(1-sulfonatonaphthalen-2-ylazo)naphthalene-2,7-disulfonate
REACTIVE RED 202 (ESTER)
413-070-6
1379676-82-0
Skin Sens. 1
tetrasodium 5-(4,6-dichloro-5-cyanopyrimidin-2-ylamino)-4-hydroxy-2,3-azodinaphthalene-1,2,5,7-disulphonate
C.I. REACTIVE RED 219
400-130-1
149057-72-7
Resp. Sens. 1
tetrasodium 5-[4-chloro-6-(N-ethyl-anilino)-1,3,5-triazin-2-ylamino]-4-hydroxy-3-(1,5-disulfonatonaphthalen-2-ylazo)-naphthalene-2,7-disulfonate
REACTIVE RED SR 6947; ROUGE REACTIF SR 6947
411-540-5
130201-57-9
Eye Dam. 1; Skin Sens. 1
tetrasodium [7-(2,5-dihydroxy-KO2-7-sulfonato-6-[4-(2,5,6-trichloro-pyrimidin-4-ylamino)phenylazo]-(N1,N7-N)1-naphthylazo)-8-hydroxy-KO8-naphthalene-1,3,5-trisulfonato(6)]cuprate(II)
NAVY 14 05 711
411-470-5
141048-13-7
Skin Sens. 1
tetrasodium dihydrogen 1,1''-dihydroxy-8,8''-[p-phenylbis(imino-{6-[4-(2-aminoethyl)piperazin-1-yl]}-1,3,5-triazine-4,2-diyl-imino)]bis(2,2'-azonaphthalene-1',3,6-trisulfonate)
RED ULK 1640
420-350-1
172277-97-3
Eye Dam. 1
thiacloprid (ISO); (Z)-3-(6-chloro-3-pyridylmethyl)-1,3-thiazolidin-2-ylidenecyanamide; {(2Z)-3-[(6-chloropyridin-3-yl)methyl]-1,3-thiazolidin-2-ylidene}cyanamide
601-147-9
111988-49-9
Carc. 2; Repr. 1B; Acute Tox. 4; Acute Tox. 3; STOT SE 3
thiamethoxam (ISO); 3-(2-chloro-thiazol-5-ylmethyl)-5-methyl[1,3,5]oxadiazinan-4-ylidene-N-nitroamine
428-650-4
153719-23-4
Acute Tox. 4
thionyl chloride, reaction products with 1,3,4-thiadiazol-2,5-dithiol, tert-nonanethiol andC 12-14-tert-alkylamine
RT 1766A
404-820-3
164637-97-2
Skin Irrit. 2; Skin Sens. 1
thiram (ISO); tetramethylthiuram disulphide
205-286-2
137-26-8
Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
titanium dioxide [in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm]
236-675-5
13463-67-7
Carc. 2
toluene
203-625-9
108-88-3
Flam. Liq. 2; Repr. 2; Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; STOT SE 3
tosylchloramide sodium
204-854-7
127-65-1
Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1
trans-(4S,6S)-5,6-dihydro-6-methyl-4H-thieno[2,3-b]thiopyran-4-ol, 7,7-dioxide
FC4010
417-290-3
147086-81-5
Acute Tox. 4
trans-cyclohexane-1,2-dicarboxylic anhydride
238-009-9
14166-21-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
trans-dichloroethylene
205-860-2
156-60-5
Flam. Liq. 2; Acute Tox. 4
trans-methyl-2-ethyl-but-2-enoate
443-150-6
101226-85-1
Flam. Liq. 3
transfluthrin (ISO); 2,3,5,6-tetrafluorobenzyl trans-2-(2,2-dichlorovinyl)-3,3-dimethylcyclopropanecarboxylate
405-060-5
118712-89-3
Skin Irrit. 2
trans—N-methyl-2-styryl-[4'- aminomethine-(1-acetyl-1-(2- methoxyphenyl)acetamido)]py ridinium acetate
BASIC YELLOW 105; C.I. BASIC YELLOW 105
405-860-4
121315-16-0
Skin Sens. 1
triamiphos (ISO); 5-amino-3-phenyl-1,2,4-triazol-1-yl-N, N,N',N'-tetramethylphosphonic diamide
620-368-1
1031-47-6
Acute Tox. 1; Acute Tox. 2
tribenuron-methyl (ISO); 2-[4-methoxy-6-methyl-1,3,5-triazin-2-yl(methyl)carbamoylsulfamoyl]benzoic acid methyl ester; methyl 2-(3-(4-methoxy-6-methyl-1,3,5-triazin-2-yl)-3methylureidosulfonyl)benzoate
401-190-1
101200-48-0
STOT RE 2; Skin Sens. 1
tributyl phosphate
204-800-2
126-73-8
Carc. 2; Acute Tox. 4; Skin Irrit. 2
tributyltetradecylphosphonium tetrafluoroborate
D 27-046
413-520-1
125792-14-5
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
trichlorosilane
233-042-5
10025-78-2
Flam. Liq. 1; Pyr. Liq. 1; Acute Tox. 4; Skin Corr. 1A
tricresyl phosphate (m-m-m-, m-m-p-, m-p-p-, p-p-p-); tritolyl phosphate (m-m-m-, m-m-p-, m-p-p-, p-p-p-);tricresyl phosphate (o-o-o-, o-o-m-, o-o-p-, o-m-m-, o-m-p-, o-p-p-); tritolyl phosphate (o-o-o-, o-o-m-, o-o-p-, o-m-m-, o-m-p-, o-p-p-)
215-548-8
1330-78-5
STOT SE 1
tricresyl phosphate (m-m-m-, m-m-p-, m-p-p-, p-p-p-); tritolyl phosphate (m-m-m-, m-m-p-, m-p-p-, p-p-p-);tricresyl phosphate (o-o-o-, o-o-m-, o-o-p-, o-m-m-, o-m-p-, o-p-p-); tritolyl phosphate (o-o-o-, o-o-m-, o-o-p-, o-m-m-, o-m-p-, o-p-p-)
215-548-8
1330-78-5
Acute Tox. 4
triethoxyisobutylsilane
DYNASILAN BH N; DYNASILAN BSM 100 N; DYNASILAN NH 42
402-810-3
17980-47-1
Skin Irrit. 2
triethyl arsenate
TRIETHYLARSENAT; TRIETHYLARSENATE; TRIETHYLARSENATE (TEASAT)
427-700-2
15606-95-8
Carc. 1A; Acute Tox. 3
yes
triethylamine
204-469-4
121-44-8
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
trifenmorph (ISO);4-tritylmorpholine
215-812-2
1420-06-0
Acute Tox. 4
trifloxystrobin (ISO); (E, E)-α-methoxyimino-2-[[[[[1-[3-(trifluoromethyl)phenyl]ethylidene]amino]oxy]methyl]benzeneacetic acid methyl ester
604-237-6
141517-21-7
Skin Sens. 1
trifluralin (ISO) (containing <0.5 ppm NPDA); α, α, α-trifluoro-2,6-dinitro-N, N-dipropyl-p-toluidine (containing; < 0,5 ppm NPDA); 2,6-dinitro-N, N-dipropyl-4-trifluoromethylaniline (containing < 0,5 ppm NPDA); N, N-dipropyl-2,6-dinitro-4-trifluoromethylaniline (containing < 0.5 ppm NPDA)
216-428-8
1582-09-8
Carc. 2; Skin Sens. 1
triflusulfuron-methyl; methyl 2-({[4-(dimethylamino)-6- (2,2,2-trifluoroethoxy)-1,3,5- triazin-2-yl]carbamoyl}sulfamoyl)-3-methylbenzoate
603-146-9
126535-15-7
Carc. 2
trihydrogen hydroxybis[orthosilicato(4-)]trinickelate(3-)
235-688-3
12519-85-6
Carc. 1A; STOT RE 1; Skin Sens. 1
Trilead bis(carbonate)dihydroxide
215-290-6
1319-46-6
yes
Trilead dioxide phosphonate
235-252-2
12141-20-7
yes
trilithium bis(4-((4-(diethylamino)-2-hydroxyphenyl)azo)-3-hydroxy-1-naphthalenesulfonato(3-))chromate(3-)
ACID BLUE FC 77890
414-290-5
149564-65-8
Acute Tox. 4
trilithium-1-hydroxy-7-(3-sulfonatoanilino)-2-(3-methyl-4-(2-methoxy-4-(3-sulfonatophenylazo)phenylazo)phenylazo)naphthalene-3-sulfonate
IJA-286; IJBK-286; IJBK-286-LI
403-650-7
117409-78-6
Expl. 1.3
trimethyl borate
204-468-9
121-43-7
Flam. Liq. 3; Acute Tox. 4
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