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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 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
tetrasodium 3,3'-[[1,1'-biphenyl]-4,4'diylbis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate]; C.I. Direct Blue 6
220-012-1
2602-46-2
Carc. 1B; Repr. 2
tetrasodium 4,4'-bis{4-[4-(2-hydroxyethylamino)-6-(4-sulfonatoanilino)-1,3,5-triazin-2-ylamino]phenylazo}stilbene-2,2'-disulfonate
429-230-3
371921-41-4
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-3,6-bis(5-(6-chloro-4-(2-hydroxyethylamino)-1,3,5-triazin-2-ylamino)-2-sulfonatophenylazo)-5-hydroxynaphthalene-2,7-sulfonate (containing > 35 % sodium chloride and sodium acetate)
BLEU MARINE DRIMARENE X-GN PKT; BLEU MARINE X-VT 4046; DRIMAREN MARINEBLAU X-GN PKT; DRIMAREN NAVY X-GN PKT; NAVY BLUE X-VT 4046
400-510-7
85665-98-1
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 5-benzamido-3-(5-(4-fluoro-6-(1-sulphonato-2-naphthylamino)-1,3,5-triazin-2-ylamino)-2-sulphonatophenylazo)-4-hydroxynaphthalene-2,7-disulphonate
C.I. REACTIVE RED 220; CIBACRON-RED F-2G; CIBACRON-ROT F-2G; REACTIVE RED 220; ROSSO REATTIVO 220; ROUGE REACTIF 220
400-790-0
85665-97-0
Eye Irrit. 2; Skin Irrit. 2; 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
tetrasodium ethylene diamine tetraacetate
200-573-9
64-02-8
Acute Tox. 4; Eye Dam. 1
thallium
231-138-1
7440-28-0
Acute Tox. 2; STOT RE 2
thallium compounds, with the exception of those specified elsewhere in this Annex
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Dithallium carbonate EC / List no: 229-434-0 | CAS no: 6533-73-9
Dithallium sulphide EC / List no: 215-250-8 | CAS no: 1314-97-2
(pentane-2,4-dionato-O,O')thallium EC / List no: 238-081-1 | CAS no: 14219-90-0
Dithallium telluride EC / List no: 234-916-9 | CAS no: 12040-13-0
Dithallium sulphate EC / List no: 231-201-3 | CAS no: 7446-18-6
Dithallium trisulphide EC / List no: 234-886-7 | CAS no: 12039-17-7
Thallium phosphate EC / List no: 257-461-8 | CAS no: 51833-34-2
Antimony, compound with thallium (1:1) EC / List no: 249-428-1 | CAS no: 29095-38-3
Thallium bromide EC / List no: 232-163-0 | CAS no: 7789-40-4
Leach residues, zinc refining flue dust, cadmium-thallium ppt.
Sponge produced by leaching and precipitating cadmium and thallium fumes and flue dusts from lead/zinc smelting operations.
EC / List no: 296-097-4 | CAS no: 92257-11-9
Dithallium trioxide EC / List no: 215-229-3 | CAS no: 1314-32-5
Mercury thallium dinitrate EC / List no: 301-543-9 | CAS no: 94022-47-6
Thallium (I) ethanolate EC / List no: 243-786-2 | CAS no: 20398-06-5
2-Butanol, 2-methyl-, thallium(1+) salt EC / List no: - | CAS no: 75222-21-8
Thallium(III) trifluoroacetate EC / List no: 245-761-1 | CAS no: 23586-53-0
Sulfuric acid, thallium(3+) salt (2:1) EC / List no: - | CAS no: 15478-75-8
Thallium(3+) perchlorate EC / List no: 239-677-4 | CAS no: 15596-83-5
Sulfuric acid, thallium salt EC / List no: - | CAS no: 10031-59-1
Dithallium difluoride EC / List no: - | CAS no: 31970-97-5
Thallium trinitrate EC / List no: 237-325-4 | CAS no: 13746-98-0
Thallium nitrate EC / List no: 233-273-1 | CAS no: 10102-45-1
Dithallium dichromate EC / List no: 236-626-8 | CAS no: 13453-35-5
Thallium hydroxide EC / List no: 234-708-8 | CAS no: 12026-06-1
Selenious acid, dithallium(1+) salt EC / List no: - | CAS no: 15123-92-9
Thallium acetate EC / List no: 239-947-1 | CAS no: 15843-14-8
Thallium telluride (TlTe) EC / List no: - | CAS no: 12040-12-9
lambda1-thallanylium hexafluoro-lambda5-phosphanuide EC / List no: 633-081-1 | CAS no: 60969-19-9
Thallium acetate EC / List no: 209-257-5 | CAS no: 563-68-8
Niobium thallium trioxide EC / List no: 235-634-9 | CAS no: 12396-77-9
2-fluoroacetate;thallium(1+) EC / List no: - | CAS no: 63905-90-8
Thallium (201Tl) Chloride Injection EC / List no: - | CAS no: 55172-29-7
Thallium triarsenide EC / List no: 281-902-3 | CAS no: 84057-85-2
Thallium triiodide EC / List no: 236-627-3 | CAS no: 13453-37-7
Trimethyl thallium EC / List no: - | CAS no: 3003-15-4
Thallium trichloride EC / List no: 236-625-2 | CAS no: 13453-32-2
Thallium formate EC / List no: 213-599-0 | CAS no: 992-98-3
Sulfuric acid, thallium(3+) salt (2:1), dihydrate EC / List no: - | CAS no: 87963-73-3
Cyclopentadienylthallium EC / List no: 252-229-2 | CAS no: 34822-90-7
Sulfuric acid, thallium(1+) tin(2+) salt (2:2:1) EC / List no: - | CAS no: 27790-36-9
Thallic nitrate, trihydrate EC / List no: 627-221-0 | CAS no: 13453-38-8
Thallium iodide (TlI2) EC / List no: - | CAS no: 57232-83-4
Carbamic acid, diethyldithio-, thallium complex EC / List no: - | CAS no: 18756-72-4
Thallium (III) acetate sesquihydrate EC / List no: 219-913-2 | CAS no: 2570-63-0
Sulfuric acid, thallium(3+) salt (2:1), tetrahydrate EC / List no: - | CAS no: 37667-57-5
Sulfuric acid, aluminum thallium salt EC / List no: - | CAS no: 52238-56-9
Slimes and Sludges, thallium carbonate EC / List no: - | CAS no: 69029-96-5
Dithallium oxide EC / List no: 215-220-4 | CAS no: 1314-12-1
Bismuth thallium( 1) cation pentadecaiodide EC / List no: - | CAS no: 67338-06-1
Oxalic acid dithallium(I) salt EC / List no: 680-447-1 | CAS no: 30737-24-7
Thallium thiocyanate EC / List no: 222-571-7 | CAS no: 3535-84-0
Dithallium selenide EC / List no: 239-627-1 | CAS no: 15572-25-5
Thallium hydrogen carbonate EC / List no: 249-868-4 | CAS no: 29809-42-5
Thallium iodide EC / List no: 232-199-7 | CAS no: 7790-30-9
Thallium(i) metaborate EC / List no: - | CAS no: 16979-36-5
Dithallium chromate EC / List no: 236-750-2 | CAS no: 13473-75-1
Nitric acid, thallium salt EC / List no: - | CAS no: 16901-76-1
Silver thallium dinitrate EC / List no: 247-283-9 | CAS no: 25822-21-3
Thallium telluride (Tl2Te3) EC / List no: - | CAS no: 12040-16-3
Residues, thallium EC / List no: - | CAS no: 69029-81-8
Thallium(3+) triformate EC / List no: 276-195-3 | CAS no: 71929-23-2
Dithallium malonate EC / List no: 220-414-7 | CAS no: 2757-18-8
Chloric acid, thallium(1+) salt EC / List no: - | CAS no: 13453-30-0
Slimes and Sludges, thallium
Product of adding a sulfidizer to a thallium-rich solution during lead refining. Consists primarily of thallium and cadmium sulfides.
EC / List no: 273-835-3 | CAS no: 69029-95-4
Thallium fluoride EC / List no: 232-154-1 | CAS no: 7789-27-7
Bismuth, compound with thallium (1:1) EC / List no: 234-982-9 | CAS no: 12048-36-1
Thallium arsenide EC / List no: 234-481-5 | CAS no: 12006-09-6
m-Toluic acid, alpha,alpha,alpha-trifluoro-, thallium salt EC / List no: - | CAS no: 63980-13-2
Thallium chloride EC / List no: 232-241-4 | CAS no: 7791-12-0
Thallium(1+) propan-2-olate EC / List no: 254-386-2 | CAS no: 39262-04-9
Dithallium tris(sulphate) EC / List no: 240-349-8 | CAS no: 16222-66-5
Sulfuric acid, thallium(2+) salt EC / List no: - | CAS no: 37475-01-7
Thallium, (4-methylphenyl)bis(trifluoroacetato-O)- EC / List no: 631-044-4 | CAS no: 23586-55-2
Thallium selenide EC / List no: 234-895-6 | CAS no: 12039-52-0
Perrhenic acid, thallium salt EC / List no: 683-357-0 | CAS no: 14013-75-3
Thallium iodate EC / List no: 238-831-8 | CAS no: 14767-09-0
Thallium hydrotris(1-pyrazolyl)borate EC / List no: - | CAS no: 34269-45-9
Sulfuric acid, thallium(3+) salt (2:1), monohydrate EC / List no: - | CAS no: 37667-58-6
Thallium trifluoride EC / List no: 232-010-8 | CAS no: 7783-57-5
Thallium tribromide EC / List no: 237-232-9 | CAS no: 13701-90-1
Waste solids, cadmium-electrolysis, thallium-rich
Residue obtained in the electrolysis of cadmium, composed primarily of thallium chromate. Other non-ferrous metals or metal compounds may also be present.
EC / List no: 285-572-1 | CAS no: 85117-20-0
-
-
Acute Tox. 2; STOT RE 2
thallium thiocyanate
222-571-7
3535-84-0
Acute Tox. 2; Acute Tox. 4; STOT RE 2
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
thiazafluron (ISO); 1,3-dimethyl-1-(5-trifluoromethyl-1,3,4-thiadiazol-2-yl)urea
246-901-4
25366-23-8
Acute Tox. 4
thioacetamide
200-541-4
62-55-5
Carc. 1B; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
thiobencarb (ISO); S-4-chlorobenzyl diethylthiocarbamate
248-924-5
28249-77-6
Acute Tox. 4
thiocarbonyl chloride
207-341-6
463-71-8
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
thiocyanic acid
207-337-4
463-56-9
Acute Tox. 4
thiofanox (ISO); 3,3-dimethyl-1-(methylthio)butanone-O-(N-methylcarbamoyl)oxime
254-346-4
39196-18-4
Acute Tox. 1; Acute Tox. 2
thioglycolic acid
200-677-4
68-11-1
Acute Tox. 3; Skin Corr. 1B
thiometon (ISO); S-2-ethylthioethyl O,O-dimethyl phosphorodithioate
211-362-6
640-15-3
Acute Tox. 3; Acute Tox. 4
thionazin (ISO); O,O-diethyl O-pyrazin-2-yl phosphorothioate
206-049-6
297-97-2
Acute Tox. 1; Acute Tox. 2
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
thionyl dichloride; thionyl chloride
231-748-8
7719-09-7
Acute Tox. 4; Skin Corr. 1A
thiophanate-methyl (ISO); 1,2-di-(3-methoxycarbonyl-2-thioureido)benzene
245-740-7
23564-05-8
Muta. 2; Acute Tox. 4; Skin Sens. 1
thioquinox(ISO); 2-thio-1,3-dithiolo(4,5,b)quinoxaline
202-272-8
93-75-4
Acute Tox. 4
thiourea; thiocarbamide
200-543-5
62-56-6
Carc. 2; Repr. 2; Acute Tox. 4
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
thymol
201-944-8
89-83-8
Acute Tox. 4; Skin Corr. 1B
Tick-borne orthomyxoviridae: Dhori and Thogoto
-
-
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.
tin tetrachloride; stannic chloride
231-588-9
7646-78-8
Skin Corr. 1B
tin(II) methanesulphonate
STANNOUS METHANE SULPHONAT; STANNOUS METHANE SULPHONATE; TIN (II) METHANE SULPHONATE; TIN METHANE SULPHONATE; TIN METHANESULFONATE; TIN SALT FS; ZINN(II) METHANESULFONATE; ZINN(II)-METHANSULFONAT
401-640-7
53408-94-9
Skin Corr. 1B; Acute Tox. 4; 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
titanium tetrachloride
231-441-9
7550-45-0
Skin Corr. 1B
titanium(4+) oxalate
TITANYL OXALAAT
403-260-7
31363-92-5
Eye Dam. 1
tolclofos-methyl (ISO); O-(2,6-dichloro-p-tolyl)-O,O-dimethyl thiophosphate
260-515-3
57018-04-9
Skin Sens. 1
toluene
203-625-9
108-88-3
Flam. Liq. 2; Repr. 2; Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; STOT SE 3
toluene-2,4-diammonium sulphate; 4-methyl-m-phenylenediamine sulfate
265-697-8
65321-67-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
toluidine sulphate (1:1)
208-741-3
540-25-0
Carc. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
toluidinium chloride
208-740-8
540-23-8
Carc. 2; Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
tolylfluanid (ISO);dichloro-N-[(dimethylamino)sulphonyl]fluoro-N-(p-tolyl)methanesulphenamide;[containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];tolylfluanid (ISO);dichloro-N-[(dimethylamino)sulphonyl]fluoro-N-(p-tolyl)methanesulphenamide;[containing ≥0.1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
211-986-9
731-27-1
Acute Tox. 2; STOT RE 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
tolylfluanid (ISO);dichloro-N-[(dimethylamino)sulphonyl]fluoro-N-(p-tolyl)methanesulphenamide;[containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];tolylfluanid (ISO);dichloro-N-[(dimethylamino)sulphonyl]fluoro-N-(p-tolyl)methanesulphenamide;[containing ≥0.1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
211-986-9
731-27-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Tonate 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.
Toroviridae
-
-
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.
Toscana 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.
tosylchloramide sodium
204-854-7
127-65-1
Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1
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