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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 26 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
divanadium pentaoxide; vanadium pentoxide
215-239-8
1314-62-1
Muta. 2; Repr. 2; STOT RE 1; Acute Tox. 4; STOT SE 3
dodecyl 3,4,5-trihydroxybenzoate
214-620-6
1166-52-5
Skin Sens. 1
dodecyl methacrylate
205-570-6
142-90-5
STOT SE 3
dodemorph (ISO); 4-cyclododecyl-2,6-dimethylmorpholine
216-474-9
1593-77-7
Repr. 2; STOT RE 2; Skin Corr. 1C; Skin Sens. 1A
E-ethyl-4-oxo-4-phenylcrotonate
BAE; BENZOYLACRYLATE D'ETHYLE; BENZOYLACRYLATE D'ÉTHYLE (TRANS); BENZOYLACRYLIC ACID ETHYL ESTER; BENZOYLACRYLSÄURE ETHYLESTER
408-040-4
15121-89-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
edifenphos (ISO); O-ethyl S, S-diphenyl phosphorodithioate
241-178-1
17109-49-8
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
endosulfan (ISO); 1,2,3,4,7,7-hexachloro-8,9,10-trinorborn-2-en-5,6-ylenedimethylene sulfite; 1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-en-2,3-ylenedimethylene sulfite
204-079-4
115-29-7
Acute Tox. 2; Acute Tox. 4
endothal (ISO); 7-oxabicyclo(2,2,1)heptane-2,3-dicarboxylic acid
205-660-5
145-73-3
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
endothal-sodium (ISO); disodium 7-oxabicyclo(2,2,1)heptane-2,3-dicarboxylate
204-959-8
129-67-9
Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
epoxiconazole (ISO); (2RS,3SR)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-[(1H-1,2,4-triazol-1-yl)methyl]oxirane
406-850-2
133855-98-8
Carc. 2; Repr. 1B
erbon (ISO); 2-(2,4,5-trichlorophenoxy)ethyl2,2-dichloropropionate
-
136-25-4
Acute Tox. 4
erionite
620-440-2
12510-42-8
Carc. 1A
ethanediol; ethylene glycol
203-473-3
107-21-1
Acute Tox. 4
ethephon; 2-chloroethylphosphonic acid
240-718-3
16672-87-0
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1C
ethidium bromide; 3,8-diamino-1-ethyl-6-phenylphenantridinium bromide
214-984-6
1239-45-8
Muta. 2; Acute Tox. 2; Acute Tox. 4
ethoate-methyl (ISO); ethylcarbamoylmethyl O,O-dimethyl phosphorodithioate
204-121-1
116-01-8
Acute Tox. 4
ethoprophos (ISO); ethyl-S,S-dipropyl phosphorodithioate
236-152-1
13194-48-4
Acute Tox. 2; Acute Tox. 1; Acute Tox. 3; Skin Sens. 1
ethyl (3-cyanomethyl-3,4-dihydro-4-oxophthalazin-1-yl)acetate
429-680-0
122665-86-5
Skin Sens. 1
ethyl (3R)-4-cyano-3-hydroxybutanoate
430-220-6
141942-85-0
Eye Irrit. 2
ethyl 1-(2,4-dichlorophenyl)-5-(trichloromethyl)-1H-1,2,4-triazole-3-carboxylate
HOE 70542
401-290-5
103112-35-2
Carc. 1B
ethyl 1-ethyl-6,7,8-trifluoro-1,4-dihydro-4-oxoquinoline-3-carboxylate
DM-8
405-880-3
100501-62-0
Skin Sens. 1
ethyl 2-(1-cyanocyclohexyl)acetate
GABAPENTINE ETHYL ESTER; PD 137016
415-970-4
133481-10-4
Acute Tox. 4; STOT RE 2
ethyl 2-(4-phenoxyphenyl)lactate
429-220-9
132584-17-9
Skin Sens. 1
ethyl 2-carboxy-3-(2-thienyl)propionate
SB-201999
415-680-8
143468-96-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
ethyl 5,5-diphenyl-2-isoxazoline-3-carboxylate
443-870-0
163520-33-0
Acute Tox. 4; Skin Sens. 1
ethyl 6,8-dichlorooctanoate
6,8-DICHLORETHYLCAPRYLAT; ETHYL-6,8 DICHLORO OCTANOATE
435-080-1
1070-64-0
Skin Sens. 1
ethyl 7-chloro-1-(2,4-difluorophenyl)-6-fluoro-1,4-dihydro-4-oxo-1,8-naphthyridine-3-carboxylate
422-360-1
100491-29-0
Skin Sens. 1
ethyl acetate
205-500-4
141-78-6
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
ethyl acrylate
205-438-8
140-88-5
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
ethyl bromoacetate
203-290-9
105-36-2
Acute Tox. 2; Acute Tox. 1
ethyl chloroacetate
203-294-0
105-39-5
Acute Tox. 3
ethyl formate
203-721-0
109-94-4
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
ethyl nitrite
203-722-6
109-95-5
Flam. Gas 1; Press. Gas; Acute Tox. 4
ethyl propionate
203-291-4
105-37-3
Flam. Liq. 2
ethyl propoxy aluminium chloride
EAPOXC
421-790-7
13014-29-4
Water-react. 1; Skin Corr. 1A
ethyl trans-3-dimethylaminoacrylate
BETA-DAASE; BETA-DIMETHYLAMIMO ACRYLIC ACID ETHYLESTER
402-650-4
1117-37-9
Skin Sens. 1
ethylbenzene
202-849-4
100-41-4
Flam. Liq. 2; Acute Tox. 4; STOT RE 2; Asp. Tox. 1
ethylenediamine; 1,2-diaminoethane
203-468-6
107-15-3
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
ethylenediammonium O, O-bis(octyl) phosphorodithioate, mixed isomers
Z-2
400-520-1
164907-74-8
Skin Corr. 1B; Acute Tox. 4
ethyleneimine; aziridine
205-793-9
151-56-4
Flam. Liq. 2; Carc. 1B; Muta. 1B; Acute Tox. 2; Acute Tox. 1; Skin Corr. 1B
Extract oils (coal), coal tar residual pyrolysis oils, naph thalene oil, distn. residues; Redistillates [Residue from the distillation of dephenolated and debased methylnaphthalene oil (from bituminous coal tar and pyrolysis residual oils) with a boiling range of 240 o C to 260o C (464°F to 500°F). Composed primarily of substituted dinuclear aromatic and heterocyclic hydrocarbons.]
Residue from the distillation of dephenolated and debased methylnaphthalene oil (from bituminous coal tar and pyrolysis residual oils) with a boiling range of 240°C to 260°C (464°F to 500°F). Composed primarily of substituted dinuclear aromatic and heterocyclic hydrocarbons.
310-171-6
122070-80-8
Carc. 1B; Muta. 1B
Extract oils (coal), coal tar-residual pyrolysis oils, naphthalene oils; Redistillates [ neutral oil obtained by debasing and dephenolating the oil obtained from the distillation of high temperature tar and pyrolysis residual oils which has a boiliing range of 225o C to 255o C (437°F to 491°F). Composed primarily of substituted dinuclear aromatic hydrocarbons.]
A neutral oil obtained by debasing and dephenolating the oil obtained from the distillation of high temperature tar and pyrolysis residual oils which has a boiliing range of 225°C to 255°C (437°F to 491°F). Composed primarily of substituted dinuclear aromatic hydrocarbons.
310-170-0
122070-79-5
Carc. 1B; Muta. 1B
Extract residues (coal tar), benzole fraction alk., acid ext.; Light Oil Extract Residues, low boiling [ complex combination of hydrocarbons obtained by the redistillation of the distillate of high temperature coal tar (tar acid and tar base free). It consists predominantly of unsubstituted and substituted mononuclear aromatic hydrocarbons boiling in the range of 85 °C to 195°C (185°F to 383°F).]
A complex combination of hydrocarbons obtained by the redistillation of the distillate of high temperature coal tar (tar acid and tar base free). It consists predominantly of unsubstituted and substituted mononuclear aromatic hydrocarbons boiling in the range of 85°C-195°C (185°F-383°F).
309-868-8
101316-63-6
Carc. 1B; Muta. 1B
Extract residues (coal), creosote oil acid; Wash Oil Extract Residue [ complex combination of hydrocarbons from the base-freed fraction from the distillation of coal tar, boiling in the range of approximately 250 °C to 280 °C (482°F to 536°F). It consists predominantly of biphenyl and isomeric diphenylnaphthalenes.]
A complex combination of hydrocarbons from the base-free fraction from the distillation of coal tar, boiling in the range of approximately 250°C to 280°C (482°F to 536°F). It consists predominantly of biphenyl and isomeric dimethylnaphthalenes.
310-189-4
122384-77-4
Carc. 1B
Extract residues (coal), light oil alk., acid ext., indene fraction; Light Oil Extract Residues, intermediate boiling
309-867-2
101316-62-5
Carc. 1B; Muta. 1B
Extract residues (coal), low temp. coal atar alk. [he residue from low temperature coal tar oils after an alkaline wash, such as aqueous sodium hydroxide, to remove crude coal tar acids. Composed primarily of hydrocarbons and aromatic nitrogen bases.]
The residue from low temperature coal tar oils after an alkaline wash, such as aqueous sodium hydroxide, to remove crude coal tar acids. Composed primarily of hydrocarbons and aromatic nitrogen bases.
310-191-5
122384-78-5
Carc. 1B; Muta. 1B
Extract residues (coal), naphthalene oil, alk., naphthalene-low; Naphthalene Oil Extract Residue [ complex combination of hydrocarbons remaining after the removal of naphthalene from alkali-washed naphthalene oil by a crystallization process. It is composed primarily of naphthalene and alkyl naphthalenes.]
A complex combination of hydrocarbons remaining after the removal of naphthalene from alkali-washed naphthalene oil by a crystallization process. It is composed primarily of naphthalene and alkyl naphthalenes.
310-167-4
121620-48-2
Carc. 1B; Muta. 1B
Extract residues (coal), naphthalene oil, alk.; Naphthalene Oil Extract Residue [ complex combination of hydrocarbons obtained from the alkali washing of naphthalene oil to remove phenolic compounds (tar acids). It is composed of naphthalene and alkyl naphthalenes.]
A complex combination of hydrocarbons obtained from the alkali washing of naphthalene oil to remove phenolic compounds (tar acids). It is composed of naphthalene and alkyl naphthalenes.
310-166-9
121620-47-1
Carc. 1B; Muta. 1B
Extracts (petroleum), light paraffinic distillate solvent, carbon-treated; Distillate aromatic extract (treated) [ complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillate treated with activated charcoal to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.]
A complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillate treated with activated charcoal to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.
309-672-2
100684-02-4
Carc. 1B
Extracts (petroleum), light paraffinic distillate solvent, clay-treated; Distillate aromatic extract (treated) [ complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillates treated with bleaching earth to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.]
A complex combination of hydrocarbons obtained as a fraction from distillation of an extract recovered by solvent extraction of light paraffinic top petroleum distillates treated with bleaching earth to remove traces of polar constituents and impurities. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C16 through C32.
309-673-8
100684-03-5
Carc. 1B
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