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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 19 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
perfluorononan-1-oic acid
206-801-3
375-95-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
perfluorononan-1-oic acid sodium salts
-
21049-39-8
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
perfluorooctanoic acid
206-397-9
335-67-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
Phenanthrene
201-581-5
85-01-8
yes
Phenol, 4-nonyl-, phosphite (3:1)
608-492-4
3050-88-2
yes
Phenol, heptyl derivs.
276-743-1
72624-02-3
yes
Phenol, nonyl-, branched
291-844-0
90481-04-2
yes
phenolphthalein
201-004-7
77-09-8
Carc. 1B; Muta. 2; Repr. 2
yes
Pitch, coal tar, high-temp.; Pitch [The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30 °C to 180 °C (86°F to 356°F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.]
The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30°C to 180°C (86°F to 356°F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.
266-028-2
65996-93-2
Carc. 1A; Muta. 1B; Repr. 1B
yes
Polyethylene glycol mono(tert-octylph-enyl) ether9036-19-5
618-541-1
9036-19-5
yes
Potassium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionate
266-578-3
67118-55-2
yes
potassium chromate
232-140-5
7789-00-6
Carc. 1B; Muta. 1B; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
yes
potassium dichromate
231-906-6
7778-50-9
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
Potassium hydroxyoctaoxodizincatedichromate
234-329-8
11103-86-9
yes
Potassium perfluorohexane-1-sulphonate
223-393-2
3871-99-6
yes
propylene oxide; 1,2-epoxypropane; methyloxirane
200-879-2
75-56-9
Flam. Liq. 1; Carc. 1B; Muta. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
yes
Pyrene
204-927-3
129-00-0
yes
Pyrochlore, antimony lead yellow
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77588.
232-382-1
8012-00-8
yes
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 product of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and phenol, heptyl derivs.
-
-
yes
Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP)
939-460-0
1471311-26-8
yes
Salts of 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid
-
-
yes
Salts of Perfluorobutane sulfonic acid
-
-
yes
Salts of Perfluorohexane-1-sulfonic acid
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Sulfonium, bis(4-methylphenyl)phenyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 341548-85-4
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, cesium salt (1:1) EC / List no: - | CAS no: 92011-17-1
Tridecafluorohexanesulphonic acid, compound with 2,2'-iminodiethanol (1:1) EC / List no: 274-462-9 | CAS no: 70225-16-0
Iodonium, bis[(1,1-dimethylethyl)phenyl]-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid (1:1) (9CI) EC / List no: - | CAS no: 866621-50-3
Iodonium, bis[4-(1,1-dimethylpropyl)phenyl]-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic EC / List no: - | CAS no: 421555-74-0
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, lithium salt (1:1) EC / List no: - | CAS no: 55120-77-9
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, zinc salt EC / List no: - | CAS no: 70136-72-0
Sulfonium, triphenyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 144116-10-9
N,N,N-triethylethanaminium tridecafluorohexane-1-sulfonate EC / List no: - | CAS no: 108427-55-0
Ammonium perfluorohexane-1-sulphonate EC / List no: 269-511-6 | CAS no: 68259-08-5
Sulfonium, tris[4-(1,1-dimethylethyl)phenyl]-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 425670-70-8
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, gallium salt (9CI) EC / List no: - | CAS no: 341035-71-0
Sulfonium, [4-[(2-methyl-1-oxo-2-propen-1-yl)oxy]phenyl]diphenyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 911027-68-4
Methanaminium, N-[4-[[4-(dimethylamino)phenyl][4-(phenylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 1310480-28-4
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, compd.with 2-methyl-2-propanamine (1:1) EC / List no: - | CAS no: 202189-84-2
Beta-Cyclodextrin, compd. with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid ion(1-)(1:1) EC / List no: - | CAS no: 1329995-45-0
Sulfonium, (thiodi-4,1-phenylene)bis[diphenyl-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid (1:2) EC / List no: - | CAS no: 421555-73-9
Potassium perfluorohexane-1-sulphonate EC / List no: 223-393-2 | CAS no: 3871-99-6
N,N,N-tributylbutan-1-aminium tridecafluorohexane-1-sulfonate EC / List no: - | CAS no: 108427-54-9
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, compd. With pyrrolidine (1:1) EC / List no: - | CAS no: 1187817-57-7
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, yttrium(3+) salt (3:1) EC / List no: - | CAS no: 41242-12-0
Iodonium, bis[4-(1,1-dimethylethyl)phenyl]-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 213740-81-9
Phosphonium, triphenyl(phenylmethyl)-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 1000597-52-3
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, sodium salt EC / List no: - | CAS no: 82382-12-5
Quinolinium, 1-(carboxymethyl)-4-[2-[4-[4-(2,2-diphenylethenyl)phenyl]-1,2,3,3a,4,8b-hexahydrocyclopent[b]indol-7-yl]ethenyl]-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 1462414-59-0
Methanaminium, N,N,N-trimethyl-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid (1:1) EC / List no: - | CAS no: 189274-31-5
Sulfonium, [4-[(2-methyl-1-oxo-2-propenyl)oxy]phenyl]diphenyl-, salt with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid (1:1), polymer with 2-ethyltricyclo[3.3.1.13,7]dec-2-yl 2-methyl-2-propenoate, 3-hydroxytricyclo[3.3.1.13,7]dec-1-yl 2-methyl-2-propenoate and tetrahydro-2-oxo-3-furanyl 2-methyl-2-propenoate EC / List no: - | CAS no: 911027-69-5
Sulfonium, (4-methylphenyl)diphenyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 910606-39-2
Iodonium, diphenyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 153443-35-7
Dibenzo[k,n][1,4,7,10,13]tetraoxathiacyclopentadecinium, 19-[4-(1,1-dimethylethyl)phenyl]-6,7,9,10,12,13-hexahydro-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 928049-42-7
Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 1310480-24-0
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, neodymium(3+) salt (3:1) EC / List no: - | CAS no: 41184-65-0
Gamma-Cyclodextrin, compd. with 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonic acid ion(1-)(1:1) EC / List no: - | CAS no: 1329995-69-8
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, scandium(3+) salt (3:1) EC / List no: - | CAS no: 350836-93-0
1-Hexanesulfonic acid, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-, compd. with N,N-diethylethanamine (1:1) EC / List no: - | CAS no: 72033-41-1
Methanaminium, N-[4-[[4-(dimethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, 1,1,2,2,3,3,4,4,5,5,6,6,6-tridecafluoro-1-hexanesulfonate (1:1) EC / List no: - | CAS no: 1310480-27-3
-
-
yes
Silicic acid (H2Si2O5), barium salt (1:1), lead-doped
272-271-5
68784-75-8
yes
Silicic acid, lead salt
234-363-3
11120-22-2
yes
sodium chromate
231-889-5
7775-11-3
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
sodium dichromate
234-190-3
10588-01-9
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
yes
Sodium dichromate
616-541-6
7789-12-0
yes
sodium nonadecafluorodecanoate
-
3830-45-3
Carc. 2; Repr. 1B; Lact.
yes
Sodium perborate; perboric acid, sodium salt;sodium perborate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];sodium perborate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
239-172-9
15120-21-5
yes
Sodium peroxometaborate;sodium peroxometaborate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];sodium peroxometaborate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
231-556-4
7632-04-4
yes
strontium chromate
232-142-6
7789-06-2
Carc. 1B; Acute Tox. 4
yes
Sulfuric acid, cadmium salt (1:1), hydrate (3:8)
616-572-5
7790-84-3
yes
Sulfurous acid, lead salt, dibasic
263-467-1
62229-08-7
yes
Sulphuric acid, cadmium salt (1:1), unspecified hydration rate
626-360-4
15244-35-6
yes
Terphenyl, hydrogenated
262-967-7
61788-32-7
yes
Terphenyl, hydrogenated
262-967-7
61788-32-7
yes
tetraboron disodium heptaoxide, hydrate
235-541-3
12267-73-1
Repr. 1B
yes
Tetraethyllead
201-075-4
78-00-2
yes
Tetralead trioxide sulphate
235-380-9
12202-17-4
yes
trans-cyclohexane-1,2-dicarboxylic anhydride
238-009-9
14166-21-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
trichloroethylene; trichloroethene
201-167-4
79-01-6
Carc. 1B; Muta. 2; Eye Irrit. 2; Skin Irrit. 2; STOT SE 3
yes
Tricosafluorododecanoic acid
206-203-2
307-55-1
yes
Tridecafluorohexanesulphonic acid, compound with 2,2'-iminodiethanol (1:1)
274-462-9
70225-16-0
yes
triethyl arsenate
TRIETHYLARSENAT; TRIETHYLARSENATE; TRIETHYLARSENATE (TEASAT)
427-700-2
15606-95-8
Carc. 1A; Acute Tox. 3
yes
Trilead bis(carbonate)dihydroxide
215-290-6
1319-46-6
yes
Trilead diarsenate
222-979-5
3687-31-8
yes
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