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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 24 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
potassium ethanolate; potassium ethoxide
213-029-0
917-58-8
Self-heat. 1; Skin Corr. 1B
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 cyanate
209-676-3
590-28-3
Acute Tox. 4
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 chlorate
223-289-7
3811-04-9
Ox. Sol. 1; Acute Tox. 4
potassium bromate
231-829-8
7758-01-2
Ox. Sol. 1; Carc. 1B; Acute Tox. 3
potassium bis(N-carboxymethyl)-N-methyl-glycinato-(2-)N, O,O, N)-ferrate-(1-)monohydrate
CHEMICAL CHELATING AGENT #2
411-640-9
153352-59-1
Acute Tox. 4
potassium bifluoride; potassium hydrogen difluoride
232-156-2
7789-29-9
Acute Tox. 3; Skin Corr. 1B
potassium 4-iodo-2-sulfonato-benzoic acid
426-620-5
619297-89-1
Eye Dam. 1
potassium 4-(11-methacrylamidoundecanamido)benzenesulfonate
V67282
406-500-9
174393-75-0
Skin Sens. 1
potassium 3-iodo-6-methylbenzenesulfonate
426-300-5
-
Eye Dam. 1
potassium 3,6-dichloro-o-anisate
233-002-7
10007-85-9
Eye Irrit. 2
potassium 2-hydroxycarbazole-1-carboxylate
AZYLACID-POTASSIUMSALT
401-630-2
96566-70-0
Acute Tox. 4; Eye Irrit. 2; STOT SE 3
potassium 2-chloro-3-(benzyloxy)propionate
KLOBENPROP
426-350-8
138666-92-9
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
potassium 2-amino-2-methylpropionate octahydrate
FLEXSORB HP SOLID; MALINE K
405-560-3
120447-91-8
Acute Tox. 4; Skin Corr. 1A
potassium 2-(2,4-dichlorophenoxy)-(R)-propionate
DUPLOSAN-DP-KALIUM
413-580-9
113963-87-4
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
potassium 2,5-dichlorobenzoate
POTASSIUM 2,5-DICHLOROBENZOATE
415-700-5
184637-62-5
Acute Tox. 4; Eye Dam. 1
Potassium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionate
266-578-3
67118-55-2
yes
potassium 1-methyl-3-morpholinocarbonyl-4-[3-(1-methyl-3-morpholinocarbonyl-5-oxo-2-pyrazolin-4-ylidene)-1-propenyl]pyrazole-5-olate [containing < 0,5 % N, N-dimethylformamide (EC no; 200-679-5)];potassium 1-methyl-3-morpholinocarbonyl-4-[3-(1-methyl-3-morpholinocarbonyl-5-oxo-2-pyrazolin-4-ylidene)-1-propenyl]pyrazole-5-olate [containing ≥ 0,5 % N, N-dimethylformamide (EC No 200-679-5)]
418-260-2
183196-57-8
Skin Sens. 1
potassium 1-methyl-3-morpholinocarbonyl-4-[3-(1-methyl-3-morpholinocarbonyl-5-oxo-2-pyrazolin-4-ylidene)-1-propenyl]pyrazole-5-olate [containing < 0,5 % N, N-dimethylformamide (EC no; 200-679-5)];potassium 1-methyl-3-morpholinocarbonyl-4-[3-(1-methyl-3-morpholinocarbonyl-5-oxo-2-pyrazolin-4-ylidene)-1-propenyl]pyrazole-5-olate [containing ≥ 0,5 % N, N-dimethylformamide (EC No 200-679-5)]
418-260-2
183196-57-8
Repr. 1B; Skin Sens. 1
potassium (oxido-NNO-azoxy)cyclohexane; cyclohexylhydroxydiazene 1-oxide, potassium salt; [K-HDO]
613-953-8
66603-10-9
Flam. Sol. 1; Acute Tox. 3; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
potassium (E,E)-hexa-2,4- dienoate
246-376-1
24634-61-5
Eye Irrit. 2
potassium
231-119-8
7440-09-7
Water-react. 1; Skin Corr. 1B
potasan; O, O-diethyl O-(4-methylcoumarin-7-yl) phosphorothioate
-
299-45-6
Acute Tox. 2; Acute Tox. 1
Porphyromonas spp.
-
-
B Bacteria and similar species
polymeric reaction product of bicyclo[2.2.1]hepta-2,5-diene, ethene, 1,4-hexadiene, 1-propene with N, N-di-2-propenylformamide
X4060
404-035-6
1379801-27-0
Skin Sens. 1
polymer of allylamine hydrochloride
PAA HCL; PAA HCL 10L; PAA HCL 10S; PAA HCL 3L; PAA HCL 3S; PAA HCL H; PAA HCL L
415-050-2
71550-12-4
Acute Tox. 4; Skin Sens. 1
polyhexamethylene biguanide hydrochloride; PHMB
608-723-9
32289-58-0
Carc. 2; Acute Tox. 2; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1B
polyhexamethylene biguanide hydrochloride; PHMB
608-042-7
27083-27-8
Carc. 2; Acute Tox. 2; Acute Tox. 4; STOT RE 1; Eye Dam. 1; Skin Sens. 1B
Polyethylene glycol mono(tert-octylph-enyl) ether9036-19-5
618-541-1
9036-19-5
yes
polychlorobiphenyls; PCB
215-648-1
1336-36-3
STOT RE 2
poly-[((4-((4-ethyl-ethylene)amino)phenyl)-((4-(ethyl-(2-oxyethylene)amino)phenyl)methinyl)cyclohexa-2,5-dienylidene)-N-ethyl-N-(2-hydroxyethyl)ammonium acetate]
427-280-0
176429-27-9
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
poly-[((4-((4-(ethyl-ethylene)amino)phenyl)-(4-(ethyl-(2-oxyethylene)amino)phenyl)methinyl)-3-methylcyclohexa-2,5-dienylidene)-N-ethyl-N-(2-hydroxyethyl)ammonium acetate]
427-480-8
176429-22-4
STOT SE 3; Skin Irrit. 2; Eye Dam. 1
poly-(methyl methacrylate)-co-(butylmethacrylate)-co-(4-acryloxybutyl-isopropenyl-α, α-dimethylbenzyl carbamate)-co-(maleicanhydride)
RX-33
419-590-1
-
Flam. Sol. 1; Skin Sens. 1
poly(oxypropylenecarbonyl-co-oxy(ethylethylene)carbonyl), containing 27 % hydroxyvalerate
BIOPOL HX
403-300-3
127536-43-0
Skin Sens. 1
poly(oxo(2-butoxyethyl-3-oxobutanoato-O'1,O'3)aluminium)
AOC 2050X
403-430-0
138360-92-6
Eye Dam. 1
Polioviruses
-
-
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.
Plesiomonas shigelloides
-
-
B Bacteria and similar species
platinum(IV) nitrate/nitric acid solution
432-400-1
10102-09-7
Skin Corr. 1A
Plasmodium spp. (human and simian)
-
-
P Parasites
Plasmodium falciparum
-
-
P Parasites
Pitch; Pitch
263-072-4
61789-60-4
Carc. 1B
Pitch, coal tar-petroleum; Pitch Residues [The residue from the distillation of a mixture of coal tar and aromatic petroleum streams. A solid with a softening point from 40°C to 180°C (140°F to 356°F). Composed; primarily of a complex combination of three or more membered condensed ring aromatic hydrocarbons.]
The residue from the distillation of a mixture of coal tar and aromatic petroleum streams. A solid with a softening point from 40°C to 180°C (104°F to 356°F). Composed primarily of a complex combination of three or more membered condensed ring aromatic hydrocarbons.
269-109-0
68187-57-5
Carc. 1B
Pitch, coal tar, low-temp; Pitch Residue [A complex black solid or semi-solid obtained from the distillation of a low temperature coal tar. It has a softening point within the approximate range of 40 °C to 180 °C (104°F to 356 °F). Composed primarily of a complex mixture of hydrocarbons.]
A complex black solid or semi-solid obtained from the distillation of a low temperature coal tar. It has a softening point within the approximate range of 40°C to 180°C (104°F to 356°F). Composed primarily of a complex mixture of hydrocarbons.
292-651-4
90669-57-1
Carc. 1B
Pitch, coal tar, low-temp., oxidized; Pitch Residue, oxidised [The product obtained by air-blowing, at elevated temperature, low-temperature coal tar pitch. It has a softening-point within the approximate range of 70 °C to 180 °C (158 °F to 356 °F). Composed primarily of a complex mixture of hydrocarbons.]
The product obtained by air-blowing, at elevated temperature, low-temperature coal tar pitch. It has a softening-point within the approximate range of 70°C to 180°C (158°F to 356°F). Composed primarily of a complex mixture of hydrocarbons.
292-654-0
90669-59-3
Carc. 1B
Pitch, coal tar, low-temp., heat-treated; Pitch Residue, oxidised; Pitch Residue, heat-treated [A complex black solid obtained by the heat treatment of low temperature coal tar pitch. It has a softening point within the approximate range of 50 °C to 140 °C (122°F to 284°F). Composed primarily of a complex mixture of aromatic compounds.]
A complex black solid obtained by the heat treatment of low temperature coal tar pitch. It has a softening point within the approximate range of 50°C to 140°C (122°F to 284°F). Composed primarily of a complex mixture of aromatic compounds.
292-653-5
90669-58-2
Carc. 1B
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
Pitch, coal tar, high-temp., secondary; Pitch Redistillate [The residue obtained during the distillation of high boiling fractions from bituminous coal high temperature tar and/or pitch coke oil, with a softening point of 140 °C to 170 °C (284 °F to 392 °F) according to DIN 52025. Composed primarily of tri-and polynuclear aromatic compounds which also contain heteroatoms.]
The residue obtained during the distillation of high boiling fractions from bituminous coal high temperature tar and/or pitch coke oil, with a softening point of 140° to 170°C (284°F to 392°F) according to DIN 52025. Composed primarily of tri- and polynuclear aromatic compounds which also contain heteroatoms.
302-650-3
94114-13-3
Carc. 1B
Pitch, coal tar, high-temp., heat-treated; Pitch [The heat treated residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 80°C to180 °C (176 °F to 356 °F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.]
The heat treated residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 80°C to 180°C (176°F to 356°F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.
310-162-7
121575-60-8
Carc. 1B
pirimiphos-methyl (ISO); O-(2-diethylamino-6-methylpyrimidin-4-yl) O, O-dimethyl phosphorothioate
249-528-5
29232-93-7
Acute Tox. 4; STOT RE 1
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