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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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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Substance Name
EC No.
CAS No.
EU CLP (1272/2008)
EU_BA Directive 2000/54/EC
EU REACH: List of SVHC
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate; sodium peroxoborate hexahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate; sodium peroxoborate hexahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
yes
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate; sodium peroxoborate hexahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate; sodium peroxoborate hexahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate; sodium peroxoborate hexahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate; sodium peroxoborate hexahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate; sodium peroxoborate hexahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate; sodium peroxoborate hexahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate; sodium peroxoborate hexahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate; sodium peroxoborate hexahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate; sodium peroxoborate hexahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate; sodium peroxoborate hexahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Perboric acid, sodium salt, tetrahydrate;Sodium perborate; perboric acid, sodium salt;perboric acid, sodium salt, monohydrate;perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, monohydrate; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate; sodium peroxoborate hexahydrate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt, tetrahydrate; sodium peroxoborate hexahydrate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing < 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm];perboric acid, sodium salt; sodium peroxoborate [containing ≥ 0,1 % (w/w) of particles with an aerodynamic diameter of below 50 μm]
234-390-0
11138-47-9;12040-72-1;37244-98-7
Repr. 1B; STOT SE 3; Eye Dam. 1
perfluorooctane sulfonic acid; heptadecafluorooctane-1-sulfonic acid
217-179-8
1763-23-1
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
pethoxamide (ISO); 2-chloro-N-(2-ethoxyethyl)-N-(2-methyl-1-phenylprop-1enyl)acetamide
600-765-6
106700-29-2
Acute Tox. 4; Skin Sens. 1
Petrolatum (petroleum), clay-treated; Petrolatum [A complex combination of hydrocarbons obtained by treatment of petrolatum with bleaching earth for the removal of traces of polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of greater than C25.]
A complex combination of hydrocarbons obtained by treatment of petrolatum with bleaching earth for the removal of traces of polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of greater than C25.
309-706-6
100684-33-1
Carc. 1B
Phenanthrene, distn. residues; Heavy Anthracene Oi Redistillate [Residue from the distillation of crude phenanthrene boiling in the approximate range of 340 °C to 420 °C (644°F to 788°F). It consists predominantly of phenanthrene, anthracene and carbazole.]
Residue from the distillation of crude phenanthrene boiling in the approximate range of 340°C to 420°C (644°F to 788°F). It consists predominantly of phenanthrene, anthracene and carbazole.
310-169-5
122070-78-4
Carc. 1B
phenol, 2-dodecyl-, branched
701-105-0
1801269-80-6
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
phenol, 3-dodecyl-, branched
701-107-1
1801269-77-1
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
phenol, dodecyl-, branched
310-154-3
121158-58-5
Repr. 1B; Skin Corr. 1C; Eye Dam. 1
phenol; carbolic acid; monohydroxybenzene; phenylalcohol
203-632-7
108-95-2
Muta. 2; Acute Tox. 3; STOT RE 2; Skin Corr. 1B
phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide
CGI 819
423-340-5
162881-26-7
Skin Sens. 1A
phenyl glycidyl ether; 2,3-epoxypropyl phenyl ether;1,2-epoxy-3-phenoxypropane
204-557-2
122-60-1
Carc. 1B; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
phenylhydrazine
202-873-5
100-63-0
Carc. 1B; Muta. 2; Acute Tox. 3; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
phenylmercury hydroxide
202-866-7
100-57-2
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
phosphamidon (ISO); 2-chloro-2-diethylcarbamoyl-1-methylvinyl dimethyl phosphate
236-116-5
13171-21-6
Muta. 2; Acute Tox. 2; Acute Tox. 3
phosphonic acid
237-066-7
13598-36-2
Acute Tox. 4; Skin Corr. 1A
phosphoric acid, calcium nickel salt
-
17169-61-8
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
phosphorous acid
233-663-1
10294-56-1
Acute Tox. 4; Skin Corr. 1A
phosphorus pentachloride
233-060-3
10026-13-8
Acute Tox. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
phosphorus pentoxide
215-236-1
1314-56-3
Skin Corr. 1A
phosphoryl trichloride
233-046-7
10025-87-3
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Skin Corr. 1A
phoxim (ISO); α-(diethoxyphosphinothioylimino) phenylacetonitrile
238-887-3
14816-18-3
Repr. 2; Acute Tox. 4; Skin Sens. 1
piperazine [liquid];piperazine [solid]
203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
piperazine [liquid];piperazine [solid]
203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
piperazine dihydrochloride
205-551-2
142-64-3
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
piperazine phosphate
217-775-8
1951-97-9
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
piperidine
203-813-0
110-89-4
Flam. Liq. 2; Acute Tox. 3; Skin Corr. 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
platinum(IV) nitrate/nitric acid solution
432-400-1
10102-09-7
Skin Corr. 1A
poly(oxo(2-butoxyethyl-3-oxobutanoato-O'1,O'3)aluminium)
AOC 2050X
403-430-0
138360-92-6
Eye Dam. 1
poly(oxypropylenecarbonyl-co-oxy(ethylethylene)carbonyl), containing 27 % hydroxyvalerate
BIOPOL HX
403-300-3
127536-43-0
Skin Sens. 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-[((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
polychlorobiphenyls; PCB
215-648-1
1336-36-3
STOT RE 2
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
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 2,5-dichlorobenzoate
POTASSIUM 2,5-DICHLOROBENZOATE
415-700-5
184637-62-5
Acute Tox. 4; Eye Dam. 1
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-amino-2-methylpropionate octahydrate
FLEXSORB HP SOLID; MALINE K
405-560-3
120447-91-8
Acute Tox. 4; Skin Corr. 1A
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 3,6-dichloro-o-anisate
233-002-7
10007-85-9
Eye Irrit. 2
potassium 4-(11-methacrylamidoundecanamido)benzenesulfonate
V67282
406-500-9
174393-75-0
Skin Sens. 1
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 ferrite
430-010-4
12160-44-0
Skin Corr. 1B; Skin Sens. 1
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