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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 25 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
sodium [29H,31H-phthalocyaninato-(2-)-N29,N30,N31,N32]-((3-(N-methyl-N-(2-hydroxyethyl)amino)propyl)amino)sulfonyl-sulfonato, copper complex
DIRECT BLUE CA 36133
412-730-0
150522-10-4
Skin Corr. 1B
sodium and potassium 4-(3-aminopropylamino)-2,6-bis[3(4-methoxy-2-sulfophenylazo)4-hydroxy-2-sulfo-7-naphthylamino]-1,3,5-triazine
RED ULK 1324
416-280-6
156769-97-0
Skin Sens. 1
sodium azide
247-852-1
26628-22-8
Acute Tox. 2
sodium benzoyloxybenzene-4-sulfonate
LU20
405-450-5
66531-87-1
Skin Sens. 1
sodium bifluoride; sodium hydrogen difluoride
215-608-3
1333-83-1
Acute Tox. 3; Skin Corr. 1B
sodium carbonate
207-838-8
497-19-8
Eye Irrit. 2
sodium chlorate
231-887-4
7775-09-9
Ox. Sol. 1; Acute Tox. 4
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 cyanate
213-030-6
917-61-3
Acute Tox. 4
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 dithionite; sodium hydrosulphite
231-890-0
7775-14-6
Self-heat. 1; Acute Tox. 4
sodium ethanolate; sodium ethoxide
205-487-5
141-52-6
Self-heat. 1; Skin Corr. 1B
sodium fluoride
231-667-8
7681-49-4
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
sodium fluoroacetate
200-548-2
62-74-8
Acute Tox. 2; Acute Tox. 1
sodium hydride
231-587-3
7646-69-7
Water-react. 1
sodium hydrogensulphate
231-665-7
7681-38-1
Eye Dam. 1
sodium hydrogensulphite ... %; sodium bisulphite . . . %
231-548-0
7631-90-5
Acute Tox. 4
sodium hydroxide; caustic soda
215-185-5
1310-73-2
Skin Corr. 1A
sodium hypochlorite, solution... % Cl active
231-668-3
7681-52-9
Skin Corr. 1B; Eye Dam. 1
sodium metabisulphite
231-673-0
7681-57-4
Acute Tox. 4; Eye Dam. 1
sodium methanolate; sodium methoxide
204-699-5
124-41-4
Self-heat. 1; Skin Corr. 1B
sodium methyl [(4-aminophenyl)sulphonyl]carbamate; sodium methyl (EZ)-sulfanilylcarbonimidate; asulam-sodium
218-953-8
2302-17-2
Skin Sens. 1
sodium N-(hydroxymethyl)glycinate; [formaldehyde released from sodium N-(hydroxymethyl)glycinate]
274-357-8
70161-44-3
Carc. 1B; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2; Skin Sens. 1
sodium nitrite
231-555-9
7632-00-0
Ox. Sol. 3; Acute Tox. 3
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 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
Ox. Sol. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
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
Ox. Sol. 2; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
sodium perchlorate
231-511-9
7601-89-0
Ox. Sol. 1; Acute Tox. 4
sodium peroxide
215-209-4
1313-60-6
Ox. Sol. 1; Skin Corr. 1A
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
Ox. Sol. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
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
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
Ox. Sol. 2; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
sodium polysulphides
215-686-9
1344-08-7
Acute Tox. 3; Skin Corr. 1B
sodium salt of 4-amino-3,6-bis[[5-[[4-chloro-6-[(2-methyl-4-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulfophenyl]azo]-5-hydroxy-2,7-naphthalenedisulfonic acid
435-350-7
141250-43-3
Eye Dam. 1
sodium salt of chloroacetic acid; sodium chloroacetate
223-498-3
3926-62-3
Acute Tox. 3; Skin Irrit. 2
sodium salt of DNOC; sodium 4,6-dinitro-o-cresolate
219-007-7
2312-76-7
Acute Tox. 3; STOT RE 2
sodium selenite
233-267-9
10102-18-8
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
sodium, potassium, lithium 5-amino-3,6-bis(5-(4-chloro-6-(methyl-(2-methylaminoacetyl)amino)-1,3,5-triazin-2-ylamino)-2-sulfonatophenylazo)-4-hydroxynaphthalene-2,7-disulfonate
430-090-0
205764-96-1
Eye Dam. 1; Skin Sens. 1
sodiumpentachlorophenolate
205-025-2
131-52-2
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Solvent naphtha (coal), coumarone-styrene contg.; Light Oil Redistillate, intermediate boiling
287-500-4
85536-19-2
Carc. 1B; Muta. 1B
Solvent naphtha (coal), light; Light Oil Redistillate, low boiling
287-498-5
85536-17-0
Carc. 1B; Muta. 1B
Solvent naphtha (coal), xylene-styrene cut; Light Oil Redistillate, intermediate boiling
287-502-5
85536-20-5
Carc. 1B; Muta. 1B
Solvent naphtha (coal); Light Oil Extract Residues, high boiling [The distillate from either high temperature coal tar, coke oven light oil, or coal tar oil alkaline extract residue having an approximate distillation range of 130o C to 210o C (266oF to 410oF). Composed primarily of indene and other polycyclic ring systems containing a single aromatic ring. May contain phenolic compounds and aromatic nitrogen bases.]
The distillate from either high temperature coal tar, coke oven light oil, or coal tar oil alkaline extract residue having an approximate distillation range of 130°C to 210°C (266°F to 410°F) Composed primarily of indene and other polycyclic ring systems containing a single aromatic ring. May contain phenolic compounds and aromatic nitrogen bases.
266-013-0
65996-79-4
Carc. 1B; Muta. 1B
Solvent naphtha (petroleum) heavy aliph.; Straight run kerosine [A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C11 through C16 and boiling in the range of approximately 190 °C to 290 °C (374 °F to 554 °F).]
A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C11 through C16 and boiling in the range of approximately 190°C to 290°C (374°F to 554°F).
265-200-4
64742-96-7
Asp. Tox. 1
Solvent naphtha (petroleum), heavy arom.; Kerosine — unspecified [ complex combination of hydrocarbons obtained from distillation of aromatic streams. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 165 °C to 290 °C (330 °F to 554 °F).]
A complex combination of hydrocarbons obtained from distillation of aromatic streams. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 165°C to 290°C (330°F to 554°F).
265-198-5
64742-94-5
Asp. Tox. 1
Solvent naphtha (petroleum), hydrocracked heavy arom.; Cracked kerosine [ complex combination of hydrocarbons obtained by the distillation of hydrocracked petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 235 °C to 290 °C (455 °F to 554 °F).]
A complex combination of hydrocarbons obtained by the distillation of hydrocracked petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 235°C to 290°C (455°F to 554°F).
309-881-9
101316-80-7
Asp. Tox. 1
Solvent naphtha (petroleum), hydrodesulfurized heavy arom.; Kerosine — unspecified [ complex combination of hydrocarbons obtained by the catalytic hydrodesulfurization of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C13 and boiling in the range of approximately 180 °C to 240 °C (356 °F to 464 °F).]
A complex combination of hydrocarbons obtained by the catalytic hydrodesulfurization of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C13 and boiling in the range of approximately 180°C to 240°C (356°F to 464°F).
309-882-4
101316-81-8
Asp. Tox. 1
Solvent naphtha (petroleum), hydrodesulfurized medium; Kerosine — unspecified [ complex combination of hydrocarbons obtained by the catalytic hydrodesulfurization of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C13 and boiling in the range of approximately 175 °C to 220 °C (347 °F to 428 °F).]
A complex combination of hydrocarbons obtained by the catalytic hydrodesulfurization of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C13 and boiling in the range of approximately 175°C to 220°C (347°F to 428°F).
309-884-5
101316-82-9
Asp. Tox. 1
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