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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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
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
amines, hydrogenated tallow alkyl
262-976-6
61788-45-2
Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
octadecylamine
204-695-3
124-30-1
Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
5-endo-hexyl-bicyclo[2.2.1]hept-2-ene
435-000-3
22094-83-3
Asp. Tox. 1; Skin Irrit. 2
reaction mass of:5-endo-butyl-bicyclo[2.2.1]hept-2-ene; 5-exo-butyl-bicyclo[2.2.1]hept-2-ene (80:20)
435-180-3
-
Asp. Tox. 1; Skin Irrit. 2
Distillates (petroleum), acid-treated heavy naphthenic; Unrefined or mildly refined baseoil [A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100 °F (19cSt at 40 °C). It contains relatively few normal paraffins.]
A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-117-3
64742-18-3
Carc. 1A
Distillates (petroleum), acid-treated heavy paraffinic; Unrefined or mildly refined baseoil [A complex combination of hydrocarbons btained as a raffinate from a sulfuric acid process. It consists predomi nantly of saturated hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil having a viscosity of a least 100 SUS at 100°F (19cSt at 40 °C).]
A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil having a viscosity of at least 100 SUS at 100°F (19cSt at 40°C).
265-119-4
64742-20-7
Carc. 1A
Distillates (petroleum), acid-treated light naphthenic; Unrefined or mildly refined baseoil [A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100 °F (19cSt at 40 °C). It contains relatively few normal paraffins.]
A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-118-9
64742-19-4
Carc. 1A
Distillates (petroleum), acid-treated light paraffinic; Unrefined or mildly refined baseoil [A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oi having aviscosity of less than 100 SUS at 100 °F (19cSt at 40°C).]
A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil having a viscosity of less than 100 SUS at 100°F (19cSt at 40°C).
265-121-5
64742-21-8
Carc. 1A
Distillates (petroleum), chemically neutralized heavy naphthenic; Unrefined or mildly refined baseoil [A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100 °F (19cSt at 40 °C). It contains relatively few normal paraffins.]
A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-135-1
64742-34-3
Carc. 1A
Distillates (petroleum), chemically neutralized heavy paraffinic; Unrefined or mildly refined baseoil [A complex combination of hydrocarbons obtained from a treating proces to remove acidic materials. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100 °F (19cSt at 40 °C). It contains a relatively large proportion of aliphatic hydrocarbons.]
A complex combination of hydrocarbons obtained from a treating process to remove acidic materials. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100°F (19cSt at 40°C). It contains a relatively large proportion of aliphatic hydrocarbons.
265-127-8
64742-27-4
Carc. 1A
Distillates (petroleum), chemically neutralized light naphthenic; Unrefined or mildly refined baseoil [A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS a 100 °F (19cSt at 40 °C). It contains relatively few normal paraffins.]
A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-136-7
64742-35-4
Carc. 1A
Distillates (petroleum), chemically neutralized light paraffinic; Unrefined or mildly refined baseoil [A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity less than 100 SUS at 100 °F (19cSt at 40 °C).]
A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity less than 100 SUS at 100°F (19cSt at 40°C).
265-128-3
64742-28-5
Carc. 1A
Distillates (petroleum), heavy naphthenic; Unrefined or mildly refined baseoil [A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100 °F (19cSt at 40 °C). It contains relatively few normal paraffins.]
A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-054-1
64741-53-3
Carc. 1A
Distillates (petroleum), light naphthenic; Unrefined or mildly refined baseoil [A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100 °F (19cSt at 40 °C). It contains relatively few normal paraffins.]
A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-053-6
64741-52-2
Carc. 1A
Distillates (petroleum), light paraffinic; Unrefined or mildly refined baseoil [A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100 °F (19cSt at 40 °C). It contains a relatively large proportion of saturated aliphatic hydrocarbons normally present in this distillation range of crude oil.]
A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C). It contains a relatively large proportion of saturated aliphatic hydrocarbons normally present in this distillation range of crude oil.
265-051-5
64741-50-0
Carc. 1A
Distillates(petroleum), heavy paraffinic; Unrefined ormildly refined baseoil [A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100 °F (19cSt at 40 °C). It contains a relatively large proportion of saturated aliphatic hydrocarbons.]
A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100°F (19cSt at 40°C). It contains a relatively large proportion of saturated aliphatic hydrocarbons.
265-052-0
64741-51-1
Carc. 1A
erionite
620-440-2
12510-42-8
Carc. 1A
Tar brown-coal [An oil distilled from brown-coal tar. Composed primarily of aliphatic, naphthenic and one-to three-ring aromatic hydrocarbons, their alkyl derivates, heteroaromatics and one-and two-ring phenols boiling in the range of approximately 150°C to 360 °C (302°F to 680°F).]
An oil distilled from brown-coal tar. Composed primarily of aliphatic, naphthenic and one- to three-ring aromatic hydrocarbons, their alkyl derivatives, heteroaromatics and one- and two-ring phenols boiling in the range of approximately 150°C to 360°C (302°F to 680°F).
309-885-0
101316-83-0
Carc. 1A
Tar, brown-coal, low-temp. [A tar obtained from low temperature carbonization and low temperature gasification of brown coal. Composed primarily of aliphatic, naphthenic and cyclic aromatic hydrocarbons, heteroaromatic hydrocarbons and cyclic phenols.]
A tar obtained from low temperature carbonization and low temperature gasification of brown coal. Composed primarily of aliphatic, naphthenic and cyclic aromatic hydrocarbons, heteroaromatic hydrocarbons and cyclic phenols.
309-886-6
101316-84-1
Carc. 1A
Tar, coal, high-temp.; Coal tar [The condensation product obtained by cooling, to approxi mately ambient temperature, the gas evolved in the high temperature (greater than 700 °C (1292°F)) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons. May contain minor amounts of phenolic compounds and aromatic nitrogen bases.]
The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700°C (1292°F)) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons. May contain minor amounts of phenolic compounds and aromatic nitrogen bases.
266-024-0
65996-89-6
Carc. 1A
Tar, coal, low-temp.; Coal oil [The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in low temperature (less than 700 °C (1292°F)) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of condensed ring aromatic hydrocarbons, phenolic compounds, aromatic nitrogen bases, and their alkyl derivatives.]
The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in low temperature (less than 700°C (1292°F)) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of condensed ring aromatic hydrocarbons, phenolic compounds, aromatic nitrogen bases, and their alkyl derivatives.
266-025-6
65996-90-9
Carc. 1A
Tar, coal; Coal tar [The by-product from the destructive distillation of coal. Almost black semisolid. A complex combination of aromatic hydrocarbons, phenolic compounds, nitrogen bases and thiophene.]
The by-product from the destructive distillation of coal. Almost black semisolid. A complex combination of aromatic hydrocarbons, phenolic compounds, nitrogen bases and thiophene.
232-361-7
8007-45-2
Carc. 1A
cobalt lithium nickel oxide
442-750-5
113066-89-0
Carc. 1A; Acute Tox. 2; STOT RE 1; Skin Sens. 1
diarsenic trioxide; arsenic trioxide
215-481-4
1327-53-3
Carc. 1A; Acute Tox. 2; Skin Corr. 1B
yes
arsenic acid and it salts with the exception of those specified elsewhere in this Annex
-
-
Carc. 1A; Acute Tox. 3
arsenic acid and it salts with the exception of those specified elsewhere in this Annex
231-901-9
7778-39-4
Carc. 1A; Acute Tox. 3
yes
diarsenic pentaoxide; arsenic pentoxide; arsenic oxide
215-116-9
1303-28-2
Carc. 1A; Acute Tox. 3
yes
triethyl arsenate
TRIETHYLARSENAT; TRIETHYLARSENATE; TRIETHYLARSENATE (TEASAT)
427-700-2
15606-95-8
Carc. 1A; Acute Tox. 3
yes
2-naphthylamine
202-080-4
91-59-8
Carc. 1A; Acute Tox. 4
benzidine; 1,1'-biphenyl-4,4'-diamine; 4,4'-diaminobiphenyl; biphenyl-4,4'-ylenediamine
202-199-1
92-87-5
Carc. 1A; Acute Tox. 4
biphenyl-4-ylamine; xenylamine; 4-aminobiphenyl
202-177-1
92-67-1
Carc. 1A; Acute Tox. 4
yes
salts of 2-naphthylamine
209-030-0
553-00-4
Carc. 1A; Acute Tox. 4
salts of 2-naphthylamine
210-313-6
612-52-2
Carc. 1A; Acute Tox. 4
salts of benzidine
208-520-1
531-86-2
Carc. 1A; Acute Tox. 4
salts of benzidine
208-519-6
531-85-1
Carc. 1A; Acute Tox. 4
salts of benzidine
252-984-8
36341-27-2
Carc. 1A; Acute Tox. 4
salts of benzidine
244-236-4
21136-70-9
Carc. 1A; Acute Tox. 4
salts of biphenyl-4-ylamine; salts of xenylamine; salts of 4-aminobiphenyl
-
-
Carc. 1A; Acute Tox. 4
zinc chromates including zinc potassium chromate
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C.I. Pigment Yellow 36 EC / List no: 609-398-6 | CAS no: 37300-23-5
Zinc dichromate EC / List no: 237-843-0 | CAS no: 14018-95-2
Zinc chromate EC / List no: 236-878-9 | CAS no: 13530-65-9
Chromic acid, potassium zinc salt EC / List no: 255-252-6 | CAS no: 41189-36-0
Pentazinc chromate octahydroxide EC / List no: 256-418-0 | CAS no: 49663-84-5
Potassium hydroxyoctaoxodizincatedichromate(1-) EC / List no: 234-329-8 | CAS no: 11103-86-9
-
-
Carc. 1A; Acute Tox. 4; Skin Sens. 1
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
slimes and sludges, copper electrolyte refining, decopperised
Substance obtained as a powdery cathodic precipitate during the electrolytic decoppering stage of copper refining electrolysis. Consists primarily of copper with antimony, arsenic, lead and nickel in metallic form as well as oxides and sulfates.
305-433-1
94551-87-8
Carc. 1A; Muta. 2; Repr. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
nickel dichloride
231-743-0
7718-54-9
Carc. 1A; Muta. 2; Repr. 1B; Acute Tox. 3; STOT RE 1; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
nickel bis(sulfamidate); nickel sulfamate
237-396-1
13770-89-3
Carc. 1A; Muta. 2; Repr. 1B; Acute Tox. 4; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
diammonium nickel bis(sulfate)
239-793-5
15699-18-0
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
nickel acetate
239-086-1
14998-37-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
nickel di(acetate)
206-761-7
373-02-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
nickel dipotassium bis(sulfate)
237-563-9
13842-46-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Resp. Sens. 1; Skin Sens. 1
[carbonato(2-)] tetrahydroxytrinickel
235-715-9
12607-70-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
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