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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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.

Last updated 22 May 2024. Database contains 4753 unique substances/entries.
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A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 135°C to 210°C(275°F to 410°F).
270-988-8
68512-78-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
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 C8 through C10 and boiling in the range of approximately 135°C to 210°C (275°F to 410°F).
265-199-0
64742-95-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
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 C9 through C12 and boiling in the range of approximately 140°C to 220°C (284°F to 428°F).
265-191-7
64742-88-7
STOT RE 1; Asp. Tox. 1
269-710-8
68310-42-9
Acute Tox. 2
269-439-5
68239-26-9
Acute Tox. 2
263-467-1
62229-08-7
yes
A complex combination of hydrocarbons obtained from fractionation of catalytic cracked clarified oil and thermal cracked vacuum residue. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
270-802-5
68478-21-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
The complex combination of hydrocarbons from the distillation of the products from catalytic cracked distillates and catalytic cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C1 through C4.
269-617-2
68307-98-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained by the fractionation of catalytic cracked naphtha and distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
273-170-9
68952-77-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from the stabilization of catalytic cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
270-803-0
68478-22-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from refractionation of products from a catalytic cracking process. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C3.
270-805-1
68478-25-1
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from the fractionation of products from catalytic cracking, catalytic reforming and hydrodesulfurizing processes treated to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
270-804-6
68478-24-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from the hydrodesulfurization of naphtha. It consists of hydrogen, methane, ethane, and propane.
273-173-5
68952-79-4
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons from the fractionation stabilization products from polymerization of naphtha. It consists predominantly of hydrocarbons having carbon numbers in the range of C1 through C4.
269-618-8
68307-99-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from fractionation stabilization of catalytic reformed naphtha and from which hydrogen sulfide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
269-619-3
68308-00-9
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from the fractionation stabilization of catalytic reformed naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
270-806-7
68478-26-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from the catalytic reforming of straight run naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
270-807-2
68478-27-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from the stabilization of catalytic reformed naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
270-808-8
68478-28-4
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained by treating cracked distillates with hydrogen in the presence of a catalyst. It consists of hydrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
270-809-3
68478-29-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained by treating thermal cracked distillates with hydrogen in the presence of a catalyst. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
269-620-9
68308-01-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from the distillation of products from the catalytic cracking of gas oil. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
269-623-5
68308-03-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons from the distillation of products from miscellaneous hydrocarbon streams. It consists of hydrocarbon having carbon numbers predominantly in the range of C1 through C4.
269-625-6
68308-05-4
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons from the distillation of products from miscellaneous hydrocarbon streams. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
269-624-0
68308-04-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from fractionation of hydrodesulfurized naphtha and distillate hydrocarbon streams and treated to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
269-626-1
68308-06-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from hydrodesulfurization of straight-run naphtha. It consists of hydrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
270-810-9
68478-30-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from stripping stabilization of catalytic hydrodesulfurized vacuum gas oil and from which hydrogen sulfide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
269-627-7
68308-07-6
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from the fractionation stabilization products from isomerized naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
269-628-2
68308-08-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from fractionation stabilization of light straight run naphtha and from which hydrogen sulfide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
269-629-8
68308-09-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from the distillation of the reaction products of propane with propylene. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
269-631-9
68308-11-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from the fractionation stabilization of straight-run naphtha, distillation tail gas and catalytic reformed naphtha stabilizer tail gas. It consists of hydrocarbons having carbon numbers in the range of C3 through C6, predominantly butane and isobutane.
270-813-5
68478-32-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from fractionation of distillate tail gas, straight-run naphtha, catalytic reformed naphtha stabilizer tail gas. It consists predominantly of hydrocarbons having carbon numbers in the range of C1 through C5, predominantly methane and ethane.
270-814-0
68478-33-1
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from catalytic hydrodesulfurization of straight run distillates and from which hydrogen sulfide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
269-630-3
68308-10-1
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination obtained from the hydrodesulfurization of straight-run naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
273-174-0
68952-80-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from the fractionation stabilization of thermal cracked hydrocarbons from petroleum coking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
273-176-1
68952-82-9
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from the separation of thermal-cracked distillates, naphtha and gas oil. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
273-175-6
68952-81-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from catalytic hydrodesulfurization of vacuum gas oil and from which hydrogen sulfide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
269-632-4
68308-12-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from the thermal cracking of vacuum residues. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
270-815-6
68478-34-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
The reaction product obtained by neutralizing coal tar oil alkaline extract with an acidic solution, such as aqueous sulfuric acid, or gaseous carbon dioxide, to obtain the free acids. Composed primarily of tar acids such as phenol, cresols, and xylenols.
266-019-3
65996-85-2
Carc. 1B; Muta. 1B
The residue from crude coal tar acids after removal of phenol, cresols, xylenols and any higher boiling phenols. A black solid with a melting point approximately 80°C (176°F). Composed primarily of polyalkylphenols, resin gums, and inorganic salts.
271-418-0
68555-24-8
Carc. 1B; Muta. 1B
272-361-4
68815-21-4
Carc. 1B; Muta. 1B
The residue from the distillation in the range of 235°C to 355°C (481°F to 697°F) of light carbolic oil.
270-713-1
68477-23-6
Carc. 1B; Muta. 1B
The reaction product obtained by neutralizing coal tar base extract oil with an alkaline solution, such as aqueous sodium hydroxide, to obtain the free bases. Composed primarily of such organic bases as acridine, phenanthridine, pyridine, quinoline and their alkyl derivatives.
266-018-8
65996-84-1
Carc. 1B; Muta. 1B
271-020-7
68513-87-1
Carc. 1B; Muta. 1B
The distillate from high temperature coal tar having an approximate distillation range of 130°C to 250°C (266°F to 410°F). Composed primarily of naphthalene, alkylnaphthalenes, phenolic compounds, and aromatic nitrogen bases.
266-016-7
65996-82-9
Carc. 1B; Muta. 1B
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. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons with a high solid content of coal- and coke-type materials.
273-615-7
68990-61-4
Carc. 1B
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
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
211-479-2
650-51-1
STOT SE 3
262-967-7
61788-32-7
yes
262-967-7
61788-32-7
yes

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