EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998

This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. It 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). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

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Last updated 14 listopada 2024. Database contains 4821 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
Petrolatum (petroleum), silicic acid-treated; Petrolatum [A complex combination of hydrocarbons obtained by the treatment of petroleum petrolatum with silicic acid for the removal of trace polar constituents and impurities. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly greater than C20.]
A complex combination of hydrocarbons obtained by the treatment of petroleum petrolatum with silicic acid for the removal of trace polar constituents and impurities. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly greater than C20.
308-150-1
97862-98-1
Carc. 1B
Petroleum gases, liquefied, sweetened, C4 fraction; Petroleum gas [A complex combination of hydrocarbons obtained by subjecting a liquified petroleum gas mix to a sweetening process to oxidize mercaptans or to remove acidic impurities. It consists predominantly of C4 saturated and unsaturated hydrocarbons.]
A complex combination of hydrocarbons obtained by subjecting a liquified petroleum gas mix to a sweetening process to oxidize mercaptans or to remove acidic impurities. It consists predominantly of C4 saturated and unsaturated hydrocarbons.
295-463-0
92045-80-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Phenol, nonyl-, branched
291-844-0
90481-04-2
yes
Phenols, C9-11; Distillate Phenols
293-435-2
91079-47-9
Carc. 1B; Muta. 1B
phosfolan (ISO); diethyl 1,3-dithiolan-2-ylidenephosphoramidate
213-423-2
947-02-4
Acute Tox. 1; Acute Tox. 2
pilocarpine
202-128-4
92-13-7
Acute Tox. 2
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, 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, 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; 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
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