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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 02 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
Residues (petroleum), alkylation splitter, C4-rich; Petroleum gas [ complex residuum from the distillation of streams various refinery operations. It consists of hydrocarbons having carbon numbers in the range of C4 through C5, predominantly butane and boiling in the range of approximately - 11.7 o C to 27.8 o C (11 °F to 82 °F).]
A complex residuum from the distillation of streams from various refinery operations. It consists of hydrocarbons having carbon numbers in the range of C4 through C5, predominantly butane and boiling in the range of approximately -11.7°C to 27.8°C (11°F to 82°F).
271-010-2
68513-66-6
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Residues (coal), liq. solvent extn. [A cohesive powder composed of coal mineral matter and undissolved coal remaining after extraction of coal by a liquid solvent.]
A cohesive powder composed of coal mineral matter and undissolved coal remaining after extraction of coal by a liquid solvent.
302-681-2
94114-46-2
Carc. 1B
Residues (coal tar), pitch distn.; Pitch Redistillate [Residue from the fractional distillation of pitch distillate boiling in the range of approximately 400°C to 470°C (752 °F to 846 °F). Composed primarily of polynuclear aromatic hydrocarbons, and heterocyclic compounds.]
Residue from the fractional distillation of pitch distillate boiling in the range of approximately 400°C to 470°C (752°F to 846°F). Composed primarily of polynuclear aromatic hydrocarbons, and heterocyclic compounds.
295-507-9
92061-94-4
Carc. 1B
Residues (coal tar), creosote oil distn.; Wash Oil Redistillate [The residue from the fractional distillation of wash oil boiling in the approximate range of 270 o C to 330 o C (518 °F to 626 °F). It consists predomi nantly of dinuclear aromatic and heterocyclic hydrocarbons.]
The residue from the fractional distillation of wash oil boiling in the approximate range of 270°C to 330°C (518°F to 626°F). It consists predominantly of dinuclear aromatic and heterocyclic hydrocarbons.
295-506-3
92061-93-3
Carc. 1B
Residues (coal tar), anthracene oil distn.; Anthracene Oil Fraction [he residue from the fraction distillation of crude anthracene boiling in the approximate range of 340 °C to 400 °C (644°F to 752°F). It consists predominantly of tri-and polynuclear aromatic and heterocyclic hydrocarbons.]
The residue from the fraction distillation of crude anthracene boiling in the approximate range of 340°C to 400°C (644°F to 752°F). It consists predominantly of tri- and polynuclear aromatic and heterocyclic hydrocarbons.
295-505-8
92061-92-2
Carc. 1B; Muta. 1B
Residual oils (petroleum,) solvent-refined; Baseoil — unspecified [ complex combination by hydrocarbons obtained as the solvent insoluble fraction from solvent refining of a residuum using a polar organic solvent such as phenol or furfural. It consists of hydrocarbons having carbon numbers predominantly higher than C25 and boiling above approximately 400°C (752°F).]
A complex combination of hydrocarbons obtained as the solvent insoluble fraction from solvent refining of a residuum using a polar organic solvent such as phenol or furfural. It consists of hydrocarbons having carbon numbers predominantly higher than C25 and boiling above approximately 400°C (752°F).
265-101-6
64742-01-4
Carc. 1B
Residual oils (petroleum); Heavy Fuel oil [A complex combination of hydrocarbons, sulfur compounds and metal-containing organic compounds obtained as the residue from refinery fractionation cracking processes. It produces a finished oil with a viscosity above 2cSt. at 100 °C.]
A complex combination of hydrocarbons, sulfur compounds and metal-containing organic compounds obtained as the residue from refinery fractionation cracking processes. It produces a finished oil with a viscosity above 2cSt. at 100°C.
298-754-0
93821-66-0
Carc. 1B
Residual oils (petroleum), solvent-dewaxed; Baseoil — unspecified [ complex combination of hydrocarbons obtained by removal of ong, branched chain hydrocarbons from a residual oil by solvent crystalli zation. It consists of hydrocarbons having carbon numbers predominantly greater than C25 and boiling above approxi mately 400 °C (752 °F).]
A complex combination of hydrocarbons obtained by removal of long, branched chain hydrocarbons from a residual oil by solvent crystallization. It consists of hydrocarbons having carbon numbers predominantly greater than C25 and boiling above approximately 400°C (752°F).
265-166-0
64742-62-7
Carc. 1B
Residual oils (petroleum), solvent deasphalted; Baseoil — unspecified [ complex combination of hydrocarbons obtained as the solvent soluble fraction from C3-C4 solvent deasphalting of a residuum. It consists of hydrocarbons having carbon numbers predominantly higher than C25 and boiling above approximately 400 °C (752 °F).]
A complex combination of hydrocarbons obtained as the solvent soluble fraction from C3 - C4 solvent deasphalting of a residuum. It consists of hydrocarbons having carbon numbers predominantly higher than C25 and boiling above approximately 400°C (752°F).
265-096-0
64741-95-3
Carc. 1B
Residual oils (petroleum), hydrotreated; Baseoil — unspecified [ complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly greater than C25 and boiling above approximately 400 °C (752 °F).]
A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly greater than C25 and boiling above approximately 400°C (752°F).
265-160-8
64742-57-0
Carc. 1B
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