EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the 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).

Last updated 11 rujna 2024. Database contains 4917 unique substances/entries.
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A complex combination of hydrocarbons obtained by distillation from prehydrogenated cracked naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C8 through C11 and boiling in the range of approximately 130°C to 205°C (266°F to 401°F).
295-444-7
92045-62-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by distillation from the product of a naphtha steam cracking process and subsequent catalytic selective hydrogenation of gum formers. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 30°C to 230°C (86°F to 446°F).
295-443-1
92045-61-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by subjecting a petroleum naphtha to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C5, predominantly C5, and boiling in the range of approximately minus 10°C to 35°C (14°F to 95°F).
295-442-6
92045-60-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by subjecting naphtha from a catalytic cracking process to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of hydrocarbons boiling in a range of approximately 35°C to 210°C (95°F to 410°F).
295-441-0
92045-59-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by distillation of a gasoline which has been catalytically isomerized. It consists predominantly of hexane isomers boiling in the range of approximately 60°C to 66°C (140°F to 151°F).
295-440-5
92045-58-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by treating a petroleum fraction, derived from a pyrolysis process, with hydrogen in the presence of a catalyst. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approximately 35°C to 190°C (95°F to 374°F).
295-438-4
92045-57-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A combination of hydrocarbons obtained from the distillation of hydrotreated naphtha followed by a solvent extraction and distillation process. It consists predominantly of saturated hydrocarbons boiling in the range of approximately 94°C to 99°C (201°F to 210°F).
295-436-3
92045-55-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by distillation of hydrodesulfurized and dearomatized light petroleum fractions. It consists predominantly of C7 paraffins and cycloparaffins boiling in a range of approximately 90°C to 100°C (194°F to 212°F).
295-434-2
92045-53-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained from a catalytic hydrodesulfurization process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately 30°C to 250°C (86°F to 482°F).
295-433-7
92045-52-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
295-432-1
92045-51-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details

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