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 12 rujna 2024. Database contains 4917 unique substances/entries.
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270-689-2
68476-49-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
270-687-1
68476-47-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by the distillations of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C11 and boiling in a range approximately up to 204°C(400°F).
270-686-6
68476-46-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
270-682-4
68476-42-6
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
270-681-9
68476-40-4
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A distillate oil having a minimum viscosity of 32.6 SUS at 37.7°C (100°F) to a maximum of 40.1 SUS at 37.7°C (100°F).
270-676-1
68476-34-6
Carc. 2
Details
The liquid product from various refinery streams, usually residues. The composition is complex and varies with the source of the crude oil.
270-675-6
68476-33-5
Carc. 1B
Details
270-674-0
68476-32-4
Carc. 1B
Details
A distillate oil having a minimum viscosity of 45 SUS at 37.7°C (100°F) to a maximum of 125 SUS at 37.7°C (100°F).
270-673-5
68476-31-3
Carc. 2
Details
A distillate oil having a minimum viscosity of 32.6 SUS at 37.7°C (100°F) to a maximum of 37.9 SUS at 37.7°C (100°F).
270-671-4
68476-30-2
Carc. 2
Details
A complex combination of light gases produced by distillation of crude oil and by catalytic reforming of naphtha. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C4 and boiling in the range of approximately -217°C to -12°C (-423°F to 10°F).
270-670-9
68476-29-9
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A combination of light gases. It consists predominantly of hydrogen and/or low molecular weight hydrocarbons.
270-667-2
68476-26-6
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons from the multiple distillation of products from a steam cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C10 through C18.
270-662-5
68475-80-9
Carc. 1B
Details
A complex combination of hydrocarbons from the distillation of products from a catalytic reforming process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C3 through C6 and boiling in the range of approximately -49°C to 63°C (-57°F to 145°F).
270-660-4
68475-79-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by the fractionation pyrolysis at 816°C (1500°F) of naphtha and raffinate. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8, including benzene.
270-658-3
68475-70-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
270-654-1
68475-60-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
270-653-6
68475-59-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
270-652-0
68475-58-1
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
270-651-5
68475-57-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
The complex combination of hydrocarbons obtained as a raffinate from a Lurgi separation unit. It consists predominantly of non-aromatic hydrocarbons with various small amounts of aromatic hydrocarbons having carbon numbers predominantly in the range of C6 through C8.
270-349-3
68425-35-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
The complex combination of hydrocarbons obtained by the pyrolysis fractionation at 816°C (1500°F) of naphtha and raffinate. It consists predominantly of hydrocarbons having a carbon number of C9 and boiling at approximately 204°C (400°F).
270-344-6
68425-29-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by distillation of the products from a heavy naphtha hydrotreating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C6 and boiling in the range of approximately -49°C to 68°C (-57°F to 155°F).
270-094-8
68410-98-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by the distillation of products from the light distillate hydrotreating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C6 through C9 and boiling in the range of approximately 3°C to 194°C (37°F to 382°F).
270-093-2
68410-97-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by the distillation of products from a middle distillate hydrotreating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C10 and boiling in the range of approximately 127°C to 188°C (262°F to 370°F).
270-092-7
68410-96-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained as the raffinate from the UDEX extraction process on the catalytic reformer stream. It consists of saturated hydrocarbons having carbon numbers predominantly in the range of C6 through C9.
270-088-5
68410-71-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details

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