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 07 listopada 2024. Database contains 4918 unique substances/entries.
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A complex combination of hydrocarbons produced by the distillation of products from a catalytic fractionation process. It contains predominantly ethane, ethylene, propane, and propylene.
270-751-9
68477-70-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons obtained from the distillation of the butane stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C3 through C4.
270-750-3
68477-69-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons obtained by distillation of a blend oil. It consists primarily of hydrogen and nitrogen with various small amounts of carbon monoxide, carbon dioxide, and aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
270-749-8
68477-68-9
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons obtained by recycling the gases of the benzene unit. It consists primarily of hydrogen with various small amounts of carbon monoxide and hydrocarbons having carbon numbers in the range of C1 through C6.
270-748-2
68477-67-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
Off gases produced by the benzene unit. It consists primarily of hydrogen. Carbon monoxide and hydrocarbons having carbon numbers predominantly in the range of C1 through C6, including benzene, may also be present.
270-747-7
68477-66-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
The feed gas to the amine system for removal of hydrogen sulfide. It consists of hydrogen. Carbon monoxide, carbon dioxide, hydrogen sulfide and aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5 may also be present.
270-746-1
68477-65-6
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of organic compounds produced by cold acid unit extraction of saturated and unsaturated aliphatic hydrocarbons usually ranging in carbon numbers from C3 through C6, predominantly pentanes and amylenes. It consists predominantly of saturated and unsaturated hydrocarbons having carbon numbers in the range of C4 through C6, predominantly C5.
270-741-4
68477-61-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
270-738-8
68477-55-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of organic compounds obtained by the distillation of products from a steam cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C8 through C12.
270-737-2
68477-54-3
Asp. Tox. 1
Details
A complex combination of organic compounds obtained by the distillation of products from a steam cracking process. It consists of unsaturated hydrocarbons having carbon numbers predominantly in the range of C5 through C12.
270-736-7
68477-53-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained from the distillation of polymerized steam-cracked petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C12.
270-735-1
68477-50-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by distilling cracked stripped steam-cracked distillates. It consists predominantly of aromatic hydrocarbons having carbon numbers in the range of C10 through C12.
270-729-9
68477-40-7
Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by distilling cracked stripped steam-cracked distillates. It consists of hydrocarbons having carbon numbers in the range of C8 through C10 and boiling in the range of approximately 129°C to 194°C (264°F to 382°F).
270-728-3
68477-39-4
Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by distilling cracked steam cracked distillate and/or its fractionation products. It consists of hydrocarbons having carbon number predominantly in the range of C10 to low molecular weight polymers.
270-727-8
68477-38-3
Carc. 1B
Details
A complex combination of hydrocarbons from the distillation of saturated and unsaturated aliphatic hydrocarbons usually ranging in the carbon numbers C3 through C6. It consists of saturated and unsaturated hydrocarbons having carbon numbers in the range of C3 through C6, predominantly piperylenes.
270-726-2
68477-35-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons from the distillation of hydrocarbons usually ranging in carbon numbers from C3 through C5, predominantly isopentane and 3-methyl-1-butene. It consists of saturated and unsaturated hydrocarbons having carbon numbers in the range of C3 through C5, predominantly 2-methyl-2-butene.
270-725-7
68477-34-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons from the distillation of saturated and unsaturated hydrocarbons usually ranging in carbon numbers from C3 through C6, predominantly butane and isobutane. It consists of saturated and unsaturated hydrocarbons having carbon numbers in the range of C3 through C4, predominantly isobutane.
270-724-1
68477-33-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
The complex combination of hydrocarbons from the distillation of catalytic reformer fractionator residue. It boils approximately below 288°C (550°F).
270-722-0
68477-31-6
Carc. 1B
Details
A complex combination of hydrocarbons from the distillation of catalytic reformer fractionator residue. It boils in the range of approximately 288°C to 371°C (550°F to 700°F).
270-721-5
68477-30-5
Carc. 1B
Details
A complex combination of hydrocarbons from the distillation of catalytic reformer fractionator residue. It boils in the range of approximately 343°C to 399°C (650°F to 750°F).
270-719-4
68477-29-2
Carc. 1B
Details
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
Details
A complex combination of hydrocarbons obtained by subjecting liquefied petroleum gas mix to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C7 and boiling in the range of approximately -40°C to 80°C (-40°F to 176°F).
270-705-8
68476-86-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons produced by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C7 and boiling in the range of approximately -40°C to 80°C (-40°F to 176°F).
270-704-2
68476-85-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
270-695-5
68476-55-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
270-690-8
68476-50-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
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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