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 24 svibnja 2024. Database contains 4917 unique substances/entries.
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244-437-7
21548-32-3
Acute Tox. 1; Acute Tox. 2
Details
223-404-0
3878-19-1
Carc. 2; Acute Tox. 4; STOT RE 2; Skin Sens. 1
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 obtained by the distillation of crude petroleum. It consists predominantly of aliphatic, aromatic and cycloaliphatic hydrocarbons having carbon numbers predominantly higher than C25 and boiling above approximately 400°C (752°F).
295-396-7
92045-14-2
Carc. 1B
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 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 900 SUS at 37.7°C (100°F) to a maximum of 9000 SUS at 37.7°C (100°F).
271-384-7
68553-00-4
Carc. 1B
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 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
A complex combination of hydrocarbons produced by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C9 through C20 and boiling in the range of approximately 163°C to 357°C (325°F to 675°F).
269-822-7
68334-30-5
Carc. 2
Details
203-743-0
110-17-8
Eye Irrit. 2
Details
260-875-1
57646-30-7
Acute Tox. 4
Details
203-727-3
110-00-9
Flam. Liq. 1; Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2; Skin Irrit. 2
C Carcinogenic (article 57a)
Details
265-974-3
65907-30-4
Acute Tox. 2; Acute Tox. 3; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
202-626-1
98-00-0
Carc. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3
Details
262-302-0
60568-05-0
Carc. 2
Details
215-114-8
1303-00-0
Repr. 1B; Carc. 1B; STOT RE 1
Details
A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C13 through C25 and boiling in the range of approximately 230°C to 400°C (446°F to 752°F).
265-112-6
64742-12-7
Carc. 1B
Details
A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C13 through C25 and boiling in the range of approximately 230°C to 400°C (446°F to 752°F).
265-129-9
64742-29-6
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C35 and boiling in the range of approximately 121°C to 510°C (250°F to 950°F).
272-184-2
68783-08-4
Carc. 1B
Details
A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and boiling in the range of approximately 350°C to 600°C (662°F to 1112°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-058-3
64741-57-7
Carc. 1B
Details
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 in the range of C13 through C50 and boiling in the range of approximately 230°C to 600°C (446°F to 1112°F). This stream is likely to contain 5 wt. % or more of 4- to 6- membered condensed ring aromatic hydrocarbons.
265-162-9
64742-59-2
Carc. 1B
Details
A complex combination of hydrocarbons obtained by hydrodesulfurization of heavy coker distillate stocks. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range C18 to C44 and boiling in the range of approximately 304°C to 548°C (579°F to 1018° F). Likely to contain 5% or more of 4- to 6- membered condensed ring aromatic hydrocarbons.
285-555-9
85117-03-9
Carc. 1B
Details
A complex combination of hydrocarbons obtained from a catalytic hydrodesulfurization process. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and boiling in the range of approximately 350°C to 600°C (662°F to 1112°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-189-6
64742-86-5
Carc. 1B
Details
A complex combination of hydrocarbons obtained from a petroleum stock by treating with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C13 through C25 and boiling in the range of approximately 230°C to 400°C (446°F to 752°F).
265-182-8
64742-79-6
Carc. 1B
Details
A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists predominantly of aliphatic hydrocarbons having carbon numbers predominantly in the range of C11 through C25 and boiling in the range of approximately 205°C to 400°C (401°F to 752°F).
265-092-9
64741-90-8
Carc. 1B
Details
A complex combination of hydrocarbons produced by distillation of the products from a steam cracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C9 and boiling in the range of from approximately 205°C to 400°C (400°F to 752°F)
271-260-2
68527-18-4
Carc. 1B
Details
295-411-7
92045-29-9
Carc. 1B
Details
A complex combination of hydrocarbons produced by the catalytic cracking of gas oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C4.
271-737-5
68606-27-9
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
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
A complex combination produced by treating the feed from the benzene unit with hydrogen in the presence of a catalyst followed by depentanizing. It consists primarily of hydrogen, ethane and propane with various small amounts of nitrogen, carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers predominantly in the range of C1 through C6. It may contain trace amounts of benzene.
271-623-5
68602-82-4
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
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 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 produced by the distillation of crude oil and/or the cracking of tower gas oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
271-624-0
68602-83-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
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 by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of saturated and unsaturated hydrocarbons having carbon numbers predominantly in the range of C2 through C4 and boiling in the range of approximately -51°C to -34°C (-60°F to -30°F).
272-205-5
68783-65-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons obtained by the extraction of hydrogen from a gas stream which consists primarily of hydrogen with small amounts of nitrogen, carbon monoxide, methane, ethane, and ethylene. It contains predominantly hydrocarbons such as methane, ethane, and ethylene with small amounts of hydrogen, nitrogen and carbon monoxide.
270-766-0
68477-84-9
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
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
A complex combination of hydrocarbons produced by distillation of products from the cracking of crude oil. It consists of hydrocarbons having carbon numbers in the range of C3 through C4, predominantly of propane and propylene, and boiling in the range of approximately -51°C to -1°C (-60°F to 30°F.)
268-629-5
68131-75-9
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of olefinic and paraffinic hydrocarbons having carbon numbers in the range of C3 through C5 which are used as alkylation feed. Ambient temperatures normally exceed the critical temperature of these combinations.
270-765-5
68477-83-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons produced by distillation of products from a catalytic fractionation process. It consists of aliphatic hydrocarbons having carbon numbers in the range of C3 through C5, predominantly C4.
270-767-6
68477-85-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
270-763-4
68477-82-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons produced by distillation of products from catalytic reforming of C6-C8 feed and recycled to conserve hydrogen. It consists primarily of hydrogen. It may also contain various small amounts of carbon monoxide, carbon dioxide, nitrogen, and hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
270-761-3
68477-80-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons produced by distillation of products from catalytic reforming of C6-C8 feed. It consists of hydrocarbons having carbon numbers in the range of C1 through C5 and hydrogen.
270-762-9
68477-81-6
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons obtained from fractionation of catalytic cracked naphtha. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
273-169-3
68952-76-1
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons obtained from fractionation of catalytic cracked hydrocarbons and treated to remove acidic impurities. It consists of hydrocarbons having carbon numbers in the range of C2 through C4, predominantly C3.
270-755-0
68477-73-6
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details

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