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 13 rujna 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

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