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 17 svibnja 2024. Database contains 4917 unique substances/entries.
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297-857-8
93763-38-3
Carc. 1B
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
202-613-0
97-86-9
Flam. Liq. 3; STOT SE 3; Skin Irrit. 2; Skin Sens. 1B
Details
202-590-7
97-54-1
Skin Sens. 1A
Details
307-033-2
97488-94-3
Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained from a petroleum stock by solvent refining and sweetening and boiling in the range of approximately 150°C to 260°C (302°F to 500°F).
295-416-4
92045-36-8
Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained as a wide cut hydrocarbon fuel cut from atmospheric distillation and boiling in the range of approximately 70°C to 220°C (158°F to 428°F).
295-418-5
92045-37-9
Asp. Tox. 1
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 hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of 130°C to 290°C (266°F to 554°F).
294-799-5
91770-15-9
Asp. Tox. 1
Details
LAMBDA-CYHALOTHRIN
415-130-7
91465-08-6
Acute Tox. 2; Acute Tox. 3; Acute Tox. 4
Details
The volatile organic liquid condensed from the gas evolved in the low-temperature (less than 700°C (1292°F)) destructive distillation of coal. Composed primarily of C6-10 hydrocarbons.
292-635-7
90641-11-5
Carc. 1B; Muta. 1B
Details
BIS TRIFLUOROMETHANE SULFONIMIDE LITHIUM; FLUORAD BRAND LITHIUM TRIFLUOROMETHANESULPHONIMIDE HQ-115
415-300-0
90076-65-6
Acute Tox. 3; STOT RE 2; Skin Corr. 1B
Details
A complex combination of hydrocarbons obtained by refining of crude oil. It consists predominantly of aromatics, naphthenics and paraffinics and produces a finished oil with a viscosity of 120 SUS at 100°F (23cSt at 40°C).
297-474-6
93572-43-1
Carc. 1B
Details
295-423-2
92045-42-6
Carc. 1B
Details
307-034-8
97488-95-4
Carc. 1B
Details
A complex combination of hydrocarbons obtained by solvent deparaffination of the distillation residue from hydrocracked petroleum. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C40 and boiling in the range of approximately 370°C to 550°C (698°F to 1022°F).
305-594-8
94733-15-0
Carc. 1B
Details
A complex combination of hydrocarbons obtained by solvent deparaffination of the hydrogenated raffinate obtained by solvent extraction of a hydrotreated petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C40 and boiling in the range of approximately 370°C to 550°C (698°F to 1022°F).
305-595-3
94733-16-1
Carc. 1B
Details
295-424-8
92045-43-7
Carc. 1B
Details
202-729-1
99-09-2
Acute Tox. 3; STOT RE 2
Details
202-360-6
94-74-6
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details
213-447-3
950-10-7
Acute Tox. 1; Acute Tox. 2
Details
213-449-4
950-37-8
Acute Tox. 2; Acute Tox. 4
Details
DHPPME; MAK-ME; MEHPOPS; R-MAQ-ME
411-950-4
96562-58-2
Eye Dam. 1
Details
D,L-ESTER
411-040-7
97101-46-7
Acute Tox. 4; Skin Sens. 1
Details
431-720-7
90886-53-6
Skin Corr. 1B; Acute Tox. 4
Details
202-500-6
96-33-3
Flam. Liq. 2; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2; Skin Sens. 1
Details
202-501-1
96-34-4
Flam. Liq. 3; Acute Tox. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
Details
CM 23-376; REOMET 30
401-280-0
91273-04-0
Skin Corr. 1B; Skin Sens. 1
Details
202-088-8
91-66-7
Acute Tox. 3; STOT RE 2
Details
202-805-4
99-97-8
Carc. 1B; Acute Tox. 4; Acute Tox. 3; STOT RE 2
Details
213-103-2
924-42-5
Carc. 1B; Muta. 1B; STOT RE 1
C Carcinogenic (article 57a)
M Mutagen (article 57b)
Details
427-880-2
90357-53-2
STOT RE 2
Details
202-615-1
97-88-1
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Details
202-411-2
95-33-0
Skin Sens. 1
Details
The residue remaining from the distillation of recovered naphtha. Composed primarily of naphthalene and condensation products of indene and styrene.
292-636-2
90641-12-6
Carc. 1B; Muta. 1B
Details
Fraction of the distillate obtained by hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 30°C to 180°C (86°F to 356°F). Composed primarily of aromatic, hydrogenated aromatic and naphthenic compounds, their alkyl derivatives and alkanes with carbon numbers predominantly in the range of C4 to C9. Nitrogen, sulfur and oxygen-containing aromatic and hydrogenated aromatic compounds are also present.
302-690-1
94114-54-2
Carc. 1B; Muta. 1B
Details
A complex combination of hydrocarbons obtained by subjecting a catalytic cracked petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C6 through C12 and boiling in the range of approximately 60°C to 200°C (140°F to 392°F).
295-431-6
92045-50-6
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
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 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 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 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 the fractionation of steam cracked naphtha after recovery from a heat soaking process. It consists predominantly of hydrocarbons having a carbon number predominantly in the range of C4 through C6 and boiling in the range of approximately 0°C to 80°C (32°F to 176°F).
296-028-8
92201-97-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by the treatment and distillation of debenzenized light steam-cracked petroleum naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 95°C to 200°C (203°F to 392°F).
308-713-1
98219-46-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced from the separation and subsequent hydrogenation of the products of a steam-cracking process to produce ethylene. It consists predominantly of saturated and unsaturated paraffins, cyclic paraffins and cyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C4 through C10 and boiling in the range of approximately 50°C to 200°C (122°F to 392°F). The proportion of benzene hydrocarbons may vary up to 30 wt. % and the stream may also contain small amounts of sulphur and oxygenated compounds.
296-942-7
93165-55-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by the treatment and distillation of light steam-cracked petroleum naphtha. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C6 and boiling in the range of approximately 35°C to 80°C (95°F to 176°F).
308-714-7
98219-47-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by subjecting a petroleum distillate from the high temperature thermal cracking of heavy oil fractions to a sweetening process to convert mercaptans. It consists predominantly of aromatics, olefins and saturated hydrocarbons boiling in the range of approximately 20°C to 100°C (68°F to 212°F).
295-447-3
92045-65-3
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
307-035-3
97488-96-5
Carc. 1B
Details
A complex combination of hydrocarbons produced by the distillation of the products from a steam cracking process thereafter treated with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers in the range of C9 through C10 and boiling in the range of approximately 140°C to 200°C (284°F to 392°F).
292-637-8
90641-13-7
Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by alkylation of butanes. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C4 through C12, rich in isooctane, and boiling in the range of approximately 35°C to 210°C (95°F to 410°F).
295-430-0
92045-49-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details

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