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 11 listopada 2024. Database contains 4918 unique substances/entries.
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211-952-3
719-96-0
Skin Irrit. 2
Details
213-103-2
924-42-5
Carc. 1B; Muta. 1B; STOT RE 1
C Carcinogenic (article 57a)
M Mutagen (article 57b)
Details
205-223-9
135-88-6
Carc. 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
204-658-1
123-86-4
Flam. Liq. 3; STOT SE 3
Details
205-480-7
141-32-2
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Details
202-615-1
97-88-1
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Details
209-669-5
590-01-2
Flam. Liq. 3
Details
203-700-6
109-74-0
Flam. Liq. 2; Acute Tox. 3
Details
200-652-8
67-43-6
Repr. 1B; Acute Tox. 4; STOT RE 2; Eye Irrit. 2
Details
202-411-2
95-33-0
Skin Sens. 1
Details
220-250-6
2687-91-4
Repr. 1B
Details
203-135-5
103-69-5
Acute Tox. 3; STOT RE 2
Details
203-777-6
110-54-3
Flam. Liq. 2; Repr. 2; Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; STOT SE 3
Details
202-969-7
101-72-4
Acute Tox. 4; Skin Sens. 1
Details
212-828-1
872-50-4
Repr. 1B; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2
R Toxic for reproduction (article 57c)
Details
211-795-0
696-44-6
Acute Tox. 3; STOT RE 2
Details
207-531-9
479-45-8
Expl. 1.1; Acute Tox. 3; STOT RE 2
Details
210-260-9
611-21-2
Acute Tox. 3; STOT RE 2
Details
210-769-6
623-08-5
Acute Tox. 3; STOT RE 2
Details
201-182-6
79-16-3
Repr. 1B
R Toxic for reproduction (article 57c)
Details
202-870-9
100-61-8
Acute Tox. 3; STOT RE 2
Details
204-624-6
123-39-7
Repr. 1B; Acute Tox. 4
Details
218-130-3
2051-79-8
Acute Tox. 3; Eye Irrit. 2; Skin Sens. 1
Details
205-547-0
142-59-6
Acute Tox. 4; STOT SE 3; Skin Sens. 1
Details
206-098-3
300-76-5
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
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
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 C12 and boiling in the range of approximately minus 10°C to 230°C (14°F to 446°F).
265-089-2
64741-87-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
271-635-0
68603-08-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
272-185-8
68783-09-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained from the catalytic dewaxing of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C12 and boiling in the range of approximately 35°C to 230°C (95°F to 446°F).
265-170-2
64742-66-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by fractionation from catalytically reformed hydrodesulfurized naphtha. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 to C13 and boiling in the range of approximately 98°C to 218°C (208°F to 424°F).
285-508-2
85116-57-0
Asp. Tox. 1
Details
A complex combination of hydrocarbons remaining after removal of aromatic compounds from catalytic reformed light naphtha in a selective absorption process. It consists predominantly of paraffinic and cyclic compounds having carbon numbers predominantly in the range of C5 to C8 and boiling in the range of approximately 66°C to 121°C (151°F to 250°F).
285-510-3
85116-59-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by the distillation of products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C12 and boiling in the range of approximately 30°C to 220°C (90°F to 430°F). It contains a relatively large proportion of aromatic and branched chain hydrocarbons. This stream may contain 10 vol. % or more benzene.
273-271-8
68955-35-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
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 C6 through C12 and boiling in the range of approximately 65°C to 230°C (149°F to 446°F).
265-122-0
64742-22-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
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 C4 through C11 and boiling in the range of approximately minus 20°C to 190°C (-4°F to 374°F).
265-123-6
64742-23-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons resulting from treatment of full-range straight-run naphtha with natural or modified clay, usually in a percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately -20°C to 220°C (-4°F to 429°F).
271-262-3
68527-21-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons resulting from treatment of light straight-run naphtha with a natural or modified clay, usually in a percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C7 through C10 and boiling in the range of approximately 93°C to 180°C (200°F to 356°F).
271-263-9
68527-22-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by the distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 through C5. It consists of predominantly branched chain saturated hydrocarbons having carbon numbers predominantly in the range of C7 through C12 with some butanes and boiling in the range of approximately 35°C to 200°C (95°F to 428°F).
271-267-0
68527-27-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 through C5. It consists of predominantly branched chain saturated hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90°C to 220°C (194°F to 428°F).
265-066-7
64741-64-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by the distillation of products from a fluid coker. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C4 through C15 and boiling in the range of approximately 43°C to 250°C(110°F-500°F).
270-991-4
68513-02-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by the distillation of the products from a catalytic reforming process. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C12 and boiling in the range of approximately 35°C to 230°C (95°F to 446°F).
272-895-8
68919-37-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately minus 20°C to 220°C (-4°F to 428°F).
265-042-6
64741-42-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by distillation of the reaction products of isobutane with monoolefinic hydrocarbons usually ranging in carbon numbers from C3 to C5. It consists of predominantly branched chain saturated hydrocarbons having carbon numbers predominantly in the range of C9 through C12 and boiling in the range of approximately 150°C to 220°C (302°F to 428°F).
265-067-2
64741-65-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
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 produced by a distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C6 through C12 and boiling in the range of approximately 65°C to 230°C (148°F to 446°F). It contains a relatively large proportion of unsaturated hydrocarbons.
265-055-7
64741-54-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced from the distillation of products from a catalytic reforming process. It consists of predominantly aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C12 and boiling in the range of approximately 90°C to 230°C (194°F to 446°F).
265-070-9
64741-68-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons from the distillation of products from a fluid coker. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C6 through C15 and boiling in the range of approximately 157°C to 288°C (315°F to 550°F).
269-778-9
68333-23-3
Asp. Tox. 1
Details
A complex combination of hydrocarbons from distillation of the products from a hydrocracking process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C6 through C12, and boiling in the range of approximately 65°C to 230°C (148°F to 446°F).
265-079-8
64741-78-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons produced by distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C6 through C12 and boiling in the range of approximately 65°C to 230°C (149°F to 446°F).
265-041-0
64741-41-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons from distillation of the products from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C6 through C12 and boiling in the range of approximately 65°C to 220°C (148°F to 428°F).
265-085-0
64741-83-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details

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