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 19 srpnja 2024. Database contains 4917 unique substances/entries.
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231-639-5
7664-93-9
Skin Corr. 1A
Details
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13451-08-6
Skin Corr. 1B
Details
231-195-2
7446-09-5
Press. Gas; Acute Tox. 3; STOT SE 1; Skin Corr. 1B
Details
234-129-0
10545-99-0
Skin Corr. 1B; STOT SE 3
Details
204-482-5
121-57-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
Details
226-218-8
5329-14-6
Eye Irrit. 2; Skin Irrit. 2
Details
231-722-6
7704-34-9
Skin Irrit. 2
Details
807-366-8
946578-00-3
Acute Tox. 4
Details
222-995-2
3689-24-5
Acute Tox. 1; Acute Tox. 2
Details
202-388-9
95-06-7
Carc. 1B; Acute Tox. 4
Details
619-394-6
99105-77-8
Repr. 2; STOT RE 2; Skin Sens. 1A
Details
203-570-0
108-30-5
Acute Tox. 4; Skin Corr. 1; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
Details
232-752-2
9014-01-1
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1
Details
STYRENE SULPHONYL CHLORIDE
404-770-2
2633-67-2
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
Details
202-476-7
96-09-3
Carc. 1B; Acute Tox. 4; Eye Irrit. 2
Details
202-851-5
100-42-5
Flam. Liq. 3; Repr. 2; Acute Tox. 4; STOT RE 1; Skin Irrit. 2; Eye Irrit. 2
Details
200-319-7
57-24-9
Acute Tox. 1; Acute Tox. 2
Details
269-439-5
68239-26-9
Acute Tox. 2
Details
269-710-8
68310-42-9
Acute Tox. 2
Details
234-239-9
11005-63-3
Acute Tox. 3; STOT RE 2
Details
427-930-3
250639-69-1
Skin Sens. 1
Details
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P Parasites
Details
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P Parasites
Details
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B Bacteria and similar species
Details
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B Bacteria and similar species
Details
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B Bacteria and similar species
Details
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B Bacteria and similar species
Details
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B Bacteria and similar species
Details
A colorless, refined petroleum distillate that is free from rancid or objectionable odors and that boils in a range of approximately 148.8°C to 204.4°C (300°F to 400°F).
232-489-3
8052-41-3
Carc. 1B; Muta. 1B; STOT RE 1; Asp. Tox. 1
Details
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B Bacteria and similar species
Details
293-901-5
91648-39-4
Repr. 1B; STOT RE 1
Details
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
Details
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F Fungi
Details
601-505-4
118134-30-8
Repr. 2; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Skin Sens. 1
Details
606-523-6
203313-25-1
Repr. 2; STOT SE 3; Eye Irrit. 2; Skin Sens. 1A
Details
604-636-5
148477-71-8
Carc. 1B; Repr. 2; STOT RE 2; Skin Sens. 1B
Details
A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C9 through C12 and boiling in the range of approximately 140°C to 220°C (284°F to 428°F).
265-191-7
64742-88-7
STOT RE 1; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained from distillation of aromatic streams. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 135°C to 210°C (275°F to 410°F).
265-199-0
64742-95-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C8 through C10 and boiling in the range of approximately 135°C to 210°C(275°F to 410°F).
270-988-8
68512-78-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C5 through C10 and boiling in the range of approximately 35°C to 160°C (95°F to 320°F).
265-192-2
64742-89-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists predominantly of cycloparaffinic hydrocarbons having carbon numbers predominantly in the range of C6 through C7 and boiling in the range of approximately 73°C to 85°C (163°F to 185°F).
295-529-9
92062-15-2
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by the catalytic hydrodesulfurization of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C13 and boiling in the range of approximately 175°C to 220°C (347°F to 428°F).
309-884-5
101316-82-9
Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by the catalytic hydrodesulfurization of a petroleum fraction. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C13 and boiling in the range of approximately 180°C to 240°C (356°F to 464°F).
309-882-4
101316-81-8
Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained by the distillation of hydrocracked petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 235°C to 290°C (455°F to 554°F).
309-881-9
101316-80-7
Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained from distillation of aromatic streams. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 165°C to 290°C (330°F to 554°F).
265-198-5
64742-94-5
Asp. Tox. 1
Details
A complex combination of hydrocarbons obtained from the distillation of crude oil or natural gasoline. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C11 through C16 and boiling in the range of approximately 190°C to 290°C (374°F to 554°F).
265-200-4
64742-96-7
Asp. Tox. 1
Details
The distillate from either high temperature coal tar, coke oven light oil, or coal tar oil alkaline extract residue having an approximate distillation range of 130°C to 210°C (266°F to 410°F) Composed primarily of indene and other polycyclic ring systems containing a single aromatic ring. May contain phenolic compounds and aromatic nitrogen bases.
266-013-0
65996-79-4
Carc. 1B; Muta. 1B
Details
287-502-5
85536-20-5
Carc. 1B; Muta. 1B
Details
287-498-5
85536-17-0
Carc. 1B; Muta. 1B
Details
287-500-4
85536-19-2
Carc. 1B; Muta. 1B
Details

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