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 04 listopada 2024. Database contains 4917 unique substances/entries.
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231-887-4
7775-09-9
Ox. Sol. 1; Acute Tox. 3
Details
231-889-5
7775-11-3
Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
C Carcinogenic (article 57a)
M Mutagen (article 57b)
R Toxic for reproduction (article 57c)
Details
213-030-6
917-61-3
Acute Tox. 4
Details
616-541-6
7789-12-0
C Carcinogenic (article 57a)
M Mutagen (article 57b)
R Toxic for reproduction (article 57c)
Details
234-190-3
10588-01-9
Ox. Sol. 2; Carc. 1B; Muta. 1B; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
C Carcinogenic (article 57a)
M Mutagen (article 57b)
R Toxic for reproduction (article 57c)
Details
231-890-0
7775-14-6
Self-heat. 1; Acute Tox. 4
Details
205-487-5
141-52-6
Self-heat. 1; Skin Corr. 1B
Details
231-667-8
7681-49-4
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
Details
200-548-2
62-74-8
Acute Tox. 2; Acute Tox. 1
Details
231-587-3
7646-69-7
Water-react. 1
Details
231-665-7
7681-38-1
Eye Dam. 1
Details
231-548-0
7631-90-5
Acute Tox. 4
Details
215-185-5
1310-73-2
Skin Corr. 1A
Details
231-668-3
7681-52-9
Skin Corr. 1B; Eye Dam. 1
Details
231-673-0
7681-57-4
Acute Tox. 4; Eye Dam. 1
Details
204-699-5
124-41-4
Self-heat. 1; Skin Corr. 1B
Details
218-953-8
2302-17-2
Skin Sens. 1
Details
274-357-8
70161-44-3
Carc. 1B; Muta. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Irrit. 2; Skin Sens. 1
Details
231-555-9
7632-00-0
Ox. Sol. 3; Acute Tox. 3
Details
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3830-45-3
Carc. 2; Repr. 1B; Lact.
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
Details
239-172-9
15120-21-5
R Toxic for reproduction (article 57c)
Details
239-172-9
15120-21-5
Ox. Sol. 2; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
239-172-9
15120-21-5
Ox. Sol. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
231-511-9
7601-89-0
Ox. Sol. 1; Acute Tox. 4
Details
243-518-4
20109-59-5
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
Details
215-209-4
1313-60-6
Ox. Sol. 1; Skin Corr. 1A
Details
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-
Ox. Sol. 2; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
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-
Ox. Sol. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
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-
Repr. 1B; STOT SE 3; Eye Dam. 1
Details
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-
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
231-556-4
7632-04-4
R Toxic for reproduction (article 57c)
Details
231-556-4
7632-04-4
Ox. Sol. 2; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
231-556-4
7632-04-4
Ox. Sol. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
215-686-9
1344-08-7
Acute Tox. 3; Skin Corr. 1B
Details
435-350-7
141250-43-3
Eye Dam. 1
Details
223-498-3
3926-62-3
Acute Tox. 3; Skin Irrit. 2
Details
219-007-7
2312-76-7
Acute Tox. 3; STOT RE 2
Details
233-267-9
10102-18-8
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
Details
430-090-0
205764-96-1
Eye Dam. 1; Skin Sens. 1
Details
205-025-2
131-52-2
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
Details
287-500-4
85536-19-2
Carc. 1B; Muta. 1B
Details
287-498-5
85536-17-0
Carc. 1B; Muta. 1B
Details
287-502-5
85536-20-5
Carc. 1B; Muta. 1B
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
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
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 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 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 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 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

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