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 15 srpnja 2024. Database contains 4917 unique substances/entries.
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263-560-7
62476-59-9
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
Details
247-852-1
26628-22-8
Acute Tox. 2
Details
215-608-3
1333-83-1
Acute Tox. 3; Skin Corr. 1B
Details
207-838-8
497-19-8
Eye Irrit. 2
Details
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
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
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. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
Details
239-172-9
15120-21-5
Ox. Sol. 2; Repr. 1B; 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
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
R Toxic for reproduction (article 57c)
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
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
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 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 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 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 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 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
293-901-5
91648-39-4
Repr. 1B; STOT RE 1
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
232-142-6
7789-06-2
Carc. 1B; Acute Tox. 4
C Carcinogenic (article 57a)
Details

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