EU-IMPLANTABLE_MEDICAL_DEVICES-ART_3_ANX_1

Active Implantable Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Directive 90/385/EEC on Active Implantable Medical Devices, 20 July 1990, amended by Directive 2007/47/EC, 21 September 2007

This list contains hazardous substances for purposes of Directive 90/385/EEC on active implantable medical devices, particularly as regards Article 3 and Annex I (Essential Requirements). This 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). Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021. Nevertheless, Article 120 of the Regulation provides for a transitional period allowing medical devices, under specified conditions (e.g., placed on the market prior to 26 May 2021), to continue to comply with the Directive. In accordance with the fourth paragraph of Article 120, this period ends 26 May 2025.

Last updated 21 June 2024. Database contains 4753 unique substances/entries.
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231-667-8
7681-49-4
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
200-548-2
62-74-8
Acute Tox. 2; Acute Tox. 1
231-587-3
7646-69-7
Water-react. 1
231-665-7
7681-38-1
Eye Dam. 1
231-548-0
7631-90-5
Acute Tox. 4
215-185-5
1310-73-2
Skin Corr. 1A
231-668-3
7681-52-9
Skin Corr. 1B; Eye Dam. 1
231-673-0
7681-57-4
Acute Tox. 4; Eye Dam. 1
204-699-5
124-41-4
Self-heat. 1; Skin Corr. 1B
218-953-8
2302-17-2
Skin Sens. 1
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
231-555-9
7632-00-0
Ox. Sol. 3; Acute Tox. 3
239-172-9
15120-21-5
Ox. Sol. 2; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
239-172-9
15120-21-5
yes
239-172-9
15120-21-5
Ox. Sol. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
231-511-9
7601-89-0
Ox. Sol. 1; Acute Tox. 4
215-209-4
1313-60-6
Ox. Sol. 1; Skin Corr. 1A
231-556-4
7632-04-4
Ox. Sol. 2; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
231-556-4
7632-04-4
Ox. Sol. 2; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
231-556-4
7632-04-4
yes
215-686-9
1344-08-7
Acute Tox. 3; Skin Corr. 1B
223-498-3
3926-62-3
Acute Tox. 3; Skin Irrit. 2
219-007-7
2312-76-7
Acute Tox. 3; STOT RE 2
233-267-9
10102-18-8
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
205-025-2
131-52-2
Carc. 2; Acute Tox. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
287-500-4
85536-19-2
Carc. 1B; Muta. 1B
287-498-5
85536-17-0
Carc. 1B; Muta. 1B
287-502-5
85536-20-5
Carc. 1B; Muta. 1B
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
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
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
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
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
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
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
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
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
232-142-6
7789-06-2
Carc. 1B; Acute Tox. 4
yes
234-239-9
11005-63-3
Acute Tox. 3; STOT RE 2
269-710-8
68310-42-9
Acute Tox. 2
269-439-5
68239-26-9
Acute Tox. 2
200-319-7
57-24-9
Acute Tox. 1; Acute Tox. 2
202-851-5
100-42-5
Flam. Liq. 3; Repr. 2; Acute Tox. 4; STOT RE 1; Skin Irrit. 2; Eye Irrit. 2
202-476-7
96-09-3
Carc. 1B; Acute Tox. 4; Eye Irrit. 2
232-752-2
9014-01-1
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1
203-570-0
108-30-5
Acute Tox. 4; Skin Corr. 1; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
202-388-9
95-06-7
Carc. 1B; Acute Tox. 4
222-995-2
3689-24-5
Acute Tox. 1; Acute Tox. 2
231-722-6
7704-34-9
Skin Irrit. 2
263-467-1
62229-08-7
yes

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