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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 19 June 2024. Database contains 4753 unique substances/entries.
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223-874-7
4104-14-7
Acute Tox. 1; Acute Tox. 2
218-996-2
2310-17-0
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
213-423-2
947-02-4
Acute Tox. 1; Acute Tox. 2
200-870-3
75-44-5
Press. Gas; Acute Tox. 2; Skin Corr. 1B
211-987-4
732-11-6
Repr. 2; Acute Tox. 4; Acute Tox. 3; STOT SE 1
236-116-5
13171-21-6
Muta. 2; Acute Tox. 2; Acute Tox. 3
232-260-8
7803-51-2
Flam. Gas 1; Press. Gas; Acute Tox. 1; Skin Corr. 1B
237-066-7
13598-36-2
Acute Tox. 4; Skin Corr. 1A
231-633-2
7664-38-2
Skin Corr. 1B
233-663-1
10294-56-1
Acute Tox. 4; Skin Corr. 1A
233-060-3
10026-13-8
Acute Tox. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
215-236-1
1314-56-3
Skin Corr. 1A
232-178-2
7789-60-8
Skin Corr. 1B; STOT SE 3
231-749-3
7719-12-2
Acute Tox. 2; STOT RE 2; Skin Corr. 1A
233-046-7
10025-87-3
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Skin Corr. 1A
238-887-3
14816-18-3
Repr. 2; Acute Tox. 4; Skin Sens. 1
201-607-5
85-44-9
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
200-332-8
57-47-6
Acute Tox. 2
202-128-4
92-13-7
Acute Tox. 2
201-462-8
83-26-1
Acute Tox. 3; STOT RE 1
203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
203-808-3
110-85-0
Repr. 2; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1
205-551-2
142-64-3
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
228-042-7
6094-40-2
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
217-775-8
1951-97-9
Repr. 2; Eye Irrit. 2; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
203-813-0
110-89-4
Flam. Liq. 2; Acute Tox. 3; Skin Corr. 1B
245-430-1
23103-98-2
Carc. 2; Acute Tox. 3; Skin Sens. 1
245-704-0
23505-41-1
Acute Tox. 3; Acute Tox. 4
249-528-5
29232-93-7
Acute Tox. 4; STOT RE 1
The residue from the distillation of high temperature coal tar. A black solid with an approximate softening point from 30°C to 180°C (86°F to 356°F). Composed primarily of a complex mixture of three or more membered condensed ring aromatic hydrocarbons.
266-028-2
65996-93-2
Carc. 1A; Muta. 1B; Repr. 1B
yes
A complex black solid obtained by the heat treatment of low temperature coal tar pitch. It has a softening point within the approximate range of 50°C to 140°C (122°F to 284°F). Composed primarily of a complex mixture of aromatic compounds.
292-653-5
90669-58-2
Carc. 1B
The product obtained by air-blowing, at elevated temperature, low-temperature coal tar pitch. It has a softening-point within the approximate range of 70°C to 180°C (158°F to 356°F). Composed primarily of a complex mixture of hydrocarbons.
292-654-0
90669-59-3
Carc. 1B
A complex black solid or semi-solid obtained from the distillation of a low temperature coal tar. It has a softening point within the approximate range of 40°C to 180°C (104°F to 356°F). Composed primarily of a complex mixture of hydrocarbons.
292-651-4
90669-57-1
Carc. 1B
The residue from the distillation of a mixture of coal tar and aromatic petroleum streams. A solid with a softening point from 40°C to 180°C (104°F to 356°F). Composed primarily of a complex combination of three or more membered condensed ring aromatic hydrocarbons.
269-109-0
68187-57-5
Carc. 1B
263-072-4
61789-60-4
Carc. 1B
215-648-1
1336-36-3
STOT RE 2
231-119-8
7440-09-7
Water-react. 1; Skin Corr. 1B
246-376-1
24634-61-5
Eye Irrit. 2
266-578-3
67118-55-2
yes
233-002-7
10007-85-9
Eye Irrit. 2
232-156-2
7789-29-9
Acute Tox. 3; Skin Corr. 1B
231-829-8
7758-01-2
Ox. Sol. 1; Carc. 1B; Acute Tox. 3
223-289-7
3811-04-9
Ox. Sol. 1; Acute Tox. 4
232-140-5
7789-00-6
Carc. 1B; Muta. 1B; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
yes
209-676-3
590-28-3
Acute Tox. 4
231-906-6
7778-50-9
Ox. Sol. 2; 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
yes
213-029-0
917-58-8
Self-heat. 1; Skin Corr. 1B
232-151-5
7789-23-3
Acute Tox. 3
231-594-1
7646-93-7
Skin Corr. 1B; STOT SE 3
215-181-3
1310-58-3
Acute Tox. 4; Skin Corr. 1A

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