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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 13 June 2024. Database contains 4753 unique substances/entries.
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204-123-2
116-06-3
Acute Tox. 2; Acute Tox. 3
240-896-2
16871-90-2
Acute Tox. 3
240-934-8
16893-85-9
Acute Tox. 3
240-968-3
16919-19-0
Acute Tox. 3
203-470-7
107-18-6
Flam. Liq. 2; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-442-4
106-92-3
Flam. Liq. 3; Carc. 2; Muta. 2; Repr. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
203-463-9
107-11-9
Flam. Liq. 2; Acute Tox. 3
603-801-9
134237-50-6
yes
240-877-9
16853-85-3
Water-react. 1; Skin Corr. 1A
604-314-4
142844-00-6
yes
215-647-6
1336-21-6
Skin Corr. 1B
215-676-4
1341-49-7
Acute Tox. 3; Skin Corr. 1B
AIZEN SPILON BLACK TRH; AIZEN SPILON SCHWARZ TRH; THR-1; TRH
400-110-2
109125-51-1
Self-react. C
235-186-4
12125-02-9
Acute Tox. 4; Eye Irrit. 2
235-185-9
12125-01-8
Acute Tox. 3
433-560-3
15375-21-0
Repr. 2
202-910-5
101-05-3
Eye Irrit. 2; Skin Irrit. 2
204-371-1
120-12-7
yes
233-047-2
10025-91-9
Skin Corr. 1B
215-175-0
1309-64-4
Carc. 2
A complex combination of hydrocarbons obtained from mixed coal tar pitch-polyethylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-957-1
101794-75-6
Carc. 1B
A complex combination hydrocarbons obtained from mixed coal tar pitch-polyethylene-polypropylene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-956-6
101794-74-5
Carc. 1B
A complex combination of hydrocarbons obtained from mixed coal tar pitch-polystyrene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-958-7
101794-76-7
Carc. 1B
601-649-8
12001-28-4
Carc. 1A; STOT RE 1
601-801-3
12172-73-5
Carc. 1A; STOT RE 1
601-650-3
12001-29-5
Carc. 1A; STOT RE 1
-
132207-32-0
Carc. 1A; STOT RE 1
217-617-8
1912-24-9
STOT RE 2; Skin Sens. 1
203-102-5
103-33-3
Carc. 1B; Muta. 2; Acute Tox. 4; STOT RE 2
603-524-3
131860-33-8
Acute Tox. 3
202-930-4
101-27-9
Acute Tox. 4; Skin Sens. 1
431-780-4
199876-46-5
Acute Tox. 4; STOT RE 2
236-760-7
13477-00-4
Ox. Sol. 1; Acute Tox. 4
233-788-1
10361-37-2
Acute Tox. 3; Acute Tox. 4
236-710-4
13465-95-7
Ox. Sol. 1; Acute Tox. 4
215-128-4
1304-29-6
Ox. Sol. 2; Acute Tox. 4
LEXQUAT AMG-BEO (CONCENTRATE)
423-420-1
136920-10-0
Eye Dam. 1; Skin Sens. 1
241-775-7
17804-35-2
Muta. 1B; Repr. 1B; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
605-769-1
17606-31-4
Acute Tox. 4
202-860-4
100-52-7
Acute Tox. 4
205-892-7
192-97-2
Carc. 1B
205-883-8
191-24-2
yes
205-877-5
189-55-9
Carc. 1B; Muta. 2
431-600-4
112226-61-6
Skin Sens. 1
202-855-7
100-47-0
Acute Tox. 4
205-736-8
149-30-4
Skin Sens. 1
691-719-4
1072957-71-1
Acute Tox. 3
217-685-9
1929-88-0
Acute Tox. 4
202-859-9
100-51-6
Acute Tox. 4
204-402-9
120-51-4
Acute Tox. 4

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