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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 May 2024. Database contains 4753 unique substances/entries.
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208-885-7
545-06-2
Acute Tox. 3
201-167-4
79-01-6
Carc. 1B; Muta. 2; Eye Irrit. 2; Skin Irrit. 2; STOT SE 3
yes
213-608-8
993-16-8
Repr. 2
206-326-1
327-98-0
Acute Tox. 2; Acute Tox. 3
200-930-9
76-06-2
Acute Tox. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
233-042-5
10025-78-2
Flam. Liq. 1; Pyr. Liq. 1; Acute Tox. 4; Skin Corr. 1A
222-182-2
3380-34-5
Eye Irrit. 2; Skin Irrit. 2
206-203-2
307-55-1
yes
215-548-8
1330-78-5
STOT SE 1
215-548-8
1330-78-5
Acute Tox. 4
255-559-5
41814-78-2
Acute Tox. 4
274-462-9
70225-16-0
yes
246-347-3
24602-86-6
Repr. 1B; Acute Tox. 4; Skin Irrit. 2
201-114-5
78-40-0
Acute Tox. 4
204-469-4
121-44-8
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
215-812-2
1420-06-0
Acute Tox. 4
200-929-3
76-05-1
Acute Tox. 4; Skin Corr. 1A
219-014-5
2314-97-8
Muta. 2
216-428-8
1582-09-8
Carc. 2; Skin Sens. 1
235-688-3
12519-85-6
Carc. 1A; STOT RE 1; Skin Sens. 1
215-290-6
1319-46-6
yes
231-205-5
7446-27-7
Repr. 1A; STOT RE 2
222-979-5
3687-31-8
yes
235-252-2
12141-20-7
yes
220-449-8
2768-02-7
Skin Sens. 1B
204-468-9
121-43-7
Flam. Liq. 3; Acute Tox. 4
257-765-0
52234-82-9
Muta. 2; Eye Dam. 1; Skin Sens. 1
236-771-7
13477-70-8
Carc. 1A; STOT RE 1; Skin Sens. 1
233-844-5
10381-36-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
234-495-1
12007-02-2
Carc. 1A; STOT RE 1; Skin Sens. 1
234-829-6
12035-72-2
Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1
202-908-4
101-02-0
Eye Irrit. 2; Skin Irrit. 2
204-118-5
115-96-8
Carc. 2; Repr. 1B; Acute Tox. 4
yes
213-934-0
1067-53-4
Repr. 1B
247-759-6
26523-78-4
Skin Sens. 1
yes
237-159-2
13674-87-8
Carc. 2
237-410-6
13775-53-6
STOT RE 1; Acute Tox. 4
239-148-8
15096-52-3
STOT RE 1; Acute Tox. 4
225-768-6
5064-31-3
Carc. 2; Acute Tox. 4; Eye Irrit. 2
246-677-8
25155-23-1
Repr. 1B
yes
215-244-5
1314-84-7
Water-react. 1; Acute Tox. 2
218-828-8
2244-21-5
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
220-767-7
2893-78-9
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
232-650-8
9002-07-7
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
Any of the volatile predominately terpenic fractions or distillates resulting from the solvent extraction of, gum collection from, or pulping of softwoods. Composed primarily of the C10H16 terpene hydrocarbons: α-pinene, β-pinene, limonene, 3-carene, camphene. May contain other acyclic, monocyclic, or bicyclic terpenes, oxygenated terpenes, and anethole. Exact composition varies with refining methods and the age, location, and species of the softwood source.
232-350-7
8006-64-2
Flam. Liq. 3; Acute Tox. 4; Asp. Tox. 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
231-170-6
7440-61-1
Acute Tox. 2; STOT RE 2
200-123-1
51-79-6
Carc. 1B
203-677-2
109-52-4
Skin Corr. 1B
218-894-8
2275-23-2
Acute Tox. 3; Acute Tox. 4
217-681-7
1929-77-7
Acute Tox. 4

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