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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 27 May 2024. Database contains 4753 unique substances/entries.
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243-761-6
20354-26-1
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
M-TMI
402-440-2
2094-99-7
Acute Tox. 2; Skin Corr. 1B; STOT RE 2; Resp. Sens. 1; Skin Sens. 1
443-980-9
221215-20-9
Skin Sens. 1
220-548-6
2807-30-9
Acute Tox. 4; Eye Irrit. 2
243-816-4
20427-84-3
yes
425-160-2
24085-06-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
DEBROPOL
407-030-7
24403-04-1
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
426-540-0
2973-59-3
Skin Sens. 1
430-470-6
2065-75-0
Acute Tox. 4; Eye Dam. 1
433-890-8
2040-90-6
Muta. 1B; Repr. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
POLLENAL II
412-270-0
2109-22-0
Skin Sens. 1
220-688-8
2867-47-2
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
220-852-9
2918-23-2
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
695-989-4
2527-66-4
Acute Tox. 4; Acute Tox. 3; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
ROSAPHEN
405-890-8
25634-93-9
Eye Irrit. 2; Skin Irrit. 2
219-449-0
2438-20-2
Flam. Liq. 3
220-239-6
2682-20-4
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Eye Dam. 1; Skin Sens. 1A
427-720-1
26364-65-8
Acute Tox. 4; STOT RE 2
248-743-1
27942-27-4
yes
219-682-8
2497-59-8
yes
247-816-5
26571-11-9
yes
431-500-0
226065-73-2
Skin Sens. 1
219-374-3
2426-02-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
429-130-1
2820-37-3
Acute Tox. 4; Eye Dam. 1
220-630-1
2840-00-8
Acute Tox. 4
218-951-7
2300-66-5
Eye Irrit. 2
606-640-2
2079-00-7
Acute Tox. 2
AMPCPA
417-480-6
252977-62-1
Skin Sens. 1
220-666-8
2855-13-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
445-590-4
202197-26-0
Muta. 2; Acute Tox. 4; STOT RE 2
220-426-2
2761-09-3
Eye Irrit. 2; Skin Sens. 1
-
2532-43-6
Acute Tox. 3
432-530-7
24294-01-7
Acute Tox. 4
DMA
407-500-1
21983-80-2
Skin Sens. 1
HMPSC
403-330-7
24197-34-0
Eye Dam. 1
CARBONATE DE TETRACHLOROETHYLENE
404-060-2
22432-68-4
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
621-341-7
2315-61-9
yes
426-900-7
203118-12-1
STOT SE 3
431-200-1
208538-34-5
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
RO 827
412-090-2
2788-74-1
Acute Tox. 4; Skin Sens. 1
430-840-7
202483-63-4
Skin Sens. 1
1 - 2.5 moles ethoxylated
500-045-0
26027-38-3
yes
621-345-9
2315-67-5
yes
FAT 92'374
413-480-5
24856-00-6
Acute Tox. 4; Skin Sens. 1
435-000-3
22094-83-3
Asp. Tox. 1; Skin Irrit. 2
428-330-4
2833-30-9
Skin Corr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
429-960-2
27610-48-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
IMEXINE OBA
417-020-4
2380-86-1
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
FLEUROXENE
430-830-2
26912-64-1
Skin Irrit. 2
421-940-1
28698-31-9
Eye Dam. 1

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