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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 28 May 2024. Database contains 4753 unique substances/entries.
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247-852-1
26628-22-8
Acute Tox. 2
218-953-8
2302-17-2
Skin Sens. 1
219-007-7
2312-76-7
Acute Tox. 3; STOT RE 2
430-090-0
205764-96-1
Eye Dam. 1; Skin Sens. 1
606-523-6
203313-25-1
Repr. 2; STOT SE 3; Eye Irrit. 2; Skin Sens. 1A
427-930-3
250639-69-1
Skin Sens. 1
STYRENE SULPHONYL CHLORIDE
404-770-2
2633-67-2
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
220-281-5
2699-79-8
Press. Gas; Acute Tox. 3; STOT RE 2
606-566-0
20487-40-5
Flam. Liq. 2
444-440-5
220689-12-3
Acute Tox. 4
247-570-9
26266-63-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
440-460-3
252579-81-0
Eye Irrit. 2
432-550-6
243858-01-7
Eye Dam. 1
220-012-1
2602-46-2
Carc. 1B; Repr. 2
246-901-4
25366-23-8
Acute Tox. 4
248-924-5
28249-77-6
Acute Tox. 4
206-049-6
297-97-2
Acute Tox. 1; Acute Tox. 2
245-740-7
23564-05-8
Muta. 2; Acute Tox. 4; Skin Sens. 1
218-962-7
2303-17-5
Acute Tox. 4; STOT RE 2; Skin Sens. 1
432-270-4
221354-37-6
Repr. 2; STOT RE 2
-
26766-27-8
Acute Tox. 4
245-986-5
24017-47-8
Acute Tox. 3; Acute Tox. 4
246-347-3
24602-86-6
Repr. 1B; Acute Tox. 4; Skin Irrit. 2
219-014-5
2314-97-8
Muta. 2
220-449-8
2768-02-7
Skin Sens. 1B
247-759-6
26523-78-4
Skin Sens. 1
yes
427-710-7
215612-56-9
Eye Dam. 1; Skin Sens. 1
429-240-8
212652-59-0
Eye Dam. 1
246-677-8
25155-23-1
Repr. 1B
yes
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
D,L-VALINEAMIDE
402-840-7
20108-78-5
Repr. 2; Eye Irrit. 2; Skin Sens. 1
218-894-8
2275-23-2
Acute Tox. 3; Acute Tox. 4
607-955-8
2655-14-3
Acute Tox. 4
219-364-9
2425-10-7
Acute Tox. 4
444-480-3
393517-29-8
Skin Irrit. 2
222-048-3
3327-22-8
Carc. 2
HEXAROSE
421-370-3
3681-73-0
Skin Irrit. 2
420-610-4
36394-75-9
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
222-323-8
3425-89-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
221-695-9
3194-55-6
Repr. 2; Lact.
yes
DE 3
413-140-6
3459-83-4
Flam. Liq. 3
221-641-4
3173-72-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
MIXOFAM
411-510-1
3353-51-3
Skin Sens. 1
434-480-1
32047-53-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
METHOXYISOPROPYLAMINE
422-550-4
37143-54-7
Flam. Liq. 2; Skin Corr. 1B; Acute Tox. 4
448-720-8
363138-44-7
Acute Tox. 4; Eye Dam. 1
221-967-7
3296-90-0
Carc. 1B; Muta. 1B
N,N DIMETHYL DIETHOXY-2,2 ACETAMIDE
449-950-1
34640-92-1
Eye Irrit. 2
2,3,4-TRIFLUORANILIN
407-170-9
3862-73-5
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1

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