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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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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209-660-6
589-81-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-643-3
589-34-4
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-526-7
584-02-1
Flam. Liq. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
200-340-1
57-57-8
Carc. 1B; Acute Tox. 2; Eye Irrit. 2; Skin Irrit. 2
209-321-2
569-61-9
Carc. 1B
DIGLYCERINDIFORMAL (DGDF)
423-230-7
56552-15-9
Eye Dam. 1
209-218-2
561-41-1
yes
225-863-2
5124-30-1
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
TRIOXABICYCLOOCTAN; TRIOXABICYCLOOCTANE
421-750-9
57280-22-5
Eye Irrit. 2; Skin Sens. 1
423-860-2
56309-94-5
Skin Sens. 1
257-907-1
52427-13-1
yes
ACRYLOYLMORPHOLIN
418-140-1
5117-12-4
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
635-388-6
521947-27-3
yes
JKY-120
405-730-7
51601-57-1
STOT RE 2
259-980-5
56073-10-0
Repr. 1A; Acute Tox. 1; STOT RE 1
2-METHOXY-4-METHYL-6-METHYLAMINO-1,3,5-TRIAZIN; DPX-L5296; L5296
401-360-5
5248-39-5
Acute Tox. 4; STOT RE 2
209-544-5
584-84-9
Carc. 2; Acute Tox. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
209-650-1
589-53-7
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
-
51-14-9
Acute Tox. 4
208-793-7
541-85-5
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
5-METHYLPYRAZINE-2-CARBOXYLIC ACID; ACIDO 5-METILPIRAZIN CARBOSSILICO
413-260-9
5521-55-1
Eye Dam. 1
256-960-8
51085-52-0
Carc. 2; Acute Tox. 3
8-AMINO-7-METHYLCHINOLIN
412-760-4
5470-82-6
Acute Tox. 4; Skin Sens. 1
611-595-7
57960-19-7
Skin Sens. 1; STOT SE 1; STOT RE 2
257-175-3
51404-69-4
yes
256-634-5
50594-66-6
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
209-542-4
584-79-2;84030-86-4
Acute Tox. 4
209-542-4
584-79-2;84030-86-4
Acute Tox. 4
209-090-8
555-31-7
Flam. Sol. 1
200-104-8
51-55-8
Acute Tox. 2
227-419-3
5834-96-8
Acute Tox. 4
208-167-3
513-77-9
Acute Tox. 4
256-814-3
50864-67-0
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-280-6
56-55-3
Carc. 1B
yes
209-008-0
552-30-7
STOT SE 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
200-028-5
50-32-8
Carc. 1B; Muta. 1B; Repr. 1B; Skin Sens. 1
yes
207-925-0
501-53-1
Skin Corr. 1B
PLR-22; XC95-A0638
414-960-7
53863-99-3
Acute Tox. 4
200-237-1
55-55-0
Acute Tox. 4; STOT RE 2; Skin Sens. 1
208-832-8
542-88-1
Flam. Liq. 2; Carc. 1A; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4
200-268-0
56-35-9
yes
209-800-6
593-60-2
Press. Gas; Flam. Gas 1; Carc. 1B
260-300-4
56634-95-8
Repr. 2; Acute Tox. 4; Skin Sens. 1
200-143-0
52-51-7
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
227-317-9
5786-97-0
Acute Tox. 2
208-077-4
507-60-8
Acute Tox. 2
209-750-5
592-34-7
Flam. Liq. 3; Acute Tox. 3; Skin Corr. 1B
209-772-5
592-84-7
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
208-862-1
544-16-1
Flam. Liq. 2; Acute Tox. 3
208-953-6
548-62-9
Carc. 2; Acute Tox. 4; Eye Dam. 1

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