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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 February 2024. Database contains 4753 unique substances/entries.
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211-000-7
627-44-1
Acute Tox. 2; Acute Tox. 1; STOT RE 2
425-380-9
7397-46-8
Pyr. Liq. 1; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
270-877-4
68479-98-1
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
209-161-3
557-20-0
Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B
IRB
418-070-1
141714-54-7
Skin Sens. 1
600-594-7
104653-34-1
Repr. 1B; Acute Tox. 1; STOT RE 1
200-760-5
71-63-6
Acute Tox. 3; STOT RE 2
201-559-5
84-75-3
Repr. 1B
yes
201-553-2
84-69-5
Repr. 1B
yes
276-090-2
71850-09-4
Repr. 1B
yes
248-523-5
27554-26-3
Repr. 1B
210-088-4
605-50-5
Repr. 1B
yes
203-560-6
108-20-3
Flam. Liq. 2; STOT SE 3
203-558-5
108-18-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1B
211-617-1
674-82-8
Flam. Liq. 3; Acute Tox. 4
203-326-3
105-74-8
Org. Perox. D
REACTIVE ORANGE F-64 258 FW
401-010-1
106027-83-2
Skin Sens. 1
BLUE GS 1259 R5
407-230-4
126637-70-5
Acute Tox. 4; Skin Sens. 1
204-076-8
115-26-4
Acute Tox. 1; Acute Tox. 2
262-784-2
61432-55-1
Acute Tox. 4
233-307-5
10112-91-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
215-629-8
1335-31-5
Expl. 1.1; Acute Tox. 3; STOT RE 2
256-625-6
50563-36-5
Acute Tox. 4; Skin Sens. 1
605-329-9
163515-14-8
Acute Tox. 4; Skin Sens. 1
200-480-3
60-51-5
Acute Tox. 4
432-310-0
617-55-0
Flam. Liq. 3; Eye Dam. 1; Skin Sens. 1
C.I. DISPERSE BLUE 356
400-460-6
118578-14-6
Skin Sens. 1
620-379-1
3254-63-5
Acute Tox. 1; Acute Tox. 2
210-478-4
616-38-6
Flam. Liq. 2
210-871-0
624-92-0
Flam. Liq. 2; Acute Tox. 3; STOT SE 3; STOT SE 1; Eye Irrit. 2; Skin Sens. 1
204-065-8
115-10-6
Flam. Gas 1; Press. Gas
201-058-1
77-78-1
Carc. 1B; Muta. 2; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
yes
432-860-1
255387-46-3
Skin Sens. 1
201-208-6
79-44-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-901-0
75-78-5
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
203-508-2
107-64-2
Eye Dam. 1
SUMQUAT 6040
404-050-8
123312-54-9
Eye Irrit. 2
301-323-2
93983-68-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
209-805-3
593-74-8
Acute Tox. 2; Acute Tox. 1; STOT RE 2
200-549-8
62-75-9
Carc. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
236-412-4
13360-57-1
Carc. 1B; Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
212-039-2
753-73-1
Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; Skin Corr. 1B
208-884-1
544-97-8
Pyr. Liq. 1; Water-react. 1; Skin Corr. 1B
215-993-8
1468-37-7
Acute Tox. 4
604-712-8
149961-52-4
Carc. 2; Repr. 2; Acute Tox. 4
205-042-5
131-89-5
Acute Tox. 3
234-494-6
12007-01-1
Carc. 1A; STOT RE 1; Skin Sens. 1
238-426-6
14448-18-1
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
238-946-3
14874-78-3
Carc. 1A; STOT RE 1; Skin Sens. 1
237-411-1
13775-54-7
Carc. 1A; STOT RE 1; Skin Sens. 1

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