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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 14 June 2024. Database contains 4753 unique substances/entries.
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429-270-1
136210-30-5
Skin Sens. 1
201-083-8
78-10-4
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
201-075-4
78-00-2
yes
230-625-6
7226-23-5
Repr. 2; Acute Tox. 4; Eye Dam. 1
202-625-6
97-99-4
Repr. 1B; Eye Irrit. 2
CIS/TRANS-TIMO; FLOROL; FLOROSA
405-040-6
63500-71-0
Eye Irrit. 2
251-823-9
34090-76-1
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
203-726-8
109-99-9
Flam. Liq. 2; Carc. 2; Eye Irrit. 2; STOT SE 3
203-239-0
104-80-3
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
234-290-7
11070-44-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
247-570-9
26266-63-7
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
203-728-9
110-01-0
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
204-783-1
126-33-0
Acute Tox. 4
THTPA
407-330-8
61571-06-0
Repr. 1B; Eye Dam. 1
428-070-1
91788-83-9
STOT RE 1; Acute Tox. 4
432-770-2
139189-30-3
Skin Sens. 1
SUBSTANCE TP-415; SUBSTANZ TP-415; TP-415
404-760-8
117342-25-3
Acute Tox. 3; Eye Dam. 1
DIRECT YELLOW 86 TETRAMETHYLAMMONIUM SALT; YELLOW DYE FOR PAINTJET PRINT CARTRIDGE
405-950-3
131013-83-7
Acute Tox. 3
FOOD BLACK 2, TETRAMETHYLAMMONIUM SALT
405-170-3
116340-05-7
Acute Tox. 3; Skin Sens. 1
TP-302
404-860-1
116810-46-9
Flam. Sol. 1; Eye Dam. 1
235-380-9
12202-17-4
yes
440-460-3
252579-81-0
Eye Irrit. 2
FOOD BLACK 2, LITHIUM SALT
405-150-4
106028-58-4
Skin Sens. 1
231-711-6
7696-12-0
Carc. 2; Acute Tox. 4; STOT SE 2
TMAP
416-900-5
79723-02-7
Acute Tox. 3; STOT RE 2
213-979-6
1070-70-8
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
202-605-7
97-74-5
Acute Tox. 4; Skin Sens. 1
215-245-0
1314-85-8
Flam. Sol. 2; Water-react. 1; Acute Tox. 4
1291-F; FUCD-4
405-240-3
160683-19-2
Skin Sens. 1
430-390-1
845730-14-5
Acute Tox. 4
430-630-5
10596-22-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
BRILLANTGREEN K-RWA 6083; BRILLIANT GREEN K-RWA 6083
410-160-7
148732-74-5
Eye Irrit. 2; Skin Sens. 1
BLEU REACTIF TZ 3533; BLEU REACTIVE TZ 3533; FAT 41'017/A; REACTIVE BLUE TZ 3533
411-240-4
143683-23-2
Skin Sens. 1
BLEU DIOXAZINA ST 7005; BLEU DIOXAZINE ST 7005; DIOXAZIN BLAU ST 7005; DIOXAZINE BLUE ST 7005
402-590-9
109125-56-6
Eye Dam. 1
432-550-6
243858-01-7
Eye Dam. 1
C.I. REACTIVE BROWN 44
400-430-2
95078-21-0
Skin Sens. 1
AMARELO INDOSOL SF-2RL; INDOSOL GELB SF-2RL; INDOSOL YELLOW SF-2RL; JAUNE INDOSOL SF-2RL; JAUNE WK 1913; SOLAR GOLDEN YELLOW R; YELLOW WK 1913
400-010-9
81898-60-4
Skin Sens. 1
220-012-1
2602-46-2
Carc. 1B; Repr. 2
429-230-3
371921-41-4
Eye Dam. 1
AZO MONOCHLOROTRIAZINYL REACTIVE DYE; PROCION RED PX-6B COLOUR; SUBSTANCE S161057
415-400-4
148878-22-2
Eye Dam. 1; Skin Sens. 1
BLEU MARINE DRIMARENE X-GN PKT; BLEU MARINE X-VT 4046; DRIMAREN MARINEBLAU X-GN PKT; DRIMAREN NAVY X-GN PKT; NAVY BLUE X-VT 4046
400-510-7
85665-98-1
Eye Dam. 1; Skin Sens. 1
BLEU REACTIF 238; BLEU REATTIVO 238; C.I. REACTIVE BLUE 238; DISAZO MARINE TZ 2646; MARINE DIAZO TZ 2646; REACTIVE BLUE 238
404-320-5
116889-78-2
Skin Sens. 1
REACTIVE RED 202 (ESTER)
413-070-6
1379676-82-0
Skin Sens. 1
C.I. REACTIVE RED 219
400-130-1
149057-72-7
Resp. Sens. 1
REACTIVE RED SR 6947; ROUGE REACTIF SR 6947
411-540-5
130201-57-9
Eye Dam. 1; Skin Sens. 1
C.I. REACTIVE RED 220; CIBACRON-RED F-2G; CIBACRON-ROT F-2G; REACTIVE RED 220; ROSSO REATTIVO 220; ROUGE REACTIF 220
400-790-0
85665-97-0
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
NAVY 14 05 711
411-470-5
141048-13-7
Skin Sens. 1
RED ULK 1640
420-350-1
172277-97-3
Eye Dam. 1
200-573-9
64-02-8
Acute Tox. 4; Eye Dam. 1
231-138-1
7440-28-0
Acute Tox. 2; STOT RE 2

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