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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 18 April 2024. Database contains 4753 unique substances/entries.
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TP-302
404-860-1
116810-46-9
Flam. Sol. 1; Eye Dam. 1
235-380-9
12202-17-4
yes
FOOD BLACK 2, LITHIUM SALT
405-150-4
106028-58-4
Skin Sens. 1
213-979-6
1070-70-8
Acute Tox. 4; Skin Corr. 1B; 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
430-630-5
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
AZO MONOCHLOROTRIAZINYL REACTIVE DYE; PROCION RED PX-6B COLOUR; SUBSTANCE S161057
415-400-4
148878-22-2
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
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
601-147-9
111988-49-9
Carc. 2; Repr. 1B; Acute Tox. 4; Acute Tox. 3; STOT SE 3
428-650-4
153719-23-4
Acute Tox. 4
RT 1766A
404-820-3
164637-97-2
Skin Irrit. 2; Skin Sens. 1
205-286-2
137-26-8
Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
236-675-5
13463-67-7
Carc. 2
203-625-9
108-88-3
Flam. Liq. 2; Repr. 2; Asp. Tox. 1; STOT RE 2; Skin Irrit. 2; STOT SE 3
204-854-7
127-65-1
Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1
FC4010
417-290-3
147086-81-5
Acute Tox. 4
238-009-9
14166-21-3
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
yes
205-860-2
156-60-5
Flam. Liq. 2; Acute Tox. 4
443-150-6
101226-85-1
Flam. Liq. 3
405-060-5
118712-89-3
Skin Irrit. 2
BASIC YELLOW 105; C.I. BASIC YELLOW 105
405-860-4
121315-16-0
Skin Sens. 1
620-368-1
1031-47-6
Acute Tox. 1; Acute Tox. 2
401-190-1
101200-48-0
STOT RE 2; Skin Sens. 1
204-800-2
126-73-8
Carc. 2; Acute Tox. 4; Skin Irrit. 2
D 27-046
413-520-1
125792-14-5
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
233-042-5
10025-78-2
Flam. Liq. 1; Pyr. Liq. 1; Acute Tox. 4; Skin Corr. 1A
215-548-8
1330-78-5
STOT SE 1
215-548-8
1330-78-5
Acute Tox. 4
DYNASILAN BH N; DYNASILAN BSM 100 N; DYNASILAN NH 42
402-810-3
17980-47-1
Skin Irrit. 2
TRIETHYLARSENAT; TRIETHYLARSENATE; TRIETHYLARSENATE (TEASAT)
427-700-2
15606-95-8
Carc. 1A; Acute Tox. 3
yes
204-469-4
121-44-8
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
215-812-2
1420-06-0
Acute Tox. 4
604-237-6
141517-21-7
Skin Sens. 1
216-428-8
1582-09-8
Carc. 2; Skin Sens. 1
603-146-9
126535-15-7
Carc. 2
235-688-3
12519-85-6
Carc. 1A; STOT RE 1; Skin Sens. 1
215-290-6
1319-46-6
yes
235-252-2
12141-20-7
yes
ACID BLUE FC 77890
414-290-5
149564-65-8
Acute Tox. 4
IJA-286; IJBK-286; IJBK-286-LI
403-650-7
117409-78-6
Expl. 1.3
204-468-9
121-43-7
Flam. Liq. 3; Acute Tox. 4

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