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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 26 April 2024. Database contains 4753 unique substances/entries.
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CASSIFFIX
422-040-1
426218-78-2
Eye Irrit. 2; Skin Irrit. 2
T-69
414-770-4
140698-96-0
Self-react. C; Carc. 2
423-750-4
-
Eye Irrit. 2
R 7623 TECHNICAL
403-250-2
-
Carc. 2; Repr. 1B; Acute Tox. 4
RAS-5 1000 CPS; RAS-5 400 CPS; RAS-5 4000 CPS
417-470-1
-
Muta. 2; Skin Sens. 1
451-440-9
586372-44-3
Eye Dam. 1
427-730-6
202420-04-0
Skin Corr. 1B
T-4240 FLUOROCHEMICAL URETHANE DERIVATIVE
413-640-4
-
STOT RE 2
BONJET BLACK 817
418-230-9
163879-69-4
Expl. 1.3; Repr. 2; STOT RE 2; Skin Sens. 1
611-341-5
55965-84-9
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1C; Eye Dam. 1; Skin Sens. 1A
MONO 442
412-260-6
52658-19-2
Eye Irrit. 2; Skin Sens. 1
INTERMEDIAIRE AR HT 3728
410-065-0
-
Skin Sens. 1
DP 15
410-640-6
-
Skin Irrit. 2; Eye Dam. 1
AMMONIUM DIAS
407-320-3
-
Skin Irrit. 2; Eye Dam. 1
A-88820.605
414-810-0
-
STOT RE 2; Eye Dam. 1
MCP 455
406-240-6
-
Flam. Liq. 3; Skin Corr. 1B
MDI
406-550-1
-
Skin Sens. 1
C.I. DIRECT VIOLET 9; VIOLET PERGASOL EN LIQUIDE
406-910-8
124649-82-7
Acute Tox. 4
422-920-5
-
STOT RE 2
417-050-8
151006-58-5
Acute Tox. 4
DOW CORNING (R) 4-2920 INTERMEDIATE
406-930-7
96-29-7
STOT RE 1; Skin Sens. 1
SP 7053
415-930-6
-
Repr. 2; Skin Sens. 1
SP 7077
430-180-1
-
Skin Irrit. 2
429-990-6
-
Eye Dam. 1; Skin Sens. 1
VESTAGON EP S 270
411-830-1
114765-88-7
Eye Dam. 1; Skin Sens. 1
CAMONAL
426-130-1
166301-21-9
Skin Irrit. 2
422-260-8
20701-68-2
Eye Dam. 1
NEWLON AM-92I
407-490-9
-
Acute Tox. 4; Skin Corr. 1B
MUGETANOL
407-640-3
63767-86-2
Eye Irrit. 2; Skin Irrit. 2
OLOA 224 (OIL FREE)
420-470-4
-
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
427-140-9
-
Carc. 2
435-960-3
-
Carc. 1B; Muta. 1B; Skin Sens. 1
AZUL MARINHO 018112; BLEU MARINE 018112; NAVY 018112; NAVY BLUE 018112
405-665-4
118685-33-9
Skin Sens. 1
DYE K
402-660-9
-
Repr. 1B
PACIFIED REACTIVE BLACK 31
423-940-7
85585-91-7
Eye Dam. 1
426-840-1
-
Eye Dam. 1
DOWFAX (R) DRY HYDROTROPE POWDER
429-650-7
147732-60-3
Eye Irrit. 2
PRIAZUL LAUROYL LACTYLATE; PRICARE LAURYL LACTYLATE (1:1.5)
412-590-0
58856-63-6
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
PRICARE
411-860-5
-
Skin Sens. 1
VP SANDUVOR 3052 LIQUIDE
405-670-1
119530-69-7
Acute Tox. 4; STOT RE 2; Skin Corr. 1B
434-420-4
-
Skin Irrit. 2; Eye Dam. 1
427-090-8
116044-44-1
Skin Sens. 1
FRUITATE
407-520-0
80657-64-3
Skin Irrit. 2
CYANEX (R) EXTRACTANT; CYANEX 923 EXTRACTANT
403-470-9
-
Skin Corr. 1B
BONTRON E-88
406-890-0
130296-87-6
Acute Tox. 4
MCP 938
410-720-0
141847-13-4
Eye Dam. 1
435-450-0
5460-63-9
Skin Sens. 1
424-290-7
188070-47-5
Skin Sens. 1
434-240-6
-
Skin Sens. 1
REACTIVE YELLOW FC 75560
419-450-8
-
Skin Sens. 1

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