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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 23 February 2024. Database contains 4753 unique substances/entries.
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442-650-1
37296-97-2
STOT RE 2
422-610-1
-
Eye Dam. 1
BLACK UL 1253
417-280-9
30785-74-1
Eye Dam. 1
BLACK JR 578
419-230-1
-
Skin Sens. 1
432-140-7
110235-47-7
Carc. 2
GR138766X
415-670-3
78850-37-0
Eye Dam. 1
445-990-9
376588-17-9
Skin Sens. 1
HALOXYFOP R-(+)-ME HERBICIDAL CHEMICAL
406-250-0
72619-32-0
Acute Tox. 4
DHPPME; MAK-ME; MEHPOPS; R-MAQ-ME
411-950-4
96562-58-2
Eye Dam. 1
432-350-9
81752-87-6
Skin Irrit. 2
2-NITROBENZYLIDENE METHYL ESTER; BAY O 2787
400-650-9
39562-27-1
Skin Sens. 1
BM
405-270-7
39562-17-9
Skin Sens. 1
442-860-3
87333-22-0
Skin Sens. 1
DISPERSE RED CLA 282
416-240-8
155522-12-6
Skin Sens. 1
JE 127
421-220-7
144740-59-0
Skin Sens. 1
LUGALVAN ES 9571
420-940-9
15768-07-7
Eye Irrit. 2; Skin Irrit. 2
443-120-2
393509-79-0
Eye Dam. 1
MEFAT
404-130-2
105560-93-8
Eye Dam. 1; Skin Sens. 1
G 18-1108
403-270-1
6386-39-6
Acute Tox. 4
D,L-ESTER
411-040-7
97101-46-7
Acute Tox. 4; Skin Sens. 1
431-720-7
90886-53-6
Skin Corr. 1B; Acute Tox. 4
425-190-6
119916-05-1
STOT RE 2
F7641; MTSI
410-550-7
79277-18-2
STOT RE 2; Resp. Sens. 1; Skin Sens. 1
A5546
402-050-2
59337-93-8
Skin Sens. 1
BROMBENZOAT; BROMOBENZOATE
410-310-1
70264-94-7
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
MAT 9460
414-080-3
117291-73-3
Acute Tox. 4
MAGME(R) 200 MONOMER
403-230-3
77402-05-2
Carc. 1B; Muta. 1B; Skin Corr. 1B; Skin Sens. 1
MAGME 100 MONOMEER
401-890-7
77402-03-0
Carc. 1B; Muta. 1B; Acute Tox. 4; Eye Irrit. 2
FAT 40'489
413-040-2
149850-30-6
Skin Sens. 1
414-460-9
105726-67-8
Acute Tox. 4
METHFAT
420-670-1
37443-42-8
Eye Dam. 1
F5384
401-340-6
83055-99-6
Skin Sens. 1
N 5297
419-010-5
112941-26-1
Acute Tox. 4; Eye Irrit. 2
BETA-METHOXYACRYLSÄURE METHYLESTER
412-900-4
5788-17-0
Skin Sens. 1
435-500-1
152460-07-6
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
429-320-2
24748-23-0
Org. Perox. B; Asp. Tox. 1; Skin Irrit. 2; Skin Sens. 1
METHYL-TPP-CHLORID; MTPP-CHLORID
418-400-2
1031-15-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
410-240-1
139528-85-1
Carc. 2; STOT RE 2
NUPORE G45-10
420-480-9
158570-99-1
Skin Irrit. 2; Skin Sens. 1
ICI204636 HYDROGEN FUMARATE
415-180-1
773058-82-5
Acute Tox. 4; Eye Dam. 1
Z-22
415-880-5
779343-34-9
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
429-570-2
213990-58-0
Skin Sens. 1
SYSTHANE TECHNICAL
410-400-0
88671-89-0
Repr. 2; Acute Tox. 4; Eye Irrit. 2
435-860-1
214417-91-1
Skin Sens. 1
429-380-1
133336-92-2
Skin Sens. 1
445-760-8
-
Eye Dam. 1; Resp. Sens. 1
435-010-8
26157-73-3
Muta. 2
LUPRAGEN VP 9159
401-660-6
1000-78-8
Skin Irrit. 2; Skin Sens. 1
BMS 208143-01; BTHC
429-670-6
105996-54-1
Eye Dam. 1; Skin Sens. 1
H-603
404-790-1
66710-66-5
Eye Dam. 1; Skin Sens. 1

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