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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 22 April 2024. Database contains 4753 unique substances/entries.
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427-040-5
-
Skin Corr. 1B
HFR-990
423-180-6
-
STOT RE 2
426-530-6
-
Skin Irrit. 2
430-690-2
52783-21-8
Skin Irrit. 2
GA1270; HOE S 4096
407-290-1
-
Eye Dam. 1
PEROXIMON S 168 TECHNICALLY PURE
410-840-3
71566-50-2
Org. Perox. C
KEROFLUX ES 3241
406-640-0
136920-07-5
Skin Sens. 1
434-330-5
-
Carc. 2; Skin Sens. 1
Z-19
414-520-4
-
Skin Irrit. 2; Eye Dam. 1
419-610-7
171866-24-3
STOT RE 2
PEROXIMON 180
412-140-3
32144-25-5
Org. Perox. D
429-710-2
-
Self-react. D; Acute Tox. 4
CYASORB UV-3853 LIGHT STABILIZER; DASTIB 845; SANDUVOR 845
415-430-8
86403-32-9
Eye Dam. 1; Skin Sens. 1
HIGHLINK DM
421-890-0
51673-84-8
Skin Sens. 1
EXPERIMENTAL CROSSLINKER S17762-80(S); MELAMINE BASED CROSSLINKER (MBC); TACT
420-390-1
187547-46-2
Skin Sens. 1
442-300-8
-
Skin Sens. 1
429-590-1
-
Skin Sens. 1
PIGMENTADDITIV P
411-310-4
-
Eye Dam. 1
F1 MINERAL FLOTATION COLLECTOR (40% HTEA.HCL)
405-720-2
-
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
RED E190
411-560-4
-
STOT RE 1; Skin Sens. 1
AF-376
407-740-7
138427-56-2
Skin Irrit. 2; Skin Sens. 1
428-050-2
-
Skin Sens. 1
VIKOFLEX 9080
414-890-7
71302-79-9
Skin Sens. 1
SPE 93279
414-420-0
-
Eye Dam. 1
419-000-0
-
Skin Sens. 1
EUGEWHITE
412-020-0
-
Skin Sens. 1
FLORASANTOL
415-990-3
67739-11-1
Eye Irrit. 2
MMA-10R
423-670-1
-
Eye Dam. 1; Skin Sens. 1
UVA RAR 1018
423-520-3
156137-33-6
Skin Sens. 1
442-800-6
-
Skin Irrit. 2
432-190-1
182176-52-9
Acute Tox. 4; STOT RE 2; Eye Dam. 1
425-910-9
32480-08-3
Skin Irrit. 2
ACRYLSKUM; T-2816 FOAMER
407-810-7
-
STOT RE 2
ROT Y; RUBINOT Y; RUBINROT Y
408-240-1
-
Acute Tox. 4
440-510-4
-
Eye Dam. 1; Skin Sens. 1
442-290-5
457624-86-1
Eye Dam. 1
435-440-6
-
Eye Dam. 1
DISPERSIONSROT 2754
411-880-4
-
Skin Sens. 1
431-440-5
-
Eye Dam. 1
FORMYLTRICYCLODECEN, EXO
410-480-7
-
Skin Sens. 1
NEOCASPIRENE
412-460-3
89079-92-5
Skin Irrit. 2
34 DIAZO
417-080-1
-
Self-react. D; Skin Sens. 1
427-050-1
170016-25-8
Repr. 2; Skin Irrit. 2; Skin Sens. 1
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

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