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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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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423-750-4
-
Eye Irrit. 2
T-69
414-770-4
140698-96-0
Self-react. C; Carc. 2
CASSIFFIX
422-040-1
426218-78-2
Eye Irrit. 2; Skin Irrit. 2
427-050-1
170016-25-8
Repr. 2; Skin Irrit. 2; Skin Sens. 1
-
8069-76-9
Acute Tox. 4
34 DIAZO
417-080-1
-
Self-react. D; Skin Sens. 1
NEOCASPIRENE
412-460-3
89079-92-5
Skin Irrit. 2
FORMYLTRICYCLODECEN, EXO
410-480-7
-
Skin Sens. 1
431-440-5
-
Eye Dam. 1
DISPERSIONSROT 2754
411-880-4
-
Skin Sens. 1
435-440-6
-
Eye Dam. 1
442-290-5
457624-86-1
Eye Dam. 1
440-510-4
-
Eye Dam. 1; Skin Sens. 1
ROT Y; RUBINOT Y; RUBINROT Y
408-240-1
-
Acute Tox. 4
ACRYLSKUM; T-2816 FOAMER
407-810-7
-
STOT RE 2
425-910-9
32480-08-3
Skin Irrit. 2
432-190-1
182176-52-9
Acute Tox. 4; STOT RE 2; Eye Dam. 1
442-800-6
-
Skin Irrit. 2
UVA RAR 1018
423-520-3
156137-33-6
Skin Sens. 1
MMA-10R
423-670-1
-
Eye Dam. 1; Skin Sens. 1
FLORASANTOL
415-990-3
67739-11-1
Eye Irrit. 2
EUGEWHITE
412-020-0
-
Skin Sens. 1
419-000-0
-
Skin Sens. 1
SPE 93279
414-420-0
-
Eye Dam. 1
VIKOFLEX 9080
414-890-7
71302-79-9
Skin Sens. 1
428-050-2
-
Skin Sens. 1
AF-376
407-740-7
138427-56-2
Skin Irrit. 2; Skin Sens. 1
RED E190
411-560-4
-
STOT RE 1; Skin Sens. 1
F1 MINERAL FLOTATION COLLECTOR (40% HTEA.HCL)
405-720-2
-
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
PIGMENTADDITIV P
411-310-4
-
Eye Dam. 1
429-590-1
-
Skin Sens. 1
442-300-8
-
Skin Sens. 1
EXPERIMENTAL CROSSLINKER S17762-80(S); MELAMINE BASED CROSSLINKER (MBC); TACT
420-390-1
187547-46-2
Skin Sens. 1
HIGHLINK DM
421-890-0
51673-84-8
Skin Sens. 1
CYASORB UV-3853 LIGHT STABILIZER; DASTIB 845; SANDUVOR 845
415-430-8
86403-32-9
Eye Dam. 1; Skin Sens. 1
429-710-2
-
Self-react. D; Acute Tox. 4
PEROXIMON 180
412-140-3
32144-25-5
Org. Perox. D
419-610-7
171866-24-3
STOT RE 2
Z-19
414-520-4
-
Skin Irrit. 2; Eye Dam. 1
434-330-5
-
Carc. 2; Skin Sens. 1
KEROFLUX ES 3241
406-640-0
136920-07-5
Skin Sens. 1
PEROXIMON S 168 TECHNICALLY PURE
410-840-3
71566-50-2
Org. Perox. C
GA1270; HOE S 4096
407-290-1
-
Eye Dam. 1
430-690-2
52783-21-8
Skin Irrit. 2
426-530-6
-
Skin Irrit. 2
HFR-990
423-180-6
-
STOT RE 2
427-040-5
-
Skin Corr. 1B
BLENDUR I VP KU 3-4519
421-550-1
-
Carc. 1B; Repr. 1B; Skin Sens. 1
433-640-8
-
Pyr. Sol. 1
442-480-8
-
Org. Perox. C; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1

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