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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 29 March 2024. Database contains 4753 unique substances/entries.
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17-KETOBROMOHYDRINE
419-790-7
4229-69-0
Skin Sens. 1
PHOTOAMORCEUR 22074; RHODORSIL PHOTOINITIATOR 2074; TEPBI
422-960-3
178233-72-2
Acute Tox. 4; STOT RE 2
SULPHONAMIDO-ANILINE
406-010-5
88918-84-7
Eye Dam. 1; Skin Sens. 1
247-162-0
25646-77-9
Acute Tox. 3; STOT RE 2; Skin Sens. 1
SILANEOPHAN
405-020-7
105024-66-6
Repr. 1B
SULPHAZINE
406-090-1
81880-96-8
Muta. 2; Acute Tox. 3; STOT RE 1; Skin Sens. 1
420-450-5
86552-32-1
Carc. 2; Eye Dam. 1
428-690-2
1668-86-6
Acute Tox. 4; Eye Irrit. 2
425-930-8
151213-39-7
Skin Corr. 1B; Acute Tox. 4; STOT RE 2
2691; CARTASOL BRILLANT SCHARLACH K-2GL KONZ.; CARTASOL BRILLANTSCHARLACH K-2GL FLÜSSIG (ZUBEREITUNG); CARTASOL BRILLANTSCHARLACH K-2GL GRANULAT (ZUBEREITUNG); CARTASOL BRILLIANT SCARLET K-2GL; CARTASOL BRILLIANT SCARLET K-2GL CONC.
402-060-7
108225-03-2
Carc. 1B; Eye Dam. 1
423-260-0
100988-63-4
Muta. 2; Skin Sens. 1
433-490-3
6563-83-3
Skin Sens. 1
E.M.A.
406-790-7
26116-56-3
Eye Dam. 1
244-445-0
21564-17-0
Acute Tox. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
(2-BENZOTHIAZOLYLTHIO)BERNSTEINSÄURE; BTTBS; HALOX 650; IRGACOR 252
401-450-4
95154-01-1
Skin Sens. 1
OA 8523
402-460-1
-
Skin Irrit. 2; Skin Sens. 1
616-221-6
7541-49-3
Skin Irrit. 2
204-647-1
123-73-9
Flam. Liq. 2; Muta. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
227-678-2
5932-68-3
Skin Sens. 1A
HEXAROSE
421-370-3
3681-73-0
Skin Irrit. 2
DPP
410-980-5
112704-51-5
Eye Irrit. 2; Skin Sens. 1
PYRIDYLACROLEIN
426-330-9
177964-68-0
Eye Irrit. 2; Skin Sens. 1
CP-166,221
428-010-4
82413-20-5
Carc. 2; Repr. 1B; Skin Sens. 1
429-900-5
82356-51-2
Skin Sens. 1
210-855-3
624-64-6
Flam. Gas 1; Press. Gas

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