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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 10 May 2024. Database contains 4753 unique substances/entries.
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DAM 520
413-440-7
112006-75-4
Skin Sens. 1
223-346-6
3846-71-7
yes
CG 25-369; IRGACURE 369; TK 11-319
404-360-3
119313-12-1
Repr. 1B
yes
CITROWANIL B
407-870-4
97384-48-0
Acute Tox. 4
EF-40
406-110-9
35950-52-8
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
DEBROPOL
407-030-7
24403-04-1
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
429-430-0
444-14-4
Acute Tox. 4
426-540-0
2973-59-3
Skin Sens. 1
430-470-6
2065-75-0
Acute Tox. 4; Eye Dam. 1
200-855-1
75-26-3
Flam. Liq. 2; Repr. 1A; STOT RE 2
433-360-6
34036-80-1
STOT RE 2; Skin Sens. 1
203-905-0
111-76-2
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
203-933-3
112-07-2
Acute Tox. 4
SR 48001 A
424-560-4
151257-01-1
Acute Tox. 4; Eye Irrit. 2
C11-NEODIAMINE
412-700-7
137605-95-9
Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
2-BUTYL-4-CHLORO-5-FORMYLIMIDAZOLE; BCFI
410-260-0
83857-96-9
Skin Sens. 1
425-150-8
94723-86-1
Repr. 1B; Acute Tox. 4; Skin Sens. 1
201-174-2
79-07-2
Repr. 2; Acute Tox. 3; Skin Sens. 1
201-864-3
88-88-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 1
424-520-6
65753-47-1
Acute Tox. 3; STOT RE 1; Skin Corr. 1B
2-CHLORO-4,5-DIFLUORO BENZOIC ACID; BA-6; CDFBA
405-380-5
110877-64-0
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
2-CHLOR-4-METHYLSULFONYLBENZOESÄURE; CMSBA
406-520-8
53250-83-2
Eye Dam. 1
427-020-6
141772-37-4
STOT RE 2; Skin Sens. 1
204-502-2
121-87-9
Acute Tox. 4
2-CHLORO-5-CHLOROMETHYLTHIAZOLE
429-830-5
105827-91-6
Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1

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