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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 21 June 2024. Database contains 4753 unique substances/entries.
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204-318-2
119-38-0
Acute Tox. 1; Acute Tox. 2
203-539-1
107-98-2
Flam. Liq. 3; STOT SE 3
METHOXYISOPROPYLAMINE
422-550-4
37143-54-7
Flam. Liq. 2; Skin Corr. 1B; Acute Tox. 4
200-730-1
70-25-7
Carc. 1B; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
431-180-2
5271-27-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
424-160-1
139481-22-4
Acute Tox. 4
423-960-6
139756-01-7
Acute Tox. 4; STOT RE 2
210-946-8
626-38-0
Flam. Liq. 3
210-484-7
616-47-7
Acute Tox. 4; Skin Corr. 1B
243-105-9
19485-03-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
205-138-7
134-32-7
Acute Tox. 4
201-969-4
90-15-3
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
203-544-9
108-03-2
Flam. Liq. 3; Acute Tox. 4
N-N-OCTYLCAPROLACTAM; N-OCTYLCAPROLACTAME
420-040-6
59227-88-2
Skin Corr. 1B; Skin Sens. 1
200-752-1
71-41-0
Flam. Liq. 3; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
TUPH
424-620-1
13909-63-2
Acute Tox. 4; STOT RE 2
202-155-1
92-43-3
Acute Tox. 4
202-706-6
618-36-0;98-84-0
Acute Tox. 4; Skin Corr. 1B
202-706-6
618-36-0;98-84-0
Acute Tox. 4; Skin Corr. 1B
ARCOSOLV PTB; ARCOSOLV(R) PTB
406-180-0
57018-52-7
Flam. Liq. 3; Eye Dam. 1
201-800-4
88-12-0
Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Eye Dam. 1
448-720-8
363138-44-7
Acute Tox. 4; Eye Dam. 1
432-840-2
220926-97-6
Acute Tox. 4
424-370-1
125496-22-2
Skin Irrit. 2; Skin Sens. 1
BLEU DISPERSE 370; BLEU DISPERSO 370; BLEU LIP 6994; C.I. DISPERSE BLUE 370; DISPERS BLAU 370; DISPERSE BLUE 370
403-010-7
106359-94-8
Skin Sens. 1

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