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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 October 2021. Database contains 4812 unique substances/entries.
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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
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
424-620-1
13909-63-2
Acute Tox. 4; STOT RE 2
202-155-1
92-43-3
Acute Tox. 4
210-545-8
618-36-0;98-84-0
Acute Tox. 4; Skin Corr. 1B
210-545-8
618-36-0;98-84-0
Acute Tox. 4; Skin Corr. 1B
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
214-012-0
1072-63-5
Repr. 1B
yes
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
403-010-7
106359-94-8
Skin Sens. 1
405-200-5
104366-25-8
Skin Sens. 1
405-190-2
122371-93-1
Skin Sens. 1
282-263-3
84145-37-9
Flam. Liq. 3
203-872-2
111-46-6
Acute Tox. 4
225-208-0
4719-04-4
Acute Tox. 4; Skin Sens. 1
413-900-7
85954-11-6
Carc. 2; Skin Sens. 1
216-853-9
1680-21-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
203-312-7
105-59-9
Eye Irrit. 2
214-237-4
1116-54-7
Carc. 1B
221-070-0
2997-92-4
Acute Tox. 4; Skin Sens. 1
429-090-3
61551-69-7
Skin Sens. 1
215-979-1
1464-53-5
Carc. 1B; Muta. 1B; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
411-570-9
41481-66-7
Skin Sens. 1
202-918-9
101-14-4
Carc. 1B; Acute Tox. 4
yes
201-132-3
78-67-1
Self-react. C; Acute Tox. 4
229-962-1
6864-37-5
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A
427-180-7
239446-62-9
Acute Tox. 4; Skin Sens. 1
203-868-0
111-42-2
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
203-865-4
111-40-0
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
200-733-8
70-30-4
Acute Tox. 3
219-799-4
2536-05-2
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
223-791-6
4074-88-8
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
203-874-3
111-48-8
Eye Irrit. 2
209-855-6
594-82-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
207-346-3
464-06-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-266-4
564-02-3
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
422-580-8
75490-39-0
Acute Tox. 4
241-001-8
16938-22-0
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
208-759-1
540-84-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
408-020-5
109678-33-3
Skin Sens. 1

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