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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 23 May 2024. Database contains 4753 unique substances/entries.
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MR-7 B; MR-8 B2; MR-S2
411-290-7
131538-00-6
Acute Tox. 4; STOT RE 2
200-026-4
50-31-7
Acute Tox. 4
211-838-3
700-13-0
Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
255-853-3
42498-58-8
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
CIN 10096132; MTI
407-630-9
82633-79-2
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
2,3,5,6-TETRAFLUROROBENZOIC ACID; SUBSTANCE TFBA
416-800-1
652-18-6
Skin Irrit. 2; Eye Dam. 1
-
1065124-65-3
Acute Tox. 4; STOT SE 2
-
240494-71-7
Acute Tox. 4; Acute Tox. 3; STOT SE 1; STOT RE 2
209-292-6
565-75-3
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,3,4-TRIFLUORANILIN
407-170-9
3862-73-5
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
219-397-9
2431-50-7
Carc. 2; Acute Tox. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-402-8
58-90-2
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2
2,3,4,5-TETRACHLORBENZOYLCHLORID
406-760-3
42221-52-3
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
209-207-2
560-21-4
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
218-173-8
2062-98-8
yes
236-236-8
13252-13-6
yes
METHYL ETHYL THIAZOLIDINE
404-500-3
694-64-4
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
218-741-5
2223-82-7
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
207-343-7
463-82-1
Flam. Gas 1; Press. Gas
209-680-5
590-35-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-689-4
590-73-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
200-906-8
75-83-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
2,3-ISOPROPYLIDENE DIOXYPHENOL
400-900-7
22961-82-6
Eye Dam. 1
ROMILAT
415-610-6
104468-21-5
Skin Irrit. 2
N,N DIMETHYL DIETHOXY-2,2 ACETAMIDE
449-950-1
34640-92-1
Eye Irrit. 2
-
7076-53-1
Acute Tox. 3
426-850-6
2032-75-9
Flam. Liq. 3; Skin Corr. 1A; Acute Tox. 4; Skin Sens. 1
PERMACHEM N21
412-380-9
69094-18-4
Expl. 1.1; Carc. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1A; Skin Sens. 1
430-580-4
-
Skin Irrit. 2
DMBA
424-090-1
10097-02-6
Eye Dam. 1
221-967-7
3296-90-0
Carc. 1B; Muta. 1B
239-701-3
15625-89-5
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
CYASORB(R) UV-3638 LIGHT STABILISER
418-280-1
18600-59-4
Skin Sens. 1
FR-1034
408-020-5
109678-33-3
Skin Sens. 1
208-759-1
540-84-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
241-001-8
16938-22-0
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
KHUSINIL
422-580-8
75490-39-0
Acute Tox. 4
209-266-4
564-02-3
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
209-855-6
594-82-1
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
203-874-3
111-48-8
Eye Irrit. 2
223-791-6
4074-88-8
Acute Tox. 3; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
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
200-733-8
70-30-4
Acute Tox. 3
203-865-4
111-40-0
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
203-868-0
111-42-2
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
427-180-7
239446-62-9
Acute Tox. 4; Skin Sens. 1
229-962-1
6864-37-5
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A
201-132-3
78-67-1
Self-react. C; Acute Tox. 4
202-918-9
101-14-4
Carc. 1B; Acute Tox. 4
yes

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