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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 16 April 2024. Database contains 4753 unique substances/entries.
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201-114-5
78-40-0
Acute Tox. 4
200-929-3
76-05-1
Acute Tox. 4; Skin Corr. 1A
231-205-5
7446-27-7
Repr. 1A; STOT RE 2
-
74646-29-0
Carc. 1A; STOT RE 1; Skin Sens. 1
-
7276-58-6
Acute Tox. 4
231-170-6
7440-61-1
Acute Tox. 2; STOT RE 2
200-831-0
75-01-4
Press. Gas; Flam. Gas 1; Carc. 1A
231-592-0
7646-85-7
Acute Tox. 4; Skin Corr. 1B
231-175-3
7440-66-6
Water-react. 1; Pyr. Sol. 1
231-793-3
7733-02-0
Acute Tox. 4; Eye Dam. 1
616-096-8
7446-19-7
Acute Tox. 4; Eye Dam. 1
231-176-9
7440-67-7
Water-react. 1; Pyr. Sol. 1
231-176-9
7440-67-7
Self-heat. 1
SQ 26999
412-170-7
83623-61-4
STOT RE 2; Eye Dam. 1; Skin Sens. 1
433-520-5
82911-69-1
Acute Tox. 4; Skin Sens. 1
DWS
404-940-6
86608-70-0
Acute Tox. 4; Eye Dam. 1; STOT RE 2
284-351-7
84852-39-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
287-470-2
85508-45-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
201-501-9
83-79-4
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
443-560-5
88784-33-2
Eye Irrit. 2
SULPHONAMIDO-ANILINE
406-010-5
88918-84-7
Eye Dam. 1; Skin Sens. 1
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
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
284-348-0
84852-36-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
285-909-2
85166-19-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
287-471-8
85508-46-9
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
287-592-6
85551-28-6
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
284-347-5
84852-35-7
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
445-750-3
839705-03-2
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
811-718-6
86347-14-0
Acute Tox. 2; STOT SE 3; STOT SE 1; STOT RE 1
C.I. REAKTIV-BLAU 216; KAYACELON REACT BLUE CN-BL; KAYACELON REAKT-BLAU CN-BL; UBCNBL
404-670-9
89797-01-3
Skin Sens. 1
430-100-3
86978-24-7
Acute Tox. 4
281-291-3
83918-57-4
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
281-291-3
83918-57-4
Acute Tox. 4; Skin Sens. 1
212-557-9
826-62-0
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
201-605-4
85-43-8
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
284-032-2
84777-06-0
Repr. 1B
yes
DCEMH
401-570-7
89415-87-2
Ox. Sol. 1; Acute Tox. 3; Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
4-(4-BUTYLCYCLOHEXYL)-ACETOPHENON
427-320-7
83626-30-6
Skin Sens. 1
GM 102 E
411-370-1
82857-68-9
Acute Tox. 3; Eye Dam. 1
201-800-4
88-12-0
Carc. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Eye Dam. 1
282-263-3
84145-37-9
Flam. Liq. 3
EPIKOTE YX4000; EPIKOTE YX4000H; YX-4000
413-900-7
85954-11-6
Carc. 2; Skin Sens. 1
CIN 10096132; MTI
407-630-9
82633-79-2
Acute Tox. 3; Eye Dam. 1; Skin Sens. 1
201-795-9
88-06-2
Carc. 2; Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
201-865-9
88-89-1
Expl. 1.1; Acute Tox. 3
201-436-6
82-71-3
Expl. 1.1; Acute Tox. 4
428-390-1
86393-34-2
STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1

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