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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 19 April 2024. Database contains 4753 unique substances/entries.
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215-125-8
1303-86-2
Repr. 1B
yes
200-824-2
74-95-3
Acute Tox. 4
201-557-4
84-74-2
Repr. 1B
yes
AMINODARONE OXALATE; SR33580A
448-700-9
500791-70-8
STOT RE 2; Eye Dam. 1; Skin Sens. 1
245-152-0
22673-19-4
Repr. 1B; STOT RE 1
yes
211-670-0
683-18-1
Muta. 2; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B
yes
201-039-8
77-58-7
Muta. 2; Repr. 1B; STOT RE 1
DBB
401-040-5
75113-37-0
Repr. 1B; Muta. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
217-635-6
1918-00-9
Acute Tox. 4; Eye Dam. 1
214-787-5
1194-65-6
Acute Tox. 4
202-564-5
97-17-6
Acute Tox. 4
214-118-7
1085-98-9
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
204-210-5
117-80-6
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
SILAN DCS
407-180-3
770722-36-6
Skin Corr. 1A
220-487-5
2782-57-2
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
201-207-0
79-43-6
Skin Corr. 1A
201-199-9
79-36-7
Skin Corr. 1A
620-404-6
7572-29-4
Unst. Expl.; Carc. 2; STOT RE 2
222-583-2
3542-36-7
Repr. 1B; Acute Tox. 2; STOT RE 1
200-838-9
75-09-2
Carc. 2
202-567-1
97-23-4
Acute Tox. 4; Eye Irrit. 2
204-390-5
120-36-5
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
D-2,4-DP; DICHLORPROP-P; DUPLOSAN DP-ACID
403-980-1
15165-67-0
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
200-547-7
62-73-7
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
236-881-5
13530-68-2
yes
246-356-2
24613-89-6
Ox. Sol. 1; Carc. 1B; Skin Corr. 1A; Skin Sens. 1
yes
620-436-0
75736-33-3
Eye Irrit. 2
257-141-8
51338-27-3
Acute Tox. 4; Skin Sens. 1
204-082-0
115-32-2
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
215-572-9
1332-65-6
Acute Tox. 4; Acute Tox. 3
215-270-7
1317-39-1
Acute Tox. 4; Eye Dam. 1
200-632-9
66-76-2
STOT RE 1; Acute Tox. 4
205-494-3
141-66-2
Acute Tox. 2; Acute Tox. 3
201-545-9
84-61-7
Repr. 1B; Skin Sens. 1
yes
202-980-7
101-83-7
Acute Tox. 4; Skin Corr. 1B
221-515-9
3129-91-7
Acute Tox. 4
208-704-1
538-75-0
Acute Tox. 3; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
DCPMS; DYNASYLAN 9415; EURENOR 5023; SAN-30; WACKER SILAN CP2-DIMETHOXY; Z-6228
404-370-8
126990-35-0
Skin Irrit. 2; Eye Dam. 1
230-525-2
7173-51-5
Acute Tox. 4; Skin Corr. 1B
200-484-5
60-57-1
Carc. 2; Acute Tox. 1; Acute Tox. 3; STOT RE 1
274-460-8
70225-14-8
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
-
-
Acute Tox. 4
SIFOSIL; SIFOSIL KONZENTRAT G 96-00 FEST
401-770-4
148324-78-1
Skin Corr. 1B; Acute Tox. 4
200-467-2
60-29-7
Flam. Liq. 1; Acute Tox. 4; STOT SE 3
200-589-6
64-67-5
Carc. 1B; Muta. 1B; Acute Tox. 4; Skin Corr. 1B
yes
DAMA
426-790-0
162208-27-7
Acute Tox. 4; STOT RE 2; Skin Sens. 1
CS 100; SILOXAL
401-160-8
55426-95-4
Water-react. 1; Pyr. Liq. 1; Skin Corr. 1A
431-430-0
103976-28-9
Acute Tox. 4
203-716-3
109-89-7
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
201-798-5
88-10-8
Carc. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2

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