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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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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AROCY M-10
405-790-4
101657-77-6
Skin Sens. 1
243-420-1
19900-65-3
Carc. 2; Acute Tox. 4
LONZACURE M-MIPA
415-150-6
16298-38-7
STOT RE 2
LUPRAGEN VP 9199 X
412-840-9
13474-64-1
Acute Tox. 4; STOT RE 2; Skin Corr. 1A
225-863-2
5124-30-1
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
212-658-8
838-88-0
Carc. 1B; Acute Tox. 4; Skin Sens. 1
yes
202-966-0
101-68-8
Carc. 2; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
431-850-4
7456-68-0
Expl. 1.1; STOT RE 2
DD-63
404-590-4
90884-29-0
Skin Sens. 1
-
-
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
202-977-0
101-80-4
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
yes
HMPSC
403-330-7
24197-34-0
Eye Dam. 1
-
-
Carc. 1B; Acute Tox. 4
205-370-9
139-65-1
Carc. 1B; Acute Tox. 4
421-360-9
148043-73-6
Acute Tox. 4
CARBONATE DE TETRACHLOROETHYLENE
404-060-2
22432-68-4
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
AMINOBUTYRALDEHYDE DIMETHYL ACETAL
407-690-6
19060-15-2
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
TRIOXABICYCLOOCTAN; TRIOXABICYCLOOCTANE
421-750-9
57280-22-5
Eye Irrit. 2; Skin Sens. 1
AP-5
401-720-1
6807-17-6
Repr. 1B; Eye Irrit. 2
yes
264-843-8
64359-81-5
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1; Eye Dam. 1; Skin Sens. 1A
HOMOFARNESYLSÄURE
403-000-2
91853-67-7
Skin Irrit. 2
ORRINIFF
402-520-7
125352-06-9
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
-
-
yes
621-341-7
2315-61-9
yes
205-426-2
140-66-9
Skin Irrit. 2; Eye Dam. 1
yes
423-860-2
56309-94-5
Skin Sens. 1
257-907-1
52427-13-1
yes
ACRYLOYLMORPHOLIN
418-140-1
5117-12-4
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
635-388-6
521947-27-3
yes
WL 125892
402-190-4
113674-95-6
STOT RE 1; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
LICHTSCHUTZMITTEL 1071
413-510-7
147374-67-2
STOT RE 2; Skin Sens. 1
4-ALLYLOXYBENZOESÄURE-(4-METHACRYLOYL)PHENYLESTER
429-000-2
159235-16-2
Skin Sens. 1
MORTRACE ST CONC.
410-600-8
124719-26-2
STOT RE 2; Skin Irrit. 2
635-389-1
186825-36-5
yes
635-391-2
142731-63-3
yes
635-696-0
186825-39-8
yes
CARBODIM
413-120-7
107144-30-9
Acute Tox. 4
250-863-4
31906-04-4
Skin Sens. 1A
MORTRACE SB CONC.
410-610-2
111850-24-9
STOT RE 2; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
JKY-120
405-730-7
51601-57-1
STOT RE 2
426-900-7
203118-12-1
STOT SE 3
431-200-1
208538-34-5
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
4-(4-PROPYLCYCLOHEXYL)-ACETOPHENON
406-700-6
78531-61-0
Skin Sens. 1
425-030-5
159939-85-2
Repr. 2; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
PLAKATROT Z; ROT BN
406-305-9
92952-81-3
Skin Irrit. 2
M.E.M.P.E.
407-940-4
111681-72-2
Eye Dam. 1
PSL 6
411-400-3
102089-33-8
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
ANTHRACHINON BLAU 27 HD
406-057-1
114565-66-1
Carc. 2; Skin Sens. 1
420-220-4
92771-56-7
Skin Sens. 1
CIN 10097929
418-320-8
133467-41-1
Acute Tox. 4

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