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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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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BLUE TZ 4312
423-770-3
-
Eye Dam. 1
SCARLET 12 04 262
406-820-9
159317-41-6
Eye Irrit. 2
SÄUREBLAU 82 226
402-500-8
104105-46-6
Eye Dam. 1
BROWN 1612969
407-110-1
480445-87-2
Eye Dam. 1; Skin Sens. 1
237-159-2
13674-87-8
Carc. 2
LEXMARK YELLOW DYE 415; PRISM YELLOW
406-073-9
131013-81-5
Acute Tox. 3
PIGMENTBLAU 1755
403-210-4
108300-90-9
Eye Dam. 1
247-759-6
26523-78-4
Skin Sens. 1
yes
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Phenol, p-sec-nonyl-, phosphite EC / List no: - | CAS no: 106599-06-8
Tris(nonylphenyl) phosphite EC / List no: 247-759-6 | CAS no: 26523-78-4
tris(4-nonylphenyl, branched) phosphite EC / List no: 701-028-2 | CAS no: -
Phenol, 4-nonyl-, phosphite (3:1) EC / List no: 608-492-4 | CAS no: 3050-88-2
Phenol, p-isononyl-, phosphite (3:1) EC / List no: - | CAS no: 31631-13-7
799-976-5
-
yes
213-934-0
1067-53-4
Repr. 1B
204-118-5
115-96-8
Carc. 2; Repr. 1B; Acute Tox. 4
yes
ACETOACETYLORTHOSINIC ACID, A6-SALT
403-760-5
68030-79-5
Skin Sens. 1
-
7276-58-6
Acute Tox. 4
-
-
Acute Tox. 3
TRYPROPYLAMMONIUM DIHYDROGENPHOSPHAT
433-700-3
35687-90-2
Acute Tox. 4
-
-
Acute Tox. 3
442-960-7
332350-93-3
Acute Tox. 3; Eye Dam. 1
202-908-4
101-02-0
Eye Irrit. 2; Skin Irrit. 2
-
-
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
TZ 02508
413-320-4
869-59-0
STOT RE 1; Skin Irrit. 2
-
12137-12-1
Carc. 1A; STOT RE 1; Skin Sens. 1
234-829-6
12035-72-2
Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1
234-495-1
12007-02-2
Carc. 1A; STOT RE 1; Skin Sens. 1
233-844-5
10381-36-9
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
-
74646-29-0
Carc. 1A; STOT RE 1; Skin Sens. 1
236-771-7
13477-70-8
Carc. 1A; STOT RE 1; Skin Sens. 1
-
-
Acute Tox. 2; Acute Tox. 1
257-765-0
52234-82-9
Muta. 2; Eye Dam. 1; Skin Sens. 1
1,3-PDTA; AGENT CHELATANT KODAK NO.1; DISSOLVINE PDZ; HAMPSHIRE PDTA; KODAK CHELATING AGENT NO.1; TRILON R FS
400-400-9
1939-36-2
Acute Tox. 4; Eye Dam. 1
204-468-9
121-43-7
Flam. Liq. 3; Acute Tox. 4
220-449-8
2768-02-7
Skin Sens. 1B
IJA-286; IJBK-286; IJBK-286-LI
403-650-7
117409-78-6
Expl. 1.3
ACID BLUE FC 77890
414-290-5
149564-65-8
Acute Tox. 4
235-252-2
12141-20-7
yes
222-979-5
3687-31-8
yes
231-205-5
7446-27-7
Repr. 1A; STOT RE 2
215-290-6
1319-46-6
yes
235-688-3
12519-85-6
Carc. 1A; STOT RE 1; Skin Sens. 1
603-146-9
126535-15-7
Carc. 2
216-428-8
1582-09-8
Carc. 2; Skin Sens. 1
219-014-5
2314-97-8
Muta. 2
200-929-3
76-05-1
Acute Tox. 4; Skin Corr. 1A
614-708-8
68694-11-1
Repr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
604-237-6
141517-21-7
Skin Sens. 1
215-812-2
1420-06-0
Acute Tox. 4
-
-
Acute Tox. 2; Acute Tox. 1
204-469-4
121-44-8
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
201-114-5
78-40-0
Acute Tox. 4
TRIETHYLARSENAT; TRIETHYLARSENATE; TRIETHYLARSENATE (TEASAT)
427-700-2
15606-95-8
Carc. 1A; Acute Tox. 3
yes
DYNASILAN BH N; DYNASILAN BSM 100 N; DYNASILAN NH 42
402-810-3
17980-47-1
Skin Irrit. 2

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