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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 17 May 2024. Database contains 4753 unique substances/entries.
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236-771-7
13477-70-8
Carc. 1A; STOT RE 1; Skin Sens. 1
-
74646-29-0
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
234-495-1
12007-02-2
Carc. 1A; STOT RE 1; Skin Sens. 1
234-829-6
12035-72-2
Carc. 1A; Muta. 2; STOT RE 1; Skin Sens. 1
-
12137-12-1
Carc. 1A; STOT RE 1; Skin Sens. 1
TZ 02508
413-320-4
869-59-0
STOT RE 1; Skin Irrit. 2
-
-
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-908-4
101-02-0
Eye Irrit. 2; Skin Irrit. 2
442-960-7
332350-93-3
Acute Tox. 3; Eye Dam. 1
-
-
Acute Tox. 3
TRYPROPYLAMMONIUM DIHYDROGENPHOSPHAT
433-700-3
35687-90-2
Acute Tox. 4
-
-
Acute Tox. 3
-
7276-58-6
Acute Tox. 4
ACETOACETYLORTHOSINIC ACID, A6-SALT
403-760-5
68030-79-5
Skin Sens. 1
204-118-5
115-96-8
Carc. 2; Repr. 1B; Acute Tox. 4
yes
213-934-0
1067-53-4
Repr. 1B
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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-sec-nonyl-, phosphite EC / List no: - | CAS no: 106599-06-8
Phenol, p-isononyl-, phosphite (3:1) EC / List no: - | CAS no: 31631-13-7
Tris(nonylphenyl) phosphite EC / List no: 247-759-6 | CAS no: 26523-78-4
799-976-5
-
yes
247-759-6
26523-78-4
Skin Sens. 1
yes
PIGMENTBLAU 1755
403-210-4
108300-90-9
Eye Dam. 1
LEXMARK YELLOW DYE 415; PRISM YELLOW
406-073-9
131013-81-5
Acute Tox. 3
237-159-2
13674-87-8
Carc. 2
BROWN 1612969
407-110-1
480445-87-2
Eye Dam. 1; Skin Sens. 1
SÄUREBLAU 82 226
402-500-8
104105-46-6
Eye Dam. 1
SCARLET 12 04 262
406-820-9
159317-41-6
Eye Irrit. 2
BLUE TZ 4312
423-770-3
-
Eye Dam. 1
427-710-7
215612-56-9
Eye Dam. 1; Skin Sens. 1
429-240-8
212652-59-0
Eye Dam. 1
BLEU REACTIF CAC 10; DIOXAZINE MONCHLORTRIAZINE; FAT NO. 40 407; REACTIVE BLUE CAC 10
410-130-3
136248-03-8
Skin Sens. 1
430-280-3
844491-96-9
Skin Sens. 1
440-480-2
341026-59-3
Eye Dam. 1; Skin Sens. 1
C.I. REACTIVE YELLOW 174; GIALLO REATTIVO 174; JAUNE REACTIF 174; REAKTIV GELB 174
402-170-5
106359-91-5
Skin Sens. 1
423-100-1
-
Eye Dam. 1
TURQUOISE 10 40 518
411-430-7
-
Eye Dam. 1; Skin Sens. 1
SOLAMINLICHTBLAU VGRL 133
413-590-3
164058-22-4
Carc. 1B
ACID BLUE 349; AZO-METALCOMPLEX-BLUE AP 1149; BLEU ACIDE 349; C.I. ACID BLUE 349; SELLASET BLEU H; SELLASET BLUE H
402-870-0
93952-24-0
Eye Dam. 1
BI 3277; NOIR CORSE SANODAL H3LW CONC.; SANODAL DEEP BLACK H-3LW CONC.; SANODAL TIEFSCHWARZ H-3LW; SANODAL TIEFSCHWARZ H-3LW KONZ.
400-810-8
106084-79-1
Muta. 2
RED JB 747
418-220-4
-
Skin Sens. 1
237-410-6
13775-53-6
STOT RE 1; Acute Tox. 4
239-148-8
15096-52-3
STOT RE 1; Acute Tox. 4
TRILON(R) ES 9910
414-130-4
119710-96-2
Acute Tox. 4
TRILON(R) ES 9851
414-070-9
129050-62-0
Skin Corr. 1B
422-090-4
172737-80-3
Eye Dam. 1
225-768-6
5064-31-3
Carc. 2; Acute Tox. 4; Eye Irrit. 2
REACTIVE BLUE 245
407-580-8
130201-51-3
Eye Dam. 1
604-291-0
142469-14-5
Skin Sens. 1
246-677-8
25155-23-1
Repr. 1B
yes
215-244-5
1314-84-7
Water-react. 1; Acute Tox. 2
218-828-8
2244-21-5
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
220-767-7
2893-78-9
Ox. Sol. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3

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