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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 27 May 2024. Database contains 4753 unique substances/entries.
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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
236-771-7
13477-70-8
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
202-908-4
101-02-0
Eye Irrit. 2; Skin Irrit. 2
204-118-5
115-96-8
Carc. 2; Repr. 1B; Acute Tox. 4
yes
213-934-0
1067-53-4
Repr. 1B
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
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
BLEU REACTIF CAC 10; DIOXAZINE MONCHLORTRIAZINE; FAT NO. 40 407; REACTIVE BLUE CAC 10
410-130-3
136248-03-8
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
SOLAMINLICHTBLAU VGRL 133
413-590-3
164058-22-4
Carc. 1B
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
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
REACTIVE BLUE 245
407-580-8
130201-51-3
Eye Dam. 1
604-291-0
142469-14-5
Skin Sens. 1
215-244-5
1314-84-7
Water-react. 1; Acute Tox. 2
ITC 826 CONCENTRATE
422-720-8
166242-53-1
Carc. 2; Acute Tox. 4; STOT RE 2; Skin Corr. 1B; Skin Sens. 1
203-677-2
109-52-4
Skin Corr. 1B
217-681-7
1929-77-7
Acute Tox. 4
203-545-4
108-05-4
Flam. Liq. 2; Carc. 2; Acute Tox. 4; STOT SE 3
601-810-2
12185-10-3
Pyr. Sol. 1; Acute Tox. 2; Skin Corr. 1A
215-535-7
1330-20-7
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
215-089-3
1300-71-6
Acute Tox. 3; Skin Corr. 1B
215-091-4
1300-73-8
Acute Tox. 3; STOT RE 2
Z-6
402-280-3
149144-82-1
Eye Irrit. 2; Skin Irrit. 2
205-232-8
136-23-2
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
238-270-9
14324-55-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
417-130-2
1379689-21-0
Eye Dam. 1
235-180-1
12122-67-7
STOT SE 3; Skin Sens. 1
205-288-3
137-30-4
Acute Tox. 2; Acute Tox. 4; STOT RE 2; STOT SE 3; Eye Dam. 1; Skin Sens. 1
605-037-1
156052-68-5
Skin Sens. 1
ACRYLOXYPROPYL DIMETHOXYSILOXY TERMINATED POLYDIMETHYL SILOXANE
415-290-8
193159-06-7
Skin Sens. 1
202-847-3
100-39-0
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
202-853-6
100-44-7
Carc. 1B; Acute Tox. 3; Acute Tox. 4; STOT RE 2; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
639-478-6
182635-99-0
Acute Tox. 4; Skin Corr. 1B
PC-709
413-420-8
144736-29-8
Skin Corr. 1B; Skin Sens. 1
203-313-2
105-60-2
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
427-580-1
211299-54-6
Skin Irrit. 2
220-384-5
2746-19-2
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
CP-141,845-27
426-740-8
256369-40-1
Acute Tox. 4; Eye Dam. 1

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