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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 28 May 2024. Database contains 4753 unique substances/entries.
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SULPHONAMIDO-ANILINE
406-010-5
88918-84-7
Eye Dam. 1; Skin Sens. 1
PHOTOAMORCEUR 22074; RHODORSIL PHOTOINITIATOR 2074; TEPBI
422-960-3
178233-72-2
Acute Tox. 4; STOT RE 2
17-KETOBROMOHYDRINE
419-790-7
4229-69-0
Skin Sens. 1
PTH-AA
430-230-0
136522-17-3
Acute Tox. 4
444-350-6
133413-70-4
Eye Irrit. 2
420-380-5
136465-81-1
Acute Tox. 4; Eye Dam. 1
T 1569; T001569
423-290-4
66938-41-8
Muta. 2
222-048-3
3327-22-8
Carc. 2
428-230-0
79568-06-2
STOT RE 2
CIN 10094329; SENSIBILISATOR KF 693 PINA; SENSITIZER KF 693 PINA
422-240-9
166596-68-5
Eye Dam. 1; Skin Sens. 1
427-200-4
76646-91-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
443-560-5
88784-33-2
Eye Irrit. 2
822-682-6
1417782-03-6
Skin Sens. 1
201-501-9
83-79-4
Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
425-260-6
244634-31-9
STOT RE 2; Eye Dam. 1; Skin Sens. 1
4-AA; AOSA; AZETIDONE-KANEKA; GR91990X
408-050-9
76855-69-1
Eye Irrit. 2; Skin Sens. 1
433-820-6
118058-74-5
Eye Irrit. 2
UK-103,449-BV
427-100-0
-
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
420-370-0
6485-67-2
Eye Irrit. 2; Skin Sens. 1
440-620-2
920-36-5
Water-react. 1; Pyr. Liq. 1; Skin Corr. 1A; STOT SE 3
287-470-2
85508-45-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
284-351-7
84852-39-1
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
CLETOPROPAMINHYDROCHLORID
429-740-6
40722-80-3
Carc. 1B; Muta. 1B; STOT RE 2; Skin Sens. 1
BUTAMINONITRODARONE; SR33581
444-800-1
141645-23-0
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
X-17-17
417-410-4
61807-67-8
Acute Tox. 4; Skin Corr. 1A; Skin Sens. 1
DWS
404-940-6
86608-70-0
Acute Tox. 4; Eye Dam. 1; STOT RE 2
430-910-7
13335-71-2
Acute Tox. 4; Eye Dam. 1
433-520-5
82911-69-1
Acute Tox. 4; Skin Sens. 1
430-620-0
76145-91-0
STOT RE 2; Skin Sens. 1
439-360-2
142877-45-0
Skin Irrit. 2; Eye Dam. 1
443-840-7
4084-38-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
BLUE 10 25 964
407-240-9
159604-94-1
Skin Sens. 1
CP-141,845-27
426-740-8
256369-40-1
Acute Tox. 4; Eye Dam. 1
220-384-5
2746-19-2
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
SERTRALINE STEP 2
420-560-3
79617-97-3
Eye Dam. 1
426-200-1
172015-79-1
STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
G-EXOMETHYLENE SULFOXIDE ESTER
412-800-0
76109-32-5
Resp. Sens. 1
P-NITROBENZYLESTER PGSO
412-670-5
54275-93-3
Resp. Sens. 1
-
135821-74-8
yes
-
135821-03-3
yes
CP-84,203-4; DFX-5S
411-000-9
125224-62-6
Skin Sens. 1
1418U90
418-530-1
79200-56-9
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
427-580-1
211299-54-6
Skin Irrit. 2
444-480-3
393517-29-8
Skin Irrit. 2
256-032-2
42978-66-5
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
KELCOR; LIPOKEL; SEQUOL
425-230-2
16610-63-2
Skin Corr. 1B
214-619-0
1166-46-7
Carc. 2; Acute Tox. 4; STOT SE 2
BRL 29226
406-030-4
105812-81-5
Acute Tox. 4; Eye Dam. 1
432-360-3
105813-13-6
Acute Tox. 4; Skin Sens. 1
419-620-1
-
Skin Sens. 1

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