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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 February 2024. Database contains 4753 unique substances/entries.
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ACETOCURE 97; GENOCURE*PMP; IGM 4817; IRGACURE 907; SPEEDCURE 97
400-600-6
71868-10-5
Repr. 1B; Acute Tox. 4
yes
ENS 125
402-690-2
148292-41-5
Acute Tox. 4
THANCAT AN 10
404-810-9
4524-95-2
Flam. Liq. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
419-030-4
125804-20-8
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
CG 31-1919
410-760-9
157661-93-3
Skin Irrit. 2; Skin Sens. 1
204-455-8
121-21-1
Acute Tox. 4
204-462-6
121-29-9
Acute Tox. 4
PAMPLEFLEUR
402-770-7
92585-24-5
Skin Sens. 1
AF-336
400-530-6
723-38-6
Eye Dam. 1; Skin Sens. 1
ROSAPHEN
405-890-8
25634-93-9
Eye Irrit. 2; Skin Irrit. 2
444-970-7
7340-90-1
Flam. Liq. 3; Repr. 2; STOT RE 2; Asp. Tox. 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1; STOT SE 3
202-039-0
91-08-7
Carc. 2; Acute Tox. 2; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
212-513-9
823-40-5
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2; Skin Sens. 1
212-513-9
823-40-5
Muta. 2; Acute Tox. 4; Skin Sens. 1
228-871-4
6369-59-1
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
210-431-8
615-50-9
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
202-442-1
95-70-5
Acute Tox. 3; Acute Tox. 4; Skin Sens. 1
203-710-0
109-83-1
Acute Tox. 4; Skin Corr. 1B
200-878-7
75-55-8
Flam. Liq. 2; Carc. 1B; Acute Tox. 2; Acute Tox. 1; Eye Dam. 1
200-908-9
75-85-4
Flam. Liq. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
210-843-8
624-41-9
Flam. Liq. 3
252-343-2
35073-27-9
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
219-449-0
2438-20-2
Flam. Liq. 3
209-512-0
583-59-5
Acute Tox. 4
209-513-6
583-60-8
Flam. Liq. 3; Acute Tox. 4
209-747-9
592-27-8
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
209-730-6
591-76-4
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
211-765-7
693-98-1
Repr. 1B
yes
220-239-6
2682-20-4
Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B; Eye Dam. 1; Skin Sens. 1A
203-489-0
107-41-5
Eye Irrit. 2; Skin Irrit. 2
201-148-0
78-83-1
Flam. Liq. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
200-889-7
75-65-0
Flam. Liq. 2; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
204-066-3
115-11-7
Flam. Gas 1; Press. Gas
D(+)-LACTATE D'ISOBUTYLE
407-770-0
61597-96-4
Eye Irrit. 2
VINYLMILCHSÄURE-ISO-BUTYLESTER
406-235-9
72531-53-4
Eye Irrit. 2; Skin Irrit. 2
203-643-7
109-06-8
Flam. Liq. 3; Acute Tox. 4; Eye Irrit. 2; STOT SE 3
210-256-7
611-15-4
Acute Tox. 4
SUBSTANCE S123386; VANQUISH 100
420-590-7
4299-07-4
Skin Corr. 1B; Skin Sens. 1
AF-368
406-400-5
4595-26-0
STOT RE 2; Skin Irrit. 2; Skin Sens. 1
205-182-7
135-19-3
Acute Tox. 4
202-080-4
91-59-8
Carc. 1A; Acute Tox. 4
2-NAPHTHYLAMIN-6-SULFOMETHYLAMID; FAT 92'365/A
412-120-4
104295-55-8
STOT RE 2; Skin Sens. 1
2-NPP
410-360-4
5428-02-4
STOT RE 1; Acute Tox. 4; Skin Sens. 1
202-547-2
96-96-8
Acute Tox. 2; Acute Tox. 1; STOT RE 2
202-052-1
91-23-6
Carc. 1B; Acute Tox. 4
209-474-5
581-89-5
Carc. 1B
201-209-1
79-46-9
Flam. Liq. 3; Carc. 1B; Acute Tox. 4
201-853-3
88-72-2
Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 4
204-589-7
122-99-6
Acute Tox. 4; Eye Irrit. 2
1,3-PPD
411-810-2
1570-95-2
Eye Dam. 1

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