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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 23 February 2024. Database contains 4753 unique substances/entries.
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HR-11
419-770-8
136122-15-1
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
209-745-8
592-13-2
Flam. Liq. 2; Asp. Tox. 1; Skin Irrit. 2; STOT SE 3
206-348-1
329-71-5
Acute Tox. 3; STOT RE 2
210-581-4
619-15-8
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
424-660-8
-
STOT RE 2; Eye Dam. 1; Skin Sens. 1
202-461-5
95-87-4
Acute Tox. 3; Skin Corr. 1B
440-030-5
338735-71-0
Skin Irrit. 2; Eye Dam. 1
429-460-4
7078-98-0
Skin Sens. 1
444-250-2
144111-81-9
Self-react. C
VIOLETT MIP 3250
424-120-1
174514-06-8
Eye Dam. 1
218-255-3
2095-01-4
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
AZOGELB
421-430-9
28365-08-4
Acute Tox. 4; STOT RE 2
FPB 800
427-400-1
140623-89-8
Skin Corr. 1B; Acute Tox. 4; Skin Sens. 1
T 1049
403-350-6
17742-69-7
Acute Tox. 3
DICHLORO-2,6 P.T.F.M.A.
416-430-0
24279-39-8
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
209-445-7
579-66-8
Acute Tox. 4
203-620-1
108-83-8
Flam. Liq. 3; STOT SE 3
209-357-9
573-56-8
Acute Tox. 3; STOT RE 2
210-106-0
606-20-2
Carc. 1B; Muta. 2; Repr. 2; Acute Tox. 3; STOT RE 2
209-400-1
576-26-1
Acute Tox. 3; Skin Corr. 1B
201-758-7
87-62-7
Carc. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2
C25-ALDEHYD
415-770-7
1638-05-7
STOT RE 2; Skin Sens. 1
-
72319-19-8
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
PIGMENT ADDITIV AC; PIGMENTADDITIV AC
404-230-6
164578-11-4
Skin Sens. 1
FAT 40'398; FAT 40'398/E
411-100-2
136213-73-5
STOT RE 2; Skin Sens. 1
RO 1082
411-260-3
117907-43-4
Eye Dam. 1; Skin Sens. 1
METHYLGELB
408-090-7
100418-33-5
Acute Tox. 4; Skin Sens. 1
2S4TBP
421-740-4
51390-14-8
Skin Corr. 1B
426-480-5
63562-33-4
Skin Sens. 1
TAA
407-850-5
89544-40-1
Acute Tox. 4; Eye Dam. 1
EPO
411-210-0
89544-48-9
Skin Irrit. 2; Skin Sens. 1
THANCAT AN 20
407-360-1
116230-20-7
Acute Tox. 4; STOT RE 2; Skin Irrit. 2; Eye Dam. 1
31 AC-HCL
410-620-7
119154-86-8
Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
203-867-5
111-41-1
Repr. 1B; Skin Corr. 1B; Skin Sens. 1
GUAIACOL-O-ETHYLBROMIDE
402-010-4
4463-59-6
Acute Tox. 4
203-961-6
112-34-5
Eye Irrit. 2
203-985-7
112-56-1
Flam. Liq. 3; Acute Tox. 3
203-988-3
112-59-4
Acute Tox. 4; Eye Dam. 1
PIKRAMINROT
412-520-9
99610-72-7
Flam. Sol. 2; Repr. 2; Acute Tox. 4
BRL 47539
411-780-0
127047-77-2
Acute Tox. 4
203-906-6
111-77-3
Repr. 2
247-384-8
25973-55-1
yes
253-037-1
36437-37-3
yes
243-761-6
20354-26-1
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
425-050-4
10217-34-2
Skin Sens. 1
M-TMI
402-440-2
2094-99-7
Acute Tox. 2; Skin Corr. 1B; STOT RE 2; Resp. Sens. 1; Skin Sens. 1
CP-328,914
429-030-6
57999-49-2
Skin Sens. 1
5-CHLOR-2-PENTANON-NEOPENTYLKETAL; 5-CHLORO-2-PENTANONE-NEOPENTYLKETAL; CHLORKETAL
417-650-1
88128-57-8
STOT RE 2
SIS 46 305
408-010-0
88558-41-2
Acute Tox. 4; Eye Dam. 1
HOSTALUX VP 3481-1 HOSTALUX N2R
402-120-2
133514-97-3
Skin Corr. 1B; STOT RE 2; Skin Sens. 1

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