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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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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AZURANT PYRAZOLINE MR 5401; PYRAZOLINE BRIGHTENER MR 5401; UVITEX 4457
402-490-5
106359-93-7
Eye Irrit. 2
429-180-2
157362-53-3
Skin Sens. 1
TTP MAGENTA 3
405-480-9
110260-50-9
Acute Tox. 4; STOT RE 2; Skin Irrit. 2
BRILLANT RED 1047729; BRILLIANT RED 1047729; ROUGE BRILLANT 1047729
405-440-0
149172-69-0
Skin Sens. 1
PIGMENT ADDITIV C
404-910-2
164578-14-7
Skin Sens. 1
FC-102B; M-3218
415-910-7
152828-25-6
Skin Sens. 1
202-264-4
7085-19-0;93-65-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
202-264-4
7085-19-0;93-65-2
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
420-200-5
1379676-70-6
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
428-320-1
71308-16-2
Acute Tox. 4; Skin Sens. 1
201-289-8
80-54-6
Repr. 1B
TBPE
410-020-5
5406-86-0
Repr. 2; STOT RE 2; Eye Dam. 1
443-980-9
221215-20-9
Skin Sens. 1
7-ETHYLTRYPTOPHOL
431-020-1
41340-36-7
Acute Tox. 4; STOT RE 2
XU 40304.03L ANTIMICROBIAL
405-640-8
36362-09-1
STOT RE 2; Skin Irrit. 2; Eye Dam. 1
KEINE
403-070-4
51395-42-7
Skin Corr. 1B; Skin Sens. 1
431-930-9
43028-69-9
Acute Tox. 4; Skin Sens. 1
MCPSI
410-900-9
83056-32-0
Flam. Liq. 3; Muta. 2; Acute Tox. 4; STOT RE 2; Eye Dam. 1; Resp. Sens. 1
203-052-4
102-77-2
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
EM
405-350-1
54527-73-0
Skin Sens. 1
AMINOETHER
412-310-7
37866-45-8
Skin Sens. 1
222-598-4
3547-33-9
Eye Dam. 1
420-830-0
102333-75-5
Eye Dam. 1; Skin Sens. 1
220-548-6
2807-30-9
Acute Tox. 4; Eye Irrit. 2
CSPC
411-010-3
117205-23-9
Skin Sens. 1
JEFFCAT ZF-10; TEXACAT ZF-10
406-080-7
83016-70-0
Acute Tox. 4; Skin Corr. 1B
CHLORGELB; HC YELLOW 12
413-280-8
59320-13-7
Acute Tox. 4
205-592-6
143-22-6
Eye Dam. 1
243-816-4
20427-84-3
yes
230-770-5
7311-27-5
yes
P-964
420-580-2
151798-26-4
Repr. 1B
425-760-4
64137-52-6
Eye Dam. 1
618-344-0
9002-93-1
yes
687-832-3
1119449-37-4
yes
KAYACEL YELLOW CG; NO.466 BZN
407-680-1
98809-11-1
Eye Dam. 1; Skin Sens. 1
425-160-2
24085-06-1
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
ATRAC 869
417-960-5
-
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
204-709-8
124-68-5
Eye Irrit. 2; Skin Irrit. 2
202-544-6
96-91-3
Expl. 1.1; Acute Tox. 4
202-544-6
96-91-3
Acute Tox. 4
429-560-8
4274-38-8
Skin Corr. 1B; Acute Tox. 4; STOT RE 2; Skin Sens. 1
ACIDE CÉBRANILIQUE
424-700-4
150812-32-1
Eye Dam. 1
DPX N6186; N 6186
410-050-9
5734-64-5
Acute Tox. 4
415-500-8
145963-84-4
Acute Tox. 4; STOT RE 2
2-AMINO-5-METHYLTHIAZOL
423-800-5
7305-71-7
Acute Tox. 4; STOT RE 2
DPX-D-7556
403-580-7
62096-63-3
Acute Tox. 4
205-483-3
141-43-5
Acute Tox. 4; Skin Corr. 1B
203-541-2
108-00-9
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
202-431-1
95-55-6
Muta. 2; Acute Tox. 4
200-860-9
75-31-0
Flam. Liq. 1; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2

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