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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 16 April 2024. Database contains 4753 unique substances/entries.
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203-737-8
110-12-3
Flam. Liq. 3; Acute Tox. 4
5-METHYLPYRAZINE-2-CARBOXYLIC ACID; ACIDO 5-METILPIRAZIN CARBOSSILICO
413-260-9
5521-55-1
Eye Dam. 1
202-765-8
99-55-8
Carc. 2; Acute Tox. 3
256-960-8
51085-52-0
Carc. 2; Acute Tox. 3
210-025-0
602-87-9
Carc. 1B
-
-
yes
-
-
yes
-
-
yes
BISOX HCL
404-840-2
164578-13-6
Acute Tox. 4; STOT RE 2; Eye Dam. 1
A-87440.0; A-87440.00
414-780-9
38585-74-9
Eye Dam. 1
ROUGE TZ 4075
418-340-7
157707-94-3
Eye Dam. 1
BLEU REN 20
418-000-8
163062-28-0
Eye Dam. 1
441-550-5
-
Self-react. C; Carc. 2
301-467-6
94021-76-8
Acute Tox. 2; STOT RE 1; Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
239-732-2
15662-33-6
Acute Tox. 4
RONACAT RO 305; RONACOAT RO 305
404-870-6
63740-41-0
Skin Sens. 1
ELFADOX EN 3001
406-680-9
104788-63-8
Org. Perox. C; Eye Dam. 1; Skin Sens. 1
PAP
410-850-8
128275-31-0
Org. Perox. D; Eye Dam. 1
AF-507; M-3181
404-680-3
1862-07-3
Acute Tox. 4; Skin Corr. 1B
ENS 131
404-550-6
130263-41-1
Skin Sens. 1
UK-103,442
422-460-5
137234-87-8
Acute Tox. 4
IN-4; INDENE IN-4
405-410-7
41201-60-9
Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
429-960-2
27610-48-6
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
ARANCIO DISPERSO 149; C.I. DISPERSE ORANGE 149; DISPERS ORANGE 149; DISPERSE ORANGE 149; ORANGE DISPERSE 149; TERASIL GOLDGELB 2RS
400-340-3
85136-74-9
Carc. 1B
IMEXINE OBA
417-020-4
2380-86-1
Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
204-419-1
120-71-8
Carc. 1B; Acute Tox. 4
yes
DM-C-TDA; DMTDA; ETHACURE (R) 300 CURATIVE
403-240-8
106264-79-3
Acute Tox. 4; Skin Sens. 1
202-095-6
91-76-9
Acute Tox. 4
FLEXSORB-SE
400-390-6
87787-67-5
Skin Corr. 1A; Acute Tox. 4
ORANGE BIREACTIVE DYE
407-050-6
117715-57-8
Skin Sens. 1
TACS
403-690-5
111298-82-9
Resp. Sens. 1; Skin Sens. 1
424-850-0
189702-72-5
Eye Dam. 1
FLUORCHINOLONCARBONSÄURE
405-050-0
86393-33-1
Acute Tox. 4
429-400-7
199327-61-2
Repr. 1B
7-METHYL-1,6-OCTADIENE
404-210-7
42152-47-6
Flam. Liq. 3
ZOLDINE RD-20
417-140-7
79185-77-6
Skin Irrit. 2
OPALAL
424-030-2
62406-73-9
Skin Irrit. 2
-
10027-06-2
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
204-957-7
129-64-6
Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
620-411-4
123748-85-6
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
8-AMINO-7-METHYLCHINOLIN
412-760-4
5470-82-6
Acute Tox. 4; Skin Sens. 1
3,3-TETRAMETHYLENE GLUTARIMIDE
427-770-4
1075-89-4
Acute Tox. 3
201-281-4
80-47-7
Org. Perox. D; Skin Corr. 1B; Acute Tox. 4
BPFL; FLUOREN-BIS-PHENOL
406-950-6
3236-71-3
Eye Irrit. 2; Skin Irrit. 2
FLEUROXENE
430-830-2
26912-64-1
Skin Irrit. 2
216-055-0
1484-13-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
421-940-1
28698-31-9
Eye Dam. 1
416-360-0
162221-28-5
Skin Sens. 1
M1
422-060-0
137390-08-0
Acute Tox. 2
218-575-3
2186-25-6
Muta. 2; Skin Irrit. 2; Skin Sens. 1

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