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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 21 June 2024. Database contains 4753 unique substances/entries.
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202-848-9
100-40-3
Carc. 2
204-255-0
118-48-9
Eye Irrit. 2; Skin Sens. 1
204-525-8
122-15-6
Acute Tox. 3
PIGMENTROT 1017; SUBSTANCE H112287
405-100-1
115662-06-1
Repr. 2
421-170-6
138937-28-7
Acute Tox. 4; Eye Dam. 1
410-530-8
107815-88-3
Skin Sens. 1
WAY-128170
420-820-6
153042-18-3
Flam. Liq. 3; Acute Tox. 4
414-410-6
1379676-83-1
Eye Dam. 1; Skin Sens. 1
ROUGE REACTIF REN 208
418-380-5
168113-78-8
Eye Dam. 1
433-530-1
143446-73-5
Acute Tox. 4; Skin Sens. 1
5-ACETYL-3-AMINO-IMINODIBENZYL.HCL
410-490-1
138451-65-7
Acute Tox. 4; STOT RE 2; Eye Dam. 1; Skin Sens. 1
CP-13,853
412-200-9
17630-75-0
Repr. 2; Acute Tox. 4; Skin Sens. 1
203-737-8
110-12-3
Flam. Liq. 3; Acute Tox. 4
BISOX HCL
404-840-2
164578-13-6
Acute Tox. 4; STOT RE 2; 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
239-732-2
15662-33-6
Acute Tox. 4
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
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
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
429-400-7
199327-61-2
Repr. 1B
-
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
3,3-TETRAMETHYLENE GLUTARIMIDE
427-770-4
1075-89-4
Acute Tox. 3
216-055-0
1484-13-5
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
416-360-0
162221-28-5
Skin Sens. 1
M1
422-060-0
137390-08-0
Acute Tox. 2
433-690-0
167678-46-8
Skin Corr. 1A; Skin Sens. 1
419-270-1
123599-82-6
Eye Irrit. 2
235-715-9
12607-70-4
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
419-840-8
169104-71-6
Flam. Sol. 1; Skin Corr. 1B; Skin Sens. 1
425-520-9
197179-61-6
Eye Dam. 1
SQ 28,796
415-820-8
137590-32-0
Eye Dam. 1; Skin Sens. 1
CCA-VERSUCHSPRODUKT SN 4001
405-080-4
118725-24-9
Eye Dam. 1
A complex combination of hydrocarbons obtained as a redistillate from the distillation of wash oil. It consists predominantly of 2-ringed aromatic and heterocyclic hydrocarbons boiling in the range of approximately 260°C to 290°C (500°F to 554°F).
309-851-5
101316-45-4
Carc. 1B
603-921-1
135410-20-7
Acute Tox. 4
203-564-8
108-24-7
Flam. Liq. 3; Acute Tox. 4; Skin Corr. 1B
CGA 245704 TECH.
420-050-0
135158-54-2
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
203-453-4
107-02-8
Flam. Liq. 2; Acute Tox. 1; Acute Tox. 2; Acute Tox. 3; Skin Corr. 1B
203-466-5
107-13-1
Flam. Liq. 2; Carc. 1B; Acute Tox. 3; STOT SE 3; Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
204-673-3
124-04-9
Eye Irrit. 2
240-110-8
15972-60-8
Carc. 2; Acute Tox. 4; Skin Sens. 1

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