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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 19 April 2024. Database contains 4753 unique substances/entries.
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418-270-7
-
Skin Sens. 1
205-391-3
140-01-2
Acute Tox. 4; STOT RE 2
REACTIVE NAVY BLUE 9411; SUMIFIX SUPRA MARINE BNF GRANULES
423-790-2
1379676-74-0
Eye Dam. 1; Skin Sens. 1
301-312-2
93983-23-4
Eye Irrit. 2
436-920-8
172399-10-9
Eye Dam. 1
OLIVE-GREEN JB 1170
419-210-2
178452-71-6
Eye Dam. 1
414-910-4
-
Eye Dam. 1; Skin Sens. 1
442-030-0
321912-47-4
Eye Dam. 1
256-418-0
49663-84-5
yes
215-320-8
1321-64-8
Acute Tox. 4; Eye Irrit. 2; Skin Irrit. 2
211-047-3
628-63-7
Flam. Liq. 3
211-340-6
638-49-3
Flam. Liq. 3; Eye Irrit. 2; STOT SE 3
207-332-7
463-04-7
Flam. Liq. 2; Acute Tox. 4
210-852-7
624-54-4
Flam. Liq. 3
232-629-3
9001-75-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
201-186-8
79-21-0
Flam. Liq. 3; Org. Perox. D; Acute Tox. 4; Skin Corr. 1A
603-902-8
13517-20-9
Repr. 1B; STOT SE 3; Eye Dam. 1
603-902-8
13517-20-9
yes
603-902-8
13517-20-9
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
600-611-8
10486-00-7
yes
600-611-8
10486-00-7
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
600-611-8
10486-00-7
Repr. 1B; STOT SE 3; Eye Dam. 1
600-419-4
10332-33-9
yes
600-419-4
10332-33-9
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
600-419-4
10332-33-9
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
234-390-0
11138-47-9;12040-72-1;37244-98-7
yes
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
234-390-0
11138-47-9;12040-72-1;37244-98-7
Repr. 1B; STOT SE 3; Eye Dam. 1
234-390-0
11138-47-9;12040-72-1;37244-98-7
yes
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 3; Acute Tox. 4; STOT SE 3; Eye Dam. 1
234-390-0
11138-47-9;12040-72-1;37244-98-7
Ox. Sol. 3; Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
234-390-0
11138-47-9;12040-72-1;37244-98-7
Repr. 1B; Acute Tox. 4; STOT SE 3; Eye Dam. 1
234-390-0
11138-47-9;12040-72-1;37244-98-7
yes
231-512-4
7601-90-3
Ox. Liq. 1; Skin Corr. 1A
253-718-3
37924-13-3
Acute Tox. 4; Eye Irrit. 2
206-793-1
375-73-5
yes
206-587-1
355-46-4
yes
206-801-3
375-95-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
-
21049-39-8
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
217-179-8
1763-23-1
Carc. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Lact.
206-397-9
335-67-1
Carc. 2; Repr. 1B; Lact.; Acute Tox. 4; STOT RE 1; Eye Dam. 1
yes
258-067-9
52645-53-1
Acute Tox. 4; Skin Sens. 1
600-765-6
106700-29-2
Acute Tox. 4; Skin Sens. 1
A complex combination of hydrocarbons obtained when petrolatum is treated with Al2O3 to remove polar components and impurities. It consists predominantly of saturated, crystalline, and liquid hydrocarbons having carbon numbers predominantly greater than C25.
285-098-5
85029-74-9
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of petroleum petrolatum with activated carbon for the removal of trace polar constituents and impurities. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly greater than C20.
308-149-6
97862-97-0
Carc. 1B
A complex combination of hydrocarbons obtained by treatment of petrolatum with bleaching earth for the removal of traces of polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of greater than C25.
309-706-6
100684-33-1
Carc. 1B
A complex combination of hydrocarbons obtained as a semi-solid from dewaxed paraffinic residual oil treated with hydrogen in the presence of a catalyst. It consists predominantly of saturated microcrystalline and liquid hydrocarbons having carbon numbers predominantly greater than C20.
295-459-9
92045-77-7
Carc. 1B
A complex combination of organic compounds, predominantly high molecular weight carboxylic acids, obtained by the air oxidation of petrolatum.
265-206-7
64743-01-7
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of petroleum petrolatum with silicic acid for the removal of trace polar constituents and impurities. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly greater than C20.
308-150-1
97862-98-1
Carc. 1B

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