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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 18 April 2024. Database contains 4753 unique substances/entries.
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500-036-1
25214-70-4
yes
200-001-8
50-00-0
Carc. 1B; Muta. 2; Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
614-346-0
68157-60-8
Carc. 2
A complex combination of hydrocarbons obtained as the oil fraction from a solvent deoiling or a wax sweating process. It consists predominantly of branched chain hydrocarbons having carbon numbers predominantly in the range of C20 through C50.
265-171-8
64742-67-2
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of Foots oil with silicic acid for removal of trace constituents and impurities. It consists predominantly of straight chain hydrocarbons having carbon numbers predominantly greater than C12.
308-127-6
97862-77-6
Carc. 1B
295-394-6
92045-12-0
Carc. 1B
A complex combination of hydrocarbons obtained by treatment of Foot's oil with natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. It consists predominantly of branched chain hydrocarbons with carbon numbers predominantly in the range of C20 through C50.
300-226-2
93924-32-4
Flam. Gas 1; Press. Gas; Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of Foots oil with activated carbon for the removal of trace constituents and impurities. It consists predominantly of saturated straight chain hydrocarbons having carbon numbers predominantly greater than C12.
308-126-0
97862-76-5
Carc. 1B
A complex combination of hydrocarbons obtained by treatment of Foot's oil with sulfuric acid. It consists predominantly of branched-chain hydrocarbons with carbon numbers predominantly in the range of C20 through C50.
300-225-7
93924-31-3
Flam. Gas 1; Press. Gas; Carc. 1B
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-
F Fungi
-
-
F Fungi
213-408-0
944-22-9
Acute Tox. 1; Acute Tox. 2
276-439-9
72178-02-0
Acute Tox. 4
205-088-6
133-07-3
Carc. 2; Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
617-717-5
85509-19-9
Carc. 2; Repr. 1B; Acute Tox. 4
262-661-3
61213-25-0
Repr. 1B; Acute Tox. 4; Skin Sens. 1
FLUQUINCONAZOLE
411-960-9
136426-54-5
Acute Tox. 3; STOT RE 1; Acute Tox. 4; Skin Irrit. 2
243-546-7
20153-49-5
Acute Tox. 4
243-547-2
20153-50-8
Acute Tox. 4
232-149-4
7789-21-1
Acute Tox. 4; Skin Corr. 1A
241-034-8
16961-83-4
Skin Corr. 1B
-
-
Acute Tox. 4
240-898-3
16872-11-0
Skin Corr. 1B
205-631-7
144-49-0
Acute Tox. 2
-
-
Acute Tox. 2
231-954-8
7782-41-4
Press. Gas; Ox. Gas 1; Acute Tox. 2; Skin Corr. 1A
-
-
B Bacteria and similar species
205-912-4
206-44-0
yes
600-425-7
103361-09-7
Repr. 1B
613-108-3
62924-70-3
Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1
FLUFENOXURON
417-680-3
101463-69-8
Lact.
604-290-5
142459-58-3
Acute Tox. 4; STOT RE 2; Skin Sens. 1
-
4301-50-2
Acute Tox. 1; Acute Tox. 2
253-703-1
37893-02-0
Eye Irrit. 2
616-712-5
79622-59-6
Repr. 2; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1A
616-669-2
79241-46-6
Repr. 2
274-125-6
69806-50-4
Repr. 1B
605-127-0
158062-67-0
Acute Tox. 4
FLOCOUMAFEN
421-960-0
90035-08-8
Repr. 1B; Acute Tox. 1; STOT RE 1
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-
V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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B Bacteria and similar species
424-610-5
120068-37-3
Acute Tox. 3; STOT RE 1
232-599-1
9001-33-6
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Resp. Sens. 1
238-484-2
14484-64-1
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
200-990-6
76-87-9
Carc. 2; Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
212-984-0
900-95-8
Carc. 2; Repr. 2; Acute Tox. 2; Acute Tox. 3; STOT RE 1; STOT SE 3; Skin Irrit. 2; Eye Dam. 1
200-231-9
55-38-9
Muta. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1
204-114-3
115-90-2
Acute Tox. 1; Acute Tox. 2
201-274-6
80-38-6
Acute Tox. 4; Eye Irrit. 2
603-792-1
134098-61-6
Acute Tox. 3; Acute Tox. 2; Skin Sens. 1B

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