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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 27 May 2024. Database contains 4753 unique substances/entries.
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The distillate from coke oven light oil having an approximate distillation range below 100°C (212°F). Composed primarily of C4 to C6 aliphatic hydrocarbons.
266-023-5
65996-88-5
Carc. 1B; Muta. 1B
TINUVIN 780
402-940-0
62782-03-0
Eye Irrit. 2
DI(2-ETHYLHEXYL)DITHIODIGLYKOLAT; DP 327
404-510-8
62268-47-7
Acute Tox. 4; Skin Sens. 1
GR101655A
423-170-1
618-26-8
Flam. Liq. 2; STOT RE 1; Acute Tox. 4; Eye Dam. 1; Skin Sens. 1
INTERSEPT
404-690-8
68132-19-4
Acute Tox. 3; Skin Corr. 1B; Skin Sens. 1
229-879-0
6804-07-5
Flam. Sol. 1; Carc. 1B; Acute Tox. 4
200-555-0
63-25-2
Carc. 2; Acute Tox. 4
211-128-3
630-08-0
Flam. Gas 1; Press. Gas; Repr. 1A; Acute Tox. 3; STOT RE 1
228-200-5
6164-98-3
Carc. 2; Acute Tox. 4
200-663-8
67-66-3
Carc. 2; Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Eye Irrit. 2; Skin Irrit. 2
264-409-8
63681-54-9
Muta. 2; Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
PD 133602-2
417-430-3
63645-17-0
Acute Tox. 3; STOT RE 2; Skin Sens. 1
A complex combination of hydrocarbons produced as the residual fraction from distillation of the products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-064-6
64741-62-4
Carc. 1B
A complex combination of hydrocarbons obtained by treating catalytic cracked clarified oil with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
269-782-0
68333-26-6
Carc. 1B
268-169-5
68016-03-5
Carc. 1A; STOT RE 1; Skin Sens. 1
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77332.
269-051-6
68186-89-0
Carc. 1A; STOT RE 1; Skin Sens. 1
200-598-5
64-86-8
Muta. 1B; Acute Tox. 2
200-673-2
67-97-0
Acute Tox. 2; STOT RE 1
ALLYL SUCROSE
419-640-0
68784-14-5
Acute Tox. 4
-
68583-16-4
B Bacteria and similar species
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic hydrocarbons and may contain appreciable quantities of tar acids and tar bases. It distills at the approximate range of 200°C to 325°C (392°F to 617°F).
263-047-8
61789-28-4
Carc. 1B
200-636-0
66-81-9
Muta. 2; Repr. 1B; Acute Tox. 2
227-964-7
6053-68-5
Eye Irrit. 2; STOT SE 3
269-855-7
68359-37-5
Acute Tox. 2; Acute Tox. 3
269-855-7
68359-37-5
Acute Tox. 2
274-050-9
69581-33-5
Acute Tox. 3; Acute Tox. 4
DEM
408-120-9
65197-96-8
Acute Tox. 4; Eye Dam. 1
211-666-9
682-80-4
Acute Tox. 2; Acute Tox. 3
210-937-9
626-23-3
Flam. Liq. 3; Acute Tox. 4
211-670-0
683-18-1
Muta. 2; Repr. 1B; Acute Tox. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 1; Skin Corr. 1B
yes
200-547-7
62-73-7
Acute Tox. 2; Acute Tox. 3; Skin Sens. 1
200-632-9
66-76-2
STOT RE 1; Acute Tox. 4
200-484-5
60-57-1
Carc. 2; Acute Tox. 1; Acute Tox. 3; STOT RE 1
200-467-2
60-29-7
Flam. Liq. 1; Acute Tox. 4; STOT SE 3
200-589-6
64-67-5
Carc. 1B; Muta. 1B; Acute Tox. 4; Skin Corr. 1B
yes
211-000-7
627-44-1
Acute Tox. 2; Acute Tox. 1; STOT RE 2
270-877-4
68479-98-1
Acute Tox. 4; STOT RE 2; Eye Irrit. 2
210-088-4
605-50-5
Repr. 1B
yes
211-617-1
674-82-8
Flam. Liq. 3; Acute Tox. 4
262-784-2
61432-55-1
Acute Tox. 4
200-480-3
60-51-5
Acute Tox. 4
432-310-0
617-55-0
Flam. Liq. 3; Eye Dam. 1; Skin Sens. 1
210-478-4
616-38-6
Flam. Liq. 2
210-871-0
624-92-0
Flam. Liq. 2; Acute Tox. 3; STOT SE 3; STOT SE 1; Eye Irrit. 2; Skin Sens. 1
200-549-8
62-75-9
Carc. 1B; Acute Tox. 2; Acute Tox. 3; STOT RE 1
-
63919-26-6
Acute Tox. 4
230-253-4
6988-21-2
Acute Tox. 3
229-912-9
6834-92-0
Skin Corr. 1B; STOT SE 3
The distillate from coal tar having an approximate distillation range of 220°C to 450°C (428°F to 842°F). Composed primarily of three to four membered condensed ring aromatic hydrocarbons and other hydrocarbons.
266-026-1
65996-91-0
Carc. 1B
The distillate from coal tar having an approximate distillation range of 100°C to 450°C (212°F to 842°F). Composed primarily of two to four membered condensed ring aromatic hydrocarbons, phenolic compounds, and aromatic nitrogen bases.
266-027-7
65996-92-1
Carc. 1B

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