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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 23 April 2024. Database contains 4753 unique substances/entries.
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234-828-0
12035-64-2
Carc. 1A; STOT RE 1; Skin Sens. 1
235-033-1
12059-14-2
Carc. 1A; STOT RE 1; Skin Sens. 1
215-217-8
1314-06-3
Carc. 1A; STOT RE 1; Skin Sens. 1
234-126-4
10544-72-6
Press. Gas; Ox. Gas 1; Acute Tox. 2; Skin Corr. 1B
215-813-8
1420-07-1
Repr. 1B; Acute Tox. 2; Acute Tox. 3
235-702-8
12578-12-0
yes
CYRACURE (R) PHOTOINITIATOR UVI-6974; CYRACURE PHOTOINITIATOR UVI-6976
403-500-0
159120-95-3
Skin Sens. 1
204-539-4
122-39-4
Acute Tox. 3; STOT RE 2
-
19372-20-4
Carc. 1A; STOT RE 1; Resp. Sens. 1; Skin Sens. 1
215-242-4
1314-80-3
Flam. Sol. 1; Water-react. 1; Acute Tox. 4
240-979-3
16921-30-5
Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
215-197-0
1312-73-8
Skin Corr. 1B
233-050-9
10025-99-7
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
203-869-6
111-43-3
Flam. Liq. 2; STOT SE 3
205-565-9
142-84-7
Flam. Liq. 2; Acute Tox. 4; Skin Corr. 1A
SÄUREBRAUN 8507
404-930-1
118556-91-5
Acute Tox. 4; Eye Dam. 1
427-310-2
180850-95-7
Eye Dam. 1
REACTIVE BLUE FC 60866
414-040-5
149530-93-8
Acute Tox. 4; Skin Sens. 1
217-710-3
1937-37-7
Carc. 1B; Repr. 2
yes
YELLOW DO 2286
412-530-3
157627-98-0
Eye Dam. 1; Skin Sens. 1
EVERZOL ORANGE GR; ORANGE HF-SNK; REAKTIV ORANGE FD 19969 FW
404-600-7
129009-88-7
Skin Sens. 1
SCARLET X-GA 1491
410-390-8
147703-64-8
Eye Dam. 1
240-983-5
16923-58-3
Acute Tox. 3; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
234-541-0
12008-41-2
Repr. 1B
yes
602-894-3
12280-03-4
Repr. 1B
215-211-5
1313-82-2
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1B
603-411-9
1303-96-4
Repr. 1B
yes
601-808-1
12179-04-3
Repr. 1B
yes
215-540-4
1330-43-4
Repr. 1B
yes
233-051-4
10026-00-3
Acute Tox. 3; Skin Irrit. 2; Eye Dam. 1; Resp. Sens. 1; Skin Sens. 1
240-221-1
16071-86-6
Carc. 1B
A residue from the distillation of crude benzole to remove benzole fronts. Composed primarily of benzene, toluene and xylenes boiling in the range of approximately 75°C to 200°C (167°F to 392°F).
309-984-9
101896-26-8
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained from the distillation of crude benzole (high temperature coal tar). It may be a liquid with the approximate distillation range of 150°C to 300°C (302°F to 572°F) or a semi-solid or solid with a melting point up to 70°C (158°F). It is composed primarily of naphthalene and alkyl naphthalenes.
310-165-3
121620-46-0
Carc. 1B; Muta. 1B
A distillate from the fractional distillation of high temperature coal tar. Composed primarily of alkyl-substituted one ring aromatic hydrocarbons boiling in the range of approximately 135°C to 210°C (275°F to 410°F). May also include unsaturated hydrocarbons such as indene and coumarone.
309-971-8
101794-90-5
Carc. 1B; Muta. 1B
A distillate from the fractional distillation of high temperature coal tar. Composed primarily of indole and methylnaphthalene boiling in the range of approximately 235°C to 255°C (455°F to 491°F).
309-972-3
101794-91-6
Carc. 1B; Muta. 1B
A distillate from the fractional distillation of high temperature coal tar. Composed primarily of substituted two ring aromatic hydrocarbons and aromatic nitrogen bases boiling in the range of approximately 225°C to 255°C (437°F to 491°F).
309-985-4
101896-27-9
Carc. 1B; Muta. 1B
The oil obtained from condensation of the vapors from the heat treatment of pitch. Composed primarily of two- to four-ring aromatic compounds boiling in the range of 200°C to greater than 400°C (392°F to greater than 752°F).
309-855-7
101316-49-8
Carc. 1B
A complex combination of hydrocarbons obtained by the distillation of petroleum light fraction, hydrodesulfurized and dearomatized. It consists predominantly of hydrocarbons having carbon numbers in the range of C7 through C9, predominantly C8 paraffins and cycloparaffins, boiling in the range of approximately 120°C to 130°C (248°F to 266°F).
309-862-5
101316-56-7
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by the treatment of a petroleum oil fraction with activated charcoal for the removal of traces of polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C12 through C28.
309-667-5
100683-97-4
Carc. 1B
A complex combination of hydrocarbons obtained by distillation of catalytic cracking heavy tars. It consists predominantly of highly alkylated aromatic hydrocarbons boiling in the range of approximately 100°C to 250°C (212°F to 482°F).
309-938-8
101631-13-4
Asp. Tox. 1
A complex combination of hydrocarbons obtained by distillation of steam cracking heavy residues. It consists predominantly of highly alkylated heavy aromatic hydrocarbons boiling in the range of approximately 250°C to 400°C (482°F to 752°F).
309-939-3
101631-14-5
Carc. 1B
A complex combination of hydrocarbons obtained by fractionation from hydrodesulphurised coker distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C8 through C16 and boiling in the range of approximately 120°C to 283°C (248°F to 541°F).
309-864-6
101316-58-9
Asp. Tox. 1
A complex combination of hydrocarbons obtained by treating a petroleum stock with hydrogen. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C9 through C25 and boiling in the range of approximately 150°C to 400°C (302°F to 752°F).
309-863-0
101316-57-8
Carc. 1B
A complex combination of hydrocarbons obtained by fractionation from hydrodesulphurised coker distillate stocks. It consists of hydrocarbons having carbon numbers predominantly in the range of C12 through C21 and boiling in the range of approximately 200°C to 360°C (392°F to 680°F).
309-865-1
101316-59-0
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of petroleum with activated charcoal for the removal of trace polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C16 through C36.
309-668-0
100683-98-5
Carc. 1B
A complex combination of hydrocarbons obtained by the treatment of petroleum with bleaching earth for the removal of trace polar constituents and impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C16 through C36.
309-669-6
100683-99-6
Carc. 1B
A complex combination of hydrocarbons obtained by distillation of steam cracking heavy tars. It consists predominantly of highly alkylated aromatic hydrocarbons boiling in the range of approximately 100°C to 250°C (212°F to 482°F).
309-940-9
101631-15-6
Asp. Tox. 1
A complex combination of hydrocarbons obtained by distillation of thermal-cracking heavy tars. It consists predominantly of highly alkylated aromatic hydrocarbons boiling in the range of approximately 100°C to 250°C (212°F to 482°F).
309-866-7
101316-61-4
Asp. Tox. 1
205-259-5
149-26-8
Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
233-036-2
10025-67-9
Acute Tox. 3; Acute Tox. 4; Skin Corr. 1A

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