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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 25 June 2024. Database contains 4753 unique substances/entries.
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201-143-3
78-79-5
Flam. Liq. 1; Carc. 1B; Muta. 2
220-114-6
2631-40-5
Acute Tox. 4
203-561-1
108-21-4
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
203-301-7
105-48-6
Flam. Liq. 3; Acute Tox. 3; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2
210-901-2
625-55-8
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
211-300-8
637-78-5
Flam. Liq. 2
251-835-4
34123-59-6
Carc. 2; STOT RE 2
242-624-8
18854-01-8
Acute Tox. 3
A complex combination of hydrocarbons obtained by fractionation from hydrodesulfurized thermal cracker distillate. It consists predominantly of hydrocarbons predominantly in the range of C8 to C16 and boiling in the range of approximately 120°C to 283°C (284°F to 541°F).
285-507-7
85116-55-8
Asp. Tox. 1
A complex combination of hydrocarbons obtained from a petroleum stock by treating with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists of hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 150°C to 290°C (302°F to 554°F).
265-184-9
64742-81-0
Asp. Tox. 1
A complex combination of hydrocarbons obtained from a petroleum stock by solvent refining and sweetening and boiling in the range of approximately 150°C to 260°C (302°F to 500°F).
295-416-4
92045-36-8
Asp. Tox. 1
A complex combination of hydrocarbons obtained as a wide cut hydrocarbon fuel cut from atmospheric distillation and boiling in the range of approximately 70°C to 220°C (158°F to 428°F).
295-418-5
92045-37-9
Asp. Tox. 1
A complex combination of hydrocarbons obtained by subjecting a petroleum distillate to a sweetening process to convert mercaptans or to remove acidic impurities. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of 130°C to 290°C (266°F to 554°F).
294-799-5
91770-15-9
Asp. Tox. 1
A complex combination of hydrocarbons produced by the distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C9 through C16 and boiling in the range of approximately 150°C to 290°C (320°F to 554°F).
232-366-4
8008-20-6
Asp. Tox. 1
265-667-4
65277-42-1
Repr. 1B; Acute Tox. 3; STOT RE 2
201-196-2
79-33-4
Skin Corr. 1C; Eye Dam. 1
229-352-5
6485-40-1
Skin Sens. 1
215-630-3
1335-32-6
Carc. 2; Repr. 1A; STOT RE 2
237-486-0
13814-96-5
yes
231-846-0
7758-97-6
Carc. 1B; Repr. 1A; STOT RE 2
yes
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77605.
235-759-9
12656-85-8
Carc. 1B; Repr. 1A; STOT RE 2
yes
244-073-9
20837-86-9
yes
206-104-4
301-04-2
Repr. 1A; STOT RE 2
yes
236-542-1
13424-46-9
Unst. Expl.; Repr. 1A; Acute Tox. 4; STOT RE 2
236-542-1
13424-46-9
yes
236-542-1
13424-46-9
Expl. 1.1; Repr. 1A; Acute Tox. 4; STOT RE 2
233-245-9
10099-74-8
yes
229-335-2
6477-64-1
yes
247-278-1
25808-74-6
Repr. 1A; Acute Tox. 4; STOT RE 2
232-064-2
7784-40-9
Carc. 1A; Repr. 1A; Acute Tox. 3; STOT RE 2
yes
215-267-0
1317-36-8
yes
234-853-7
12036-76-9
yes
231-100-4
7439-92-1
Repr. 1A; Lact.
yes
239-290-0
15245-44-0
Unst. Expl.; Repr. 1A; Acute Tox. 4; STOT RE 2
239-290-0
15245-44-0
yes
239-290-0
15245-44-0
Expl. 1.1; Repr. 1A; Acute Tox. 4; STOT RE 2
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77603.
215-693-7
1344-37-2
Carc. 1B; Repr. 1A; STOT RE 2
yes
235-038-9
12060-00-3
yes
235-727-4
12626-81-2
yes
218-499-0
2164-08-1
Carc. 2
244-472-8
21609-90-5
Acute Tox. 3; STOT SE 1; Acute Tox. 4
204-961-9
129-73-7
Carc. 2; Muta. 2
204-811-2
126-91-0
Skin Sens. 1B
The volatile organic liquid extracted from the gas evolved in the high temperature (greater than 700°C (1292°F)) destructive distillation of coal. Composed primarily of benzene, toluene, and xylenes. May contain other minor hydrocarbon constituents.
266-012-5
65996-78-3
Carc. 1B; Muta. 1B
The volatile organic liquid condensed from the gas evolved in the low-temperature (less than 700°C (1292°F)) destructive distillation of coal. Composed primarily of C6-10 hydrocarbons.
292-635-7
90641-11-5
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons obtained by the fractional distillation of petroleum. This fraction boils in a range of approximately 20°C to 135°C (58°F to 275°F).
232-453-7
8032-32-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
201-134-4
78-70-6
Skin Sens. 1B
200-401-2
58-89-9
Acute Tox. 3; Acute Tox. 4; STOT RE 2; Lact.
206-356-5
330-55-2
Repr. 1B; Carc. 2; Acute Tox. 4; STOT RE 2
231-102-5
7439-93-2
Water-react. 1; Skin Corr. 1B

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