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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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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A complex combination obtained from various petroleum refining operations. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C3.
272-338-9
68814-67-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination produced by the high-pressure flashing of the effluent from the reforming reactor. It consists primarily of hydrogen with various small amounts of methane, ethane, and propane.
271-003-4
68513-18-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination produced by low-pressure flashing of the effluent from the reforming reactor. It consists primarily of hydrogen with various small amounts of methane, ethane, and propane.
271-005-5
68513-19-9
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination obtained from the reformers. It consists primarily of hydrogen with various small amounts of carbon monoxide and aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
270-784-9
68478-01-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination obtained from the reforming hydrotreating process. It consists primarily of hydrogen with various small amounts of carbon monoxide and aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
270-788-0
68478-04-6
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination obtained from the reforming hydrotreating process. It consists primarily of hydrogen and methane with various small amounts of carbon monoxide, carbon dioxide, nitrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C5.
270-787-5
68478-03-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination obtained from the reforming hydrotreating process. It consists primarily of hydrogen, methane, and ethane with various small amounts of hydrogen sulfide and aliphatic hydrocarbons having carbon numbers predominantly in the range of C3 through C5.
270-785-4
68478-02-4
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination produced by the fractionation of the overhead products from the catalytic cracking process in the fluidized catalytic cracker. It consists of hydrogen, nitrogen, and hydrocarbons having carbon numbers predominantly in the range of C1 through C3.
271-625-6
68602-84-6
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination obtained by the fractionation of products from the fluidized catalytic cracker and gas oil desulfurizer. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
273-269-7
68955-33-9
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha and the fractionation of the total effluent. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C4.
273-270-2
68955-34-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained by the catalytic reforming of straight-run naphtha and fractionation of the total effluent. It consists of methane, ethane, and propane.
272-882-7
68919-09-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from the fractionation of the liquid from the first tower used in the distillation of crude oil. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
272-883-2
68919-10-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination obtained by the fractionation of reduced crude oil. It consists of hydrogen and hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
272-884-8
68919-11-9
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination produced by distillation of products from a thermal cracking process. It consists of hydrogen, hydrogen sulfide, carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
270-789-6
68478-05-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A combination of hydrogen and methane obtained by fractionation of the products from the unifiner unit.
272-885-3
68919-12-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons produced by the distillation of products from a thermal cracking process. It consists of hydrocarbons having a carbon number predominantly of C4.
273-265-5
68955-28-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons produced by the fractionation of the charge to the C3-C4 splitter. It consists predominantly of C3 hydrocarbons.
272-893-7
68919-20-0
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons produced by the atmospheric distillation of a butane-butylene stream. It consists of aliphatic hydrocarbons having carbon numbers predominantly in the range of C3 through C4.
270-769-7
68477-87-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained from the fractionation of depropanizer bottoms. It consists of hydrocarbons having carbon numbers predominantly greater than C5.
271-726-5
68606-10-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced from the topping plant by the distillation of crude oil. It boils in the range of approximately 36.1°C to 193.3°C (97°F to 380°F).
271-727-0
68606-11-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons separated from the gases from vapor recovery systems by cooling. It consists of hydrocarbons having carbon numbers predominantly in the range of C4 through C11 and boiling in the range of approximately -20°C to 196°C(-4°F to 384°F).
271-025-4
68514-15-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
211-653-8
680-31-9
Carc. 1B; Muta. 1B
A complex combination of hydrocarbons having carbon numbers predominantly in the range of C1 through C3 and boiling in the range of approximately minus 164°C to minus 42°C (-263°F to -44°F).
271-259-7
68527-16-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
271-261-8
68527-19-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained by subjecting hydrocarbon gases to a sweetening process to convert mercaptans or to remove acidic impurities. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C4 and boiling in the range of approximately -164°C to -0.5°C(-263°F to 31°F).
271-038-5
68514-36-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons produced by thermal cracking and absorber operations and by distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C4 and boiling in the range of approximately minus 164°C to minus 0.5°C (-263°F to 31°F).
271-032-2
68514-31-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-689-2
68476-49-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
271-734-9
68606-25-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-687-1
68476-47-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by the distillations of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C11 and boiling in a range approximately up to 204°C(400°F).
270-686-6
68476-46-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by distillation and condensation of crude oil. It consists of hydrocarbons having carbon numbers in the range of C3 through C5, predominantly C3 through C4.
270-990-9
68512-91-4
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-681-9
68476-40-4
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
271-735-4
68606-26-8
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-682-4
68476-42-6
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-695-5
68476-55-1
Carc. 1B; Muta. 1B; Asp. Tox. 1
270-690-8
68476-50-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
423-310-1
61420-92-6
Acute Tox. 4; STOT RE 2; Skin Corr. 1A; Resp. Sens. 1; Skin Sens. 1
200-590-1
64-69-7
Acute Tox. 3; Skin Corr. 1A
-
696-33-3
Expl.
210-901-2
625-55-8
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
211-300-8
637-78-5
Flam. Liq. 2
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
265-667-4
65277-42-1
Repr. 1B; Acute Tox. 3; STOT RE 2
229-352-5
6485-40-1
Skin Sens. 1
229-335-2
6477-64-1
yes
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
211-057-8
628-86-4
Unst. Expl.; Acute Tox. 3; STOT RE 2
211-057-8
628-86-4
Expl. 1.1; Acute Tox. 3; STOT RE 2
266-583-0
67129-08-2
Skin Sens. 1B; Carc. 2
630-448-8
62610-77-9
Acute Tox. 4; Skin Sens. 1

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