EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998

This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. It 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). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

Last updated 15 srpnja 2024. Database contains 4821 unique substances/entries.
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A complex combination obtained from the flash drum of the unit treating sour kerosine with hydrogen in the presence of a catalyst. It consists primarily of hydrogen and methane with various small amounts of nitrogen, carbon monoxide, and hydrocarbons having carbon numbers predominantly in the range of C2 through C5.
272-776-0
68911-59-1
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination obtained from recycled hydrotreated blend oil. It consists primarily of hydrogen and nitrogen with various small amounts of carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
270-781-2
68477-98-5
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
270-782-8
68477-99-6
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained by the fractionation of light straight-run gasoline. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
272-878-5
68919-05-1
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons obtained by the stabilization of light straight-run naphtha. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C6.
271-002-9
68513-17-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination obtained as a mixture of the non-condensable portions from the product of a naphtha steam cracking process as well as residual gases obtained during the preparation of subsequent products. It consists predominantly of hydrogen and paraffinic and olefinic hydrocarbons having carbon numbers predominantly in the range of C1 through C5 with which natural gas may also be mixed.
295-401-2
92045-19-7
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination of hydrocarbons produced by a naphtha unifiner desulfurization process and stripped from the naphtha product. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C4.
272-879-0
68919-06-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination separated by distillation of a gas stream containing hydrogen, carbon monoxide, carbon dioxide and hydrocarbons having carbon numbers in the range of C1 through C6 or obtained by cracking ethane and propane. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C2, hydrogen, nitrogen, and carbon monoxide.
271-258-1
68527-15-1
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination obtained from the chemical reforming of naphthenes to aromatics. It consists of hydrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C4.
272-343-6
68814-90-4
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination obtained by the fractionation of the light ends of the platinum reactors of the platformer unit. It consists of hydrogen, methane, ethane, and propane.
272-880-6
68919-07-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination produced from the first tower used in the distillation of crude oil. It consists of nitrogen and saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
272-881-1
68919-08-4
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination obtained from recycled reactor gases. It consists primarily of hydrogen with various small amounts of carbon monoxide, carbon dioxide, nitrogen, hydrogen sulfide, and saturated aliphatic hydrocarbons having carbon numbers in the range of C1 through C5.
270-783-3
68478-00-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
A complex combination obtained from various refinery processes. It consists of hydrogen, hydrogen sulfide and hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
272-183-7
68783-07-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
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 obtained from viscosity reduction of residues in a furnace. It consists predominantly of hydrogen sulfide and paraffinic and olefinic hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
295-402-8
92045-20-0
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 produced by the distillation of products from a steam cracking process. It consists predominantly of propylene with some propane and boils in the range of approximately minus 70°C to 0°C (minus 94°F to 32°F).
295-404-9
92045-22-2
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 high octane combination of hydrocarbons obtained by the catalytic dehydrogenation of a predominantly naphthenic naphtha. It consists predominantly of aromatics and non-aromatics having carbon numbers predominantly in the range of C5 through C11 and boiling in the range of approximately 45°C to 185°C (113°F to 365°F).
297-458-9
93572-29-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
Motor fuel produced by the reforming of the refined naphtha fraction of the products of hydrocracking of coal extract or solution produced by the liquid solvent extraction or supercritical gas extraction processes and boiling in the range of approximately 30°C to 180°C (86°F to 356°F). Composed primarily of aromatic and naphthenic hydrocarbons, their alkyl derivatives and alkyl hydrocarbons having carbon numbers in the range of C4 through C9.
302-691-7
94114-55-3
Carc. 1B
A complex combination of hydrocarbons separated from natural gas by processes such as refrigeration or absorption. It consists predominantly of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C4 through C8 and boiling in the range of approximately minus 20°C to 120°C (-4°F to 248°F).
232-349-1
8006-61-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
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 distillation fraction from the hydrogenation of pyrolysis gasoline boiling in the range of approximately 20°C to 200°C (68°F to 392°F).
302-639-3
94114-03-1
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
A complex combination of hydrocarbons consisting primarily of paraffins, cycloparaffins, aromatic and olefinic hydrocarbons having carbon numbers predominantly greater than C3 and boiling in the range of 30°C to 260°C (86°F to 500°F).
289-220-8
86290-81-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
203-377-1
106-24-1
Skin Sens. 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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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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P Parasites
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Carc. 2
232-589-7
9001-22-3
Resp. Sens. 1
278-636-5
77182-82-2
Repr. 1B; Acute Tox. 4; STOT RE 2
EW 400; GLUCOPROTAMIN
403-950-8
164907-72-6
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B
200-240-8
55-63-0
Expl. 1.1; Acute Tox. 2; Acute Tox. 1; STOT RE 2

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