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 Please note that Regulation (EU) 2017/745 on medical devices has repealed Directive 90/385/EEC and begun to apply from 26 May 2021.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 28 March 2024. Database contains 4753 unique substances/entries.
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A complex combination of hydrocarbons from the distillation of the products from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C15 through C36 and boiling in the range of approximately 260°C to 480°C (500°F to 896°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-082-4
64741-81-7
Carc. 1B
A complex combination of hydrocarbons obtained by the subjection of a petroleum fraction to several of the following steps: filtration, centrifugation, atmospheric distillation, vacuum distillation, acidification, neutralization, and clay treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C10 through C20.
292-615-8
90640-93-0
Carc. 1B
A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. 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).
265-149-8
64742-47-8
Asp. Tox. 1
A complex combination of hydrocarbons obtained by the solvent treatment of a distillate from hydrocracked petroleum distillates. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C18 through C27 and boiling in the range of approximately 370°C to 450°C (698°F to 842°F).
307-010-7
97488-73-8
Carc. 1B
A complex combination of liquid hydrocarbons obtained by recrystallization of dewaxed hydrocracked solvent-refined petroleum distillates.
295-306-6
91995-45-8
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 treatment of heavy catalytic cracked distillates with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C35 and boiling in the range of approximately 260°C to 500°C (500°F to 932°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
269-784-1
68333-28-8
Carc. 1B
A complex combination of hydrocarbons obtained by treating intermediate catalytic cracked distillates with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists of hydrocarbons having carbon numbers predominantly in the range of C11 through C30 and boiling in the range of approximately 205°C to 450°C (401°F to 842°F). It contains a relatively large proportion of tricyclic aromatic hydrocarbons.
269-783-6
68333-27-7
Carc. 1B
A complex combination of hydrocarbons obtained by treating light catalytic cracked distillates 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 C25 and boiling in the range of approximately 150°C to 400°C (302°F to 752°F). It contains a relatively large proportion of bicyclic aromatic hydrocarbons.
269-781-5
68333-25-5
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 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 C11 through C25 and boiling in the range of approximately 205°C to 400°C (401°F to 752°F).
265-183-3
64742-80-9
Carc. 1B
A complex combination of hydrocarbons obtained by fractionation from hydrodesulfurized thermal cracker distillate stocks. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C11 to C25 and boiling in the range of approximately 205° C to 400°C (401°F to 752°F).
285-505-6
85116-53-6
Carc. 1B
A complex combination of hydrocarbons obtained by distillation of the products from a heavy naphtha hydrotreating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C3 through C6 and boiling in the range of approximately -49°C to 68°C (-57°F to 155°F).
270-094-8
68410-98-0
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil of at least 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-155-0
64742-52-5
Carc. 1B
A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil of at least 100 SUS at 100°F (19cSt at 40°C). It contains a relatively large proportion of saturated hydrocarbons.
265-157-1
64742-54-7
Carc. 1B
A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-156-6
64742-53-6
Carc. 1B
A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C). It contains a relatively large proportion of saturated hydrocarbons.
265-158-7
64742-55-8
Carc. 1B
A complex combination of hydrocarbons obtained by the distillation of products from a middle distillate hydrotreating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C5 through C10 and boiling in the range of approximately 127°C to 188°C (262°F to 370°F).
270-092-7
68410-96-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by treating a petroleum fraction with hydrogen in the presence of a catalyst. It consists of hydrocarbons having carbon numbers predominantly in the range of C11 through C25 and boiling in the range of approximately 205°C to 400°C (401°F to 752°F).
265-148-2
64742-46-7
Carc. 1B
A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process which has been used as a heat transfer fluid. It consists predominantly of hydrocarbons boiling in the range of approximately 220°C to 450°C (428°F to 842°F). This stream is likely to contain organic sulfur compounds.
295-990-6
92201-59-7
Carc. 1B
A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly in the range of C11 through C30 and boiling in the range of approximately 205°C to 450°C (401°F to 842°F). It contains a relatively large proportion of tricyclic aromatic hydrocarbons.
265-062-5
64741-60-2
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 produced by the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C14 through C42 and boiling in the range of approximately 250°C to 545°C (482°F to 1013°F). This stream is likely to contain 5 wt.% or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
274-683-0
70592-76-6
Carc. 1B
The complex combination of hydrocarbons from the distillation of the products from the thermal cracking of ethane and propane. This lower boiling fraction consists predominantly of C5-C7 aromatic hydrocarbons with some unsaturated aliphatic hydrocarbons having a carbon number predominantly of C5. This stream may contain benzene.
267-565-5
67891-80-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process which has been used as a heat transfer fluid. It consists predominantly of hydrocarbons boiling in the range of approximately 190°C to 340°C (374°F to 644°F). This stream is likely to contain organic sulfur compounds.
295-991-1
92201-60-0
Carc. 1B
A complex combination of hydrocarbons produced by the distillation of products from a catalytic cracking process. It consists 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). It contains a relatively large proportion of bicyclic aromatic hydrocarbons.
265-060-4
64741-59-9
Carc. 1B
A complex combination of hydrocarbons obtained by the distillation of products from the light distillate hydrotreating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C6 through C9 and boiling in the range of approximately 3°C to 194°C (37°F to 382°F).
270-093-2
68410-97-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons from distillation of the products from a hydrocracking process. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C10 through C18, and boiling in the range of approximately 160°C to 320°C (320°F to 608°F).
265-078-2
64741-77-1
Carc. 2
A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-053-6
64741-52-2
Carc. 1A
A complex combination of hydrocarbons produced by vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C). It contains a relatively large proportion of saturated aliphatic hydrocarbons normally present in this distillation range of crude oil.
265-051-5
64741-50-0
Carc. 1A
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 C3 through C6.
272-931-2
68921-08-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by the distillation of products from a thermal cracking process. It consists predominantly of aromatic hydrocarbons, primarily benzene.
273-266-0
68955-29-3
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons from the distillation of the products from a thermal cracking process. It consists predominantly of unsaturated hydrocarbons having carbon numbers predominantly in the range of C10 through C22 and boiling in the range of approximately 160°C to 370°C (320°F to 698°F).
265-084-5
64741-82-8
Carc. 1B
A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from atmospheric distillation of crude oil. It consists of hydrocarbons having carbon numbers predominantly in the range of C11 through C35 and boiling in the range of approximately 250°C to 545°C (482°F to 1013°F).
274-684-6
70592-77-7
Carc. 1B
A complex combination of hydrocarbons obtained by treating a light distillate from steam-cracked naphtha. It consists predominantly of aromatic hydrocarbons.
295-311-3
91995-50-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained as the raffinates from a solvent extraction process of hydrotreated light distillate from steam-cracked naphtha.
295-315-5
91995-53-8
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by stripping the products from the naphtha unifiner. It consists of saturated aliphatic hydrocarbons having carbon numbers predominantly in the range of C2 through C6.
272-932-8
68921-09-5
Carc. 1B; Muta. 1B; Asp. Tox. 1
The complex combination of hydrocarbons obtained by the pyrolysis fractionation at 816°C (1500°F) of naphtha and raffinate. It consists predominantly of hydrocarbons having a carbon number of C9 and boiling at approximately 204°C (400°F).
270-344-6
68425-29-6
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons produced by the vacuum distillation of the residuum from the atmospheric distillation of crude oil.
273-263-4
68955-27-1
Carc. 1B
A complex combination of hydrocarbons obtained from the distillation of polymerized steam-cracked petroleum distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C12.
270-735-1
68477-50-9
Carc. 1B; Muta. 1B; Asp. Tox. 1
A complex combination of hydrocarbons obtained by treating dewaxed heavy paraffinic distillate with neutral or modified clay in either a contacting or percolation process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50.
292-616-3
90640-94-1
Carc. 1B
A complex combination of hydrocarbons resulting from treatment of dewaxed light paraffinic distillate with natural or modified clay in either a contacting or percolation process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30.
292-618-4
90640-96-3
Carc. 1B
A complex combination of hydrocarbons produced by treating a dewaxed light paraffinic distillate with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30.
292-620-5
90640-97-4
Carc. 1B
A complex combination of hydrocarbon obtained by removal of normal paraffins from a petroleum fraction by solvent crystallization. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil of not less than 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-167-6
64742-63-8
Carc. 1B
A complex combination of hydrocarbons obtained by removal of normal paraffins from a petroleum fraction by solvent crystallization. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity not less than 100 SUS at 100°F (19cSt at 40°C).
265-169-7
64742-65-0
Carc. 1B
A complex combination of hydrocarbons obtained by removal of normal paraffins from a petroleum fraction by solvent crystallization. It consists of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-168-1
64742-64-9
Carc. 1B
A complex combination of hydrocarbons obtained by removal of normal paraffins from a petroleum fraction by solvent crystallization. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C30 and produces a finished oil with a viscosity of less than 100 SUS at 100°F (19cSt at 40°C).
265-159-2
64742-56-9
Carc. 1B
A complex combination of hydrocarbons obtained as the raffinate from a solvent extraction process. It consists of hydrocarbons having carbon numbers predominantly in the range of C20 through C50 and produces a finished oil with a viscosity of at least 100 SUS at 100°F (19cSt at 40°C). It contains relatively few normal paraffins.
265-097-6
64741-96-4
Carc. 1B

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