EU-MEDICAL_DEVICES_REGULATION-ANX_I_SEC_10

Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Medical Devices Regulation 2017/745/EU, 5 May 2017, as amended by Regulation 2020/561/EU, 24 April 2020

This list contains hazardous substances for purposes of the Medical Devices Regulation (MDR), based on the legislation's Annex I general safety and performance requirements, including for chemical, physical and biological properties. Specifically, the 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).

Last updated 23 svibnja 2024. Database contains 4917 unique substances/entries.
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A complex combination of hydrocarbons obtained from mixed coal tar pitch-polystyrene pyrolysis. Composed primarily of polycyclic aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C28 and having a softening point of 100°C to 220°C (212°F to 428°F) according to DIN 52025.
309-958-7
101794-76-7
Carc. 1B
Details
200-280-6
56-55-3
Carc. 1B
C Carcinogenic (article 57a)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
205-911-9
205-99-2
Carc. 1B
Details
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-
Carc. 1B
Details
205-892-7
192-97-2
Carc. 1B
Details
205-910-3
205-82-3
Carc. 1B
Details
205-916-6
207-08-9
Carc. 1B
C Carcinogenic (article 57a)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
204-337-6
119-61-9
Carc. 1B
Details
A complex combination of hydrocarbons produced as the residual fraction from distillation of the products from a catalytic cracking process. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
265-064-6
64741-62-4
Carc. 1B
Details
A complex combination of hydrocarbons obtained by treating catalytic cracked clarified oil with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists of hydrocarbons having carbon numbers predominantly greater than C20 and boiling above approximately 350°C (662°F). This stream is likely to contain 5 wt. % or more of 4- to 6-membered condensed ring aromatic hydrocarbons.
269-782-0
68333-26-6
Carc. 1B
Details
The substantially solvent-free product obtained by the distillation of the solvent from filtered coal extract solution produced by digesting coal in a liquid solvent. A black semi-solid, composed primarily of a complex combination of condensed-ring aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic compounds and other aromatic oxygen compounds, and their alkyl derivatives.
302-683-3
94114-48-4
Carc. 1B
Details
The product obtained by filtration of coal mineral matter and undissolved coal from coal extract solution produced by digesting coal in a liquid solvent. A black, viscous, highly complex liquid combination composed primarily of aromatic and partly hydrogenated aromatic hydrocarbons, aromatic nitrogen compounds, aromatic sulfur compounds, phenolic and other aromatic oxygen compounds and their alkyl derivatives.
302-682-8
94114-47-3
Carc. 1B
Details
The distillate of coal tar produced by the high temperature carbonization of bituminous coal. It consists primarily of aromatic hydrocarbons, tar acids and tar bases.
232-287-5
8001-58-9
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists primarily of aromatic hydrocarbons and may contain appreciable quantities of tar acids and tar bases. It distills at the approximate range of 200°C to 325°C (392°F to 617°F).
263-047-8
61789-28-4
Carc. 1B
Details
The oil remaining after removal by a crystallization process of acenaphthene from acenaphthene oil from coal tar. Composed primarily of naphthalene and alkylnaphthalenes.
292-606-9
90640-85-0
Carc. 1B
Details
A complex combination of hydrocarbons produced by the distillation of coal tar and boiling in the range of approximately 240°C to 280°C (464°F to 536°F). Composed primarily of acenaphthene, naphthalene and alkyl naphthalene.
292-605-3
90640-84-9
Carc. 1B
Details
The high-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillates, removed. It is crystal free at approximately 5°C (41°F).
274-565-9
70321-79-8
Carc. 1B
Details
The low-boiling distillation fraction obtained from the high temperature carbonization of bituminous coal, which is further refined to remove excess crystalline salts. It consists primarily of creosote oil with some of the normal polynuclear aromatic salts, which are components of coal tar distillate, removed. It is crystal free at approximately 38°C (100°F).
274-566-4
70321-80-1
Carc. 1B
Details
206-382-7
334-88-3
Carc. 1B
Details
200-181-8
53-70-3
Carc. 1B
Details
240-221-1
16071-86-6
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the distillation of coal tar. It consists of hydrocarbons having carbon numbers primarily in the range of C4 to C10 and distilling in the approximate range of 80°C to 160°C (175°F to 320°F).
283-482-7
84650-02-2
Carc. 1B
Details
The redistillate obtained from the fractional distillation of pitch distillate boiling in the range of approximately 350°C to 400°C (662°F to 752°F). Consists predominantly of tri- and polynuclear aromatics and heterocyclic hydrocarbons.
295-304-5
91995-42-5
Carc. 1B
Details
Distillate from the fractional distillation of coal tar of bituminous coal, with boiling range of 240°C to 400°C (464°F to 752°F). Composed primarily of tri- and polynuclear hydrocarbons and heterocyclic compounds.
292-607-4
90640-86-1
Carc. 1B
Details
The distillate from the distillation of the pitch obtained from bituminous high temperature tar. Composed primarily of tri- and polynuclear aromatic hydrocarbons and boiling in the range of approximately 300°C to 470°C (572°F to 878°F). The product may also contain heteroatoms.
295-312-9
91995-51-6
Carc. 1B
Details
The redistillate obtained from the fractional distillation of pitch distillate and boiling in the range of approximately 380°C to 410°C (716°F to 770°F). Composed primarily of tri- and polynuclear aromatic hydrocarbons and heterocyclic compounds.
295-313-4
91995-52-7
Carc. 1B
Details
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
Details
A complex combination of hydrocarbons obtained by the crystallization of the fractional distillates from tar oil. It consists of aromatic polycyclic hydrocarbons, primarily diphenyl, dibenzofuran and acenaphthene.
284-899-7
84989-10-6
Carc. 1B
Details
A complex combination of hydrocarbons obtained by the crystallization of the fractional distillates from coal tar. It consists of aromatic and polycyclic hydrocarbons, primarily fluorene and acenaphthene.
284-900-0
84989-11-7
Carc. 1B
Details
The distillate from coal tar having an approximate distillation range of 220°C to 450°C (428°F to 842°F). Composed primarily of three to four membered condensed ring aromatic hydrocarbons and other hydrocarbons.
266-026-1
65996-91-0
Carc. 1B
Details
The distillate from coal tar having an approximate distillation range of 100°C to 450°C (212°F to 842°F). Composed primarily of two to four membered condensed ring aromatic hydrocarbons, phenolic compounds, and aromatic nitrogen bases.
266-027-7
65996-92-1
Carc. 1B
Details
The distillate from a mixture of coal tar and aromatic petroleum streams having an approximate distillation range of 220°C to 450°C (428°F to 842°F). Composed primarily of 3- to 4-membered condensed ring aromatic hydrocarbons.
269-159-3
68188-48-7
Carc. 1B
Details
A complex combination of hydrocarbons obtained from the distillation of a catalytically reformed petroleum cut. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C10 through C16 and boiling in the range of approximately 200°C to 300°C (392°F to 572°F).
295-294-2
91995-34-5
Carc. 1B
Details
A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. 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).
265-114-7
64742-14-9
Carc. 1B
Details
A complex combination of hydrocarbons obtained as a raffinate from a sulfuric acid treating process. It consists of hydrocarbons having carbon numbers predominantly in the range of C11 through C20 and boiling in the range of approximately 205°C to 345°C (401°F to 653°F).
265-113-1
64742-13-8
Carc. 1B
Details
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
Details
A complex combination of hydrocarbons from the distillation of catalytic reformer fractionator residue. It boils in the range of approximately 343°C to 399°C (650°F to 750°F).
270-719-4
68477-29-2
Carc. 1B
Details
A complex combination of hydrocarbons from the distillation of catalytic reformer fractionator residue. It boils in the range of approximately 288°C to 371°C (550°F to 700°F).
270-721-5
68477-30-5
Carc. 1B
Details
The complex combination of hydrocarbons from the distillation of catalytic reformer fractionator residue. It boils approximately below 288°C (550°F).
270-722-0
68477-31-6
Carc. 1B
Details
A complex combination of hydrocarbons produced by a treating process to remove acidic materials. It consists of hydrocarbons having carbon numbers predominantly in the range of C11 through C20 and boiling in the range of approximately 205°C to 345°C (401°F to 653°F).
265-130-4
64742-30-9
Carc. 1B
Details
A complex combination of hydrocarbons resulting from treatment of a petroleum fraction with natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. 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.
265-146-1
64742-44-5
Carc. 1B
Details
A complex combination of hydrocarbons resulting from treatment of a petroleum fraction with natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. 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.
265-147-7
64742-45-6
Carc. 1B
Details
A complex combination of hydrocarbons resulting from treatment of a petroleum fraction with natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. 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.
265-138-8
64742-37-6
Carc. 1B
Details
A complex combination of hydrocarbons resulting from treatment of a petroleum fraction with natural or modified clay, usually in a percolation process to remove the trace amounts of polar compounds and impurities present. It consists of hydrocarbons having carbon numbers predominantly in the range of C9 through C20 and boiling in the range of approximately 150°C to 345°C (302°F to 653°F).
265-139-3
64742-38-7
Carc. 1B
Details
A complex combination of hydrocarbons resulting from treatment of a petroleum fraction with natural or modified clay in either a contacting or percolation process to remove the trace amounts of polar compounds and impurities present. 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 a relatively large proportion of saturated hydrocarbons.
265-137-2
64742-36-5
Carc. 1B
Details
A complex combination of hydrocarbons obtained by dewaxing heavy paraffinic distillate. It consists predominantly of hydrocarbons having carbon numbers predominantely in the range of C20 through C50 and produces a finished oil with a viscosity of equal to or greater than 100 SUS at 100°F (19cST at 40°C). It contains relatively few normal paraffins.
292-613-7
90640-91-8
Carc. 1B
Details
A complex combination of hydrocarbons obtained by dewaxing light paraffinic distillate. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C12 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.
292-614-2
90640-92-9
Carc. 1B
Details
A complex combination of hydrocarbons obtained by distilling cracked steam cracked distillate and/or its fractionation products. It consists of hydrocarbons having carbon number predominantly in the range of C10 to low molecular weight polymers.
270-727-8
68477-38-3
Carc. 1B
Details
A complex combination of hydrocarbons obtained from an intensive treatment of dewaxed distillate by hydrogenation in the presence of a catalyst. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C25 through C39 and produces a finished oil with a viscosity of approximately 44cSt at 50°C.
295-300-3
91995-39-0
Carc. 1B
Details
A complex combination of hydrocarbons obtained from an intensive treatment of dewaxed distillate by hydrogenation in the presence of a catalyst. It consists predominantly of saturated hydrocarbons having carbon numbers predominantly in the range of C21 through C29 and produces a finished oil with a viscosity of approximately 13cSt at 50°C.
295-301-9
91995-40-3
Carc. 1B
Details

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