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 14 lipnja 2024. Database contains 4917 unique substances/entries.
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A complex combination of hydrocarbons obtained from catalytic hydrodesulfurization of vacuum gas oil and from which hydrogen sulfide has been removed by amine treatment. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C1 through C6.
269-632-4
68308-12-3
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination of hydrocarbons obtained from the thermal cracking of vacuum residues. It consists of hydrocarbons having carbon numbers predominantly in the range of C1 through C5.
270-815-6
68478-34-2
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B
Details
A complex combination derived from tall oil. Composed primarily of tricyclic monocarboxylic acids, mainly abietic and dehydroabietic acids. Includes tall-oil rosin stabilized by catalytic disproportionation.
232-484-6
8052-10-6
Skin Sens. 1
Details
The fraction of tar acids, rich in 3,5-dimethylphenol, recovered by distillation of low-temperature coal tar acids.
284-896-0
84989-07-1
Carc. 1B; Muta. 1B
Details
A complex combination of organic compounds obtained from brown coal gasification. Composed primarily of C6-10 hydroxy aromatic phenols and their homologs.
295-536-7
92062-22-1
Carc. 1B; Muta. 1B
Details
The reaction product obtained by neutralizing coal tar oil alkaline extract with an acidic solution, such as aqueous sulfuric acid, or gaseous carbon dioxide, to obtain the free acids. Composed primarily of tar acids such as phenol, cresols, and xylenols.
266-019-3
65996-85-2
Carc. 1B; Muta. 1B
Details
The residue from crude coal tar acids after removal of phenol, cresols, xylenols and any higher boiling phenols. A black solid with a melting point approximately 80°C (176°F). Composed primarily of polyalkylphenols, resin gums, and inorganic salts.
271-418-0
68555-24-8
Carc. 1B; Muta. 1B
Details
272-361-4
68815-21-4
Carc. 1B; Muta. 1B
Details
A complex combination of organic compounds obtained from brown coal and boiling in the range of approximately 200°C to 230°C (392°F to 446°F). It contains chiefly phenols and pyridine bases.
295-540-9
92062-26-5
Carc. 1B; Muta. 1B
Details
The fraction of tar acids, rich in 3- and 4-ethylphenol, recovered by distillation of low-temperature coal tar crude tar acids.
284-891-3
84989-03-7
Carc. 1B; Muta. 1B
Details
The fraction of tar acid rich in 3- and 4-methylphenol, recovered by distillation of low-temperature coal tar crude tar acids.
284-892-9
84989-04-8
Carc. 1B; Muta. 1B
Details
The fraction of tar acids, recovered by distillation of low-temperature coal tar crude tar acids, having an approximate boiling range of 225°C to 320°C (437°F to 608°F). Composed primarily of polyalkylphenols.
284-893-4
84989-05-9
Carc. 1B; Muta. 1B
Details
The residue from the distillation in the range of 235°C to 355°C (481°F to 697°F) of light carbolic oil.
270-713-1
68477-23-6
Carc. 1B; Muta. 1B
Details
The fraction of tar acids, rich in 2,4- and 2,5-dimethylphenol, recovered by distillation of low-temperature coal tar crude tar acids.
284-895-5
84989-06-0
Carc. 1B; Muta. 1B
Details
The distillation fraction boiling in the range of approximately 180°C to 200°C (356°F to 392°F) from the crude bases obtained by dephenolating and debasing the carbolated oil from the distillation of coal tar. It contains chiefly aniline, collidines, lutidines and toluidines.
295-541-4
92062-27-6
Carc. 1B; Muta. 1B
Details
The distillation fraction boiling in the range of approximately 181°C to 186°C (356°F to 367°F) from the crude bases obtained from the neutralized, acid-extracted base-containing tar fractions obtained by the distillation of bituminous coal tar. It contains chiefly aniline and collidines.
295-543-5
92062-28-7
Carc. 1B; Muta. 1B
Details
The reaction product obtained by neutralizing coal tar base extract oil with an alkaline solution, such as aqueous sodium hydroxide, to obtain the free bases. Composed primarily of such organic bases as acridine, phenanthridine, pyridine, quinoline and their alkyl derivatives.
266-018-8
65996-84-1
Carc. 1B; Muta. 1B
Details
The distillation residue remaining after the distillation of the neutralized, acid-extracted base-containing tar fractions obtained by the distillation of coal tars. It contains chiefly aniline, collidines, quinoline and quinoline derivatives and toluidines.
295-544-0
92062-29-8
Carc. 1B; Muta. 1B
Details
293-766-2
91082-52-9
Carc. 1B; Muta. 1B
Details
Pyridine bases boiling in the range of approximately 125°C to 160°C (257°F 320°F) obtained by distillation of neutralized acid extract of the base-containing tar fraction obtained by the distillation of bituminous coal tars. Composed chiefly of lutidines and picolines.
295-548-2
92062-33-4
Carc. 1B; Muta. 1B
Details
274-560-1
70321-67-4
Carc. 1B; Muta. 1B
Details
293-767-8
91082-53-0
Carc. 1B; Muta. 1B
Details
271-020-7
68513-87-1
Carc. 1B; Muta. 1B
Details
The distillate from high temperature coal tar having an approximate distillation range of 130°C to 250°C (266°F to 410°F). Composed primarily of naphthalene, alkylnaphthalenes, phenolic compounds, and aromatic nitrogen bases.
266-016-7
65996-82-9
Carc. 1B; Muta. 1B
Details
Coke- and ash-containing solid residues that separate on distillation and thermal treatment of bituminous coal high temperature tar in distillation installations and storage vessels. Consists predominantly of carbon and contains a small quantity of hetero compounds as well as ash components.
295-535-1
92062-20-9
Carc. 1B
Details
The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700°C (1292°F)) destructive distillation of coal. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons with a high solid content of coal- and coke-type materials.
273-615-7
68990-61-4
Carc. 1B
Details
The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in the high temperature (greater than 700°C (1292°F)) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of a complex mixture of condensed ring aromatic hydrocarbons. May contain minor amounts of phenolic compounds and aromatic nitrogen bases.
266-024-0
65996-89-6
Carc. 1A
Details
The condensation product obtained by cooling, to approximately ambient temperature, the gas evolved in low temperature (less than 700°C (1292°F)) destructive distillation of coal. A black viscous liquid denser than water. Composed primarily of condensed ring aromatic hydrocarbons, phenolic compounds, aromatic nitrogen bases, and their alkyl derivatives.
266-025-6
65996-90-9
Carc. 1A
Details
The deposit removed from crude coal tar storages. Composed primarily of coal tar and carbonaceous particulate matter.
293-764-1
91082-50-7
Carc. 1B
Details
The by-product from the destructive distillation of coal. Almost black semisolid. A complex combination of aromatic hydrocarbons, phenolic compounds, nitrogen bases and thiophene.
232-361-7
8007-45-2
Carc. 1A
Details
200-927-2
76-03-9
Skin Corr. 1A
Details
211-479-2
650-51-1
STOT SE 3
Details
251-793-7
34014-18-1
Acute Tox. 4
Details
204-178-2
117-18-0
Acute Tox. 4; Skin Sens. 1
Details
236-813-4
13494-80-9
Repr. 1B; Lact.
Details
231-193-1
7446-07-3
Repr. 1B; Lact.
Details
203-495-3
107-49-3
Acute Tox. 1; Acute Tox. 2
Details
235-963-8
13071-79-9
Acute Tox. 1; Acute Tox. 2
Details
251-637-8
33693-04-8
Acute Tox. 4
Details
227-637-9
5915-41-3
Acute Tox. 4; STOT RE 2
Details
262-967-7
61788-32-7
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
262-967-7
61788-32-7
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
208-760-7
540-88-5
Flam. Liq. 2
Details
216-768-7
1663-39-4
Flam. Liq. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Details
212-105-0
762-75-4
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
Details
200-915-7
75-91-2
Muta. 2
Details
216-653-1
1634-04-4
Flam. Liq. 2; Skin Irrit. 2
Details
208-757-0
540-80-7
Flam. Liq. 2; Acute Tox. 4
Details
222-389-8
3457-61-2
Org. Perox. E; Skin Irrit. 2
Details
235-541-3
12267-73-1
Repr. 1B
R Toxic for reproduction (article 57c)
Details

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