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 04 listopada 2024. Database contains 4917 unique substances/entries.
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Product obtained from recycling of the end electrolyte of copper refining electrolysis followed by evaporation to separate the residual sulfuric acid. Consists primarily of nickel and iron sulfates with small amounts of the sulfates of zinc, alkali earths and alkali metals.
295-859-3
92129-57-2
Carc. 1A; Muta. 2; Repr. 1B; STOT RE 1; Acute Tox. 4; Skin Irrit. 2; Resp. Sens. 1; Skin Sens. 1
Details
A complex combination of hydrocarbons obtained from sulfur-containing paraffinic crude oil. It consists predominantly of a solvent refined deparaffinated lubricating oil with a viscosity of 65cSt at 50°C.
295-810-6
92129-09-4
Carc. 1B
Details
A complex combination of hydrocarbons produced by the distillation of a cut from the catalytic cracking process, having undergone an alkaline washing. It consists predominantly of hydrocarbons having carbon numbers in the range of C8 through C12 and boiling in the range of approximately 130°C to 210°C (266°F to 410°F).
295-794-0
92128-94-4
Carc. 1B; Muta. 1B; Asp. Tox. 1
Details
295-551-9
92062-36-7
Carc. 1B; Muta. 1B
Details
The combination of wastes formed by the coking of bituminous coal tar pitch. It consists predominantly of carbon.
295-549-8
92062-34-5
Carc. 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
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
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 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
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

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