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).

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Extracts (petroleum), solvent-dewaxed heavy paraffinic distillate solvent, hydrodesulfurized; Distillate aromatic extract (treated) [A complex combination of hydrocarbons obtained from a solvent dewaxed petroleum stock by treating with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C50 and produces a finished oil with a viscosity of greater than 19cSt at 40 °C.]

A complex combination of hydrocarbons obtained from a solvent dewaxed petroleum stock by treating with hydrogen to convert organic sulfur to hydrogen sulfide which is removed. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C15 through C50 and produces a finished oil with a viscosity of greater than 19cSt at 40°C. EC / List no: 297-829-5 CAS no: 93763-11-2
EU CLP (1272/2008)
Carc. 1B