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), heavy paraffinic distillate solvent, hydrotreated; Distillate aromatic extract (treated) [A complex combination of hydrocarbons produced by treating a heavy paraffinic distillate solvent extract with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C21 through C33 and boiling in the range of approximately 350°C to 480°C (662°F to 896°F).

A complex combination of hydrocarbons produced by treating a heavy paraffinic distillate solvent extract with hydrogen in the presence of a catalyst. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C21 through C33 and boiling in the range of approximately 350°C to 480°C (662°F to 896°F). EC / List no: 292-632-0 CAS no: 90641-08-0
EU CLP (1272/2008)
Carc. 1B