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).

RELEVANT LEGISLATION
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Extracts (petroleum), heavy paraffinic distillate solvent, clay-treated; Distillate aromatic extract (treated) [A complex combination of hydrocarbons resulting from treatment of a petroleum fraction with natural or modified clay in either a contact or percolation process to remove the trace amounts of polar compounds and impurities present. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50. This stream is likely to contain 5 wt.% or more 4-6 membered ring aromatic hydrocarbons.]

A complex combination of hydrocarbons resulting from treatment of a petroleum fraction with natural or modified clay in either a contact or percolation process to remove the trace amounts of polar compounds and impurities present. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C20 through C50. This stream is likely to contain 5 wt. % or more 4-6 membered ring aromatic hydrocarbons. EC / List no: 296-437-1 CAS no: 92704-08-0
EU CLP (1272/2008)
Carc. 1B