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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Hydrocarbons, C13-27, solvent-extd. light naphthenic; Baseoil — unspecified [A complex combination of hydrocarbons obtained by extraction of the aromatics from a light naphthenic distillate having a viscosity of 9.5cSt at 40 °C (104 °F). It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C13 through C27 and boiling in the range of approximately 240 °C to 400 °C (464 °F to 752 °F).]

A complex combination of hydrocarbons obtained by extraction of the aromatics from a light naphthenic distillate having a viscosity of 9.5cSt at 40°C (104°F). It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C13 through C27 and boiling in the range of approximately 240°C to 400°C (464°F to 752°F). EC / List no: 307-758-4 CAS no: 97722-09-3
EU CLP (1272/2008)
Carc. 1B