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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Tar acids, distn. residues; Distillate Phenols [A residue from the distillation of crude phenol from coal. It consists predominantly of phenols having carbon numbers in the range of C8 through C10 with a softening point of 60 °C to 80 °C (140°F to 176°F).]

A residue from the distillation of crude phenol from coal. It consists predominantly of phenols having carbon numbers in the range of C8 through C10 with a softening point of 60°C to 80°C (140°F to 176°F). EC / List no: 306-251-5 CAS no: 96690-55-0
EU CLP (1272/2008)
Carc. 1B; Muta. 1B