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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Solvent naphtha (coal); Light Oil Extract Residues, high boiling [The distillate from either high temperature coal tar, coke oven light oil, or coal tar oil alkaline extract residue having an approximate distillation range of 130o C to 210o C (266oF to 410oF). Composed primarily of indene and other polycyclic ring systems containing a single aromatic ring. May contain phenolic compounds and aromatic nitrogen bases.]

The distillate from either high temperature coal tar, coke oven light oil, or coal tar oil alkaline extract residue having an approximate distillation range of 130°C to 210°C (266°F to 410°F) Composed primarily of indene and other polycyclic ring systems containing a single aromatic ring. May contain phenolic compounds and aromatic nitrogen bases. EC / List no: 266-013-0 CAS no: 65996-79-4
EU CLP (1272/2008)
Carc. 1B; Muta. 1B