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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Extract residues (coal), benzole fraction alk., acid ext.; Light Oil Extract Residues, low boiling [The redistillate from the distillate, freed of tar acids and tar bases, from bituminous coal high temperature tar boiling in the approximate range of 90o C to 160 o C (194oF to 320 oF). It consists predomi nantly of benzene, toluene and xylenes.]

The redistillate from the distillate, freed of tar acids and tar bases, from bituminous coal high temperature tar boiling in the approximate range of 90°C to 160°C (194°F to 320°F). It consists predominantly of benzene, toluene and xylenes. EC / List no: 295-323-9 CAS no: 91995-61-8
EU CLP (1272/2008)
Carc. 1B; Muta. 1B