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).

Tar acids, brown-coal, C2-alkylphenol fraction; Distillate Phenols [The distillate from the acidification of alkaline washed lignite tar distillate boiling in the range of approximately 200 °C to 230 °C (392°F to 446°F). Composed primarily of m-and p-ethylphenol as well as cresols and xylenols.]

The distillate from the acidification of alkaline washed lignite tar distillate boiling in the range of approximately 200°C to 230°C (392°F to 446°F). Composed primarily of m- and p-ethylphenol as well as cresols and xylenols. EC / List no: 302-662-9 CAS no: 94114-29-1
EU CLP (1272/2008)
Carc. 1B; Muta. 1B