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 oils (coal), coal tar-residual pyrolysis oils, naph thalene oil, redistillate; Redistillates [The redistillate from the fractional distillation of dephe nolated and debased methylnaphthalene oil obtained from bituminous coal high temperature tar and pyrolysis residual oils boiling in the approximate range of 220o C to 230o C (428°F to 446°F). It consists predominantly of unsubstituted and substituted dinuclear aromatic hydrocarbons.]

The redistillate from the fractional distillation of dephenolated and debased methylnaphthalene oil obtained from bituminous coal high temperature tar and pyrolysis residual oils boiling in the approximate range of 220°C to 230°C (428°F to 446°F). It consists predominantly of unsubstituted and substituted dinuclear aromatic hydrocarbons. EC / List no: 295-329-1 CAS no: 91995-66-3
EU CLP (1272/2008)
Carc. 1B; Muta. 1B