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).

Naphtha (petroleum), light thermal cracked, sweetened; Low boiling point thermally cracked naphtha [A complex combination of hydrocarbons obtained by subjecting a petroleum distillate From the high temperature thermal cracking of heavy oil fractions to a sweetening process to convert mercaptans. It consists predominantly of aromatics, olefins and saturated hydrocarbons boiling in the range of approximately 20 °C to 100 °C (68 °F to 212 °F).]

A complex combination of hydrocarbons obtained by subjecting a petroleum distillate from the high temperature thermal cracking of heavy oil fractions to a sweetening process to convert mercaptans. It consists predominantly of aromatics, olefins and saturated hydrocarbons boiling in the range of approximately 20°C to 100°C (68°F to 212°F). EC / List no: 295-447-3 CAS no: 92045-65-3
EU CLP (1272/2008)
Carc. 1B; Muta. 1B; Asp. Tox. 1