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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Naphtha (petroleum), light catalytic reformed, arom.-free; Low boiling point cat-reformed naphtha [A complex combination of hydrocarbons obtained from distillation of products from a catalytic reforming process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C8 and boiling in the range of approxi mately 35o C to 120o C (95 °F to 248 °F). It contains a relatively large proportion of branched chain hydrocarbons with the aromatic components removed.]

A complex combination of hydrocarbons obtained from distillation of products from a catalytic reforming process. It consists predominantly of hydrocarbons having carbon numbers predominantly in the range of C5 through C8 and boiling in the range of approximately 35°C to 120°C (95°F to 248°F). It contains a relatively large proportion of branched chain hydrocarbons with the aromatic components removed. EC / List no: 270-993-5 CAS no: 68513-03-1
EU CLP (1272/2008)
Carc. 1B; Muta. 1B; Asp. Tox. 1