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 steam-cracked arom.; Low boiling point naphtha -unspecified [A complex combination of hydrocarbons produced by distillation of products from a steam-cracking process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C9 and boiling in the range of approximately 110o C to 165 o C (230 °F to 329 °F).]

A complex combination of hydrocarbons produced by distillation of products from a steam-cracking process. It consists predominantly of aromatic hydrocarbons having carbon numbers predominantly in the range of C7 through C9 and boiling in the range of approximately 110°C to 165°C (230°F to 329°F). EC / List no: 271-264-4 CAS no: 68527-23-1
EU CLP (1272/2008)
Carc. 1B; Muta. 1B; Asp. Tox. 1