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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Extracts (petroleum), cold-acid, C4-6; Low boiling point naphtha — unspecified [A complex combination of organic compounds produced by cold acid unit extraction of saturated and unsaturated aliphatic hydrocarbons usually ranging in carbon numbers from C3 through C6, predominantly pentanes and amylenes. It consists predominantly of saturated and unsaturated hydrocarbons having carbon numbers in the range of C4 through C6, predominantly C5.]

A complex combination of organic compounds produced by cold acid unit extraction of saturated and unsaturated aliphatic hydrocarbons usually ranging in carbon numbers from C3 through C6, predominantly pentanes and amylenes. It consists predominantly of saturated and unsaturated hydrocarbons having carbon numbers in the range of C4 through C6, predominantly C5. EC / List no: 270-741-4 CAS no: 68477-61-2
EU CLP (1272/2008)
Carc. 1B; Muta. 1B; Asp. Tox. 1