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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Hydrocarbons, C1-3; Petroleum gas [A complex combination of hydrocarbons having carbon numbers predominantly in the range of C1 through C3 and boiling in the range of approxi mately minus 164 °C to minus 42 °C (- 263 °F to - 44 °F).]

A complex combination of hydrocarbons having carbon numbers predominantly in the range of C1 through C3 and boiling in the range of approximately minus 164°C to minus 42°C (-263°F to -44°F). EC / List no: 271-259-7 CAS no: 68527-16-2
EU CLP (1272/2008)
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B