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).

Petroleum products, refinery gases; Refinery gas [A complex combination which consists primarily of hydrogen with various small amounts of methane, ethane, and propane.]

A complex combination which consists primarily of hydrogen with various small amounts of methane, ethane, and propane. EC / List no: 271-750-6 CAS no: 68607-11-4
EU CLP (1272/2008)
Press. Gas; Flam. Gas 1; Carc. 1A; Muta. 1B