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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Extract residues (coal), light oil alk., indene naphtha fraction; Light Oil Extract Residues, high boiling [The distillate from aromatic hydrocarbons, coumarone, naphthalene and indene rich prefractionator bottoms or washed Carbolic oils, having an approximate boiling range of 155o C to 180o C (311 °F to 356 °F). Composed primarily of indene, indan and trimethylbenzenes.]

The distillate from aromatic hydrocarbons, coumarone, naphthalene and indene rich prefractionator bottoms or washed carbolic oils, having an approximate boiling range of 155°C to 180°C (311°F to 356°F). Composed primarily of indene, indan and trimethylbenzenes. EC / List no: 292-626-8 CAS no: 90641-03-5
EU CLP (1272/2008)
Carc. 1B; Muta. 1B