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).

Tar acids, cresylic, residues; Distillate Phenols [The residue from crude coal tar acids after removal of phenol, cresols, xylenols and any higher boiling phenols. A black solid with a melting point approximately 80 °C (176°F). Composed primarily of polyalkylphenols, resin gums, and inorganic salts.]

The residue from crude coal tar acids after removal of phenol, cresols, xylenols and any higher boiling phenols. A black solid with a melting point approximately 80°C (176°F). Composed primarily of polyalkylphenols, resin gums, and inorganic salts. EC / List no: 271-418-0 CAS no: 68555-24-8
EU CLP (1272/2008)
Carc. 1B; Muta. 1B