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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Phenols, ammonia liquor ext.; Alkaline Extract [The combination of phenols extracted, using isobutyl acetate, from the ammonia liquor condensed from the gas evolved in low-temperature (less than 700 °C (1292°F)) destructive distillation of coal. It consists predominantly of a reaction mass of monohydric and dihydric phenols.]

The combination of phenols extracted, using isobutyl acetate, from the ammonia liquor condensed from the gas evolved in low-temperature (less than 700°C (1292°F)) destructive distillation of coal. It consists predominantly of a mixture of monohydric and dihydric phenols. EC / List no: 284-881-9 CAS no: 84988-93-2
EU CLP (1272/2008)
Carc. 1B; Muta. 1B