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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turpentine, oil

Any of the volatile predominately terpenic fractions or distillates resulting from the solvent extraction of, gum collection from, or pulping of softwoods. Composed primarily of the C10H16 terpene hydrocarbons: α-pinene, β-pinene, limonene, 3-carene, camphene. May contain other acyclic, monocyclic, or bicyclic terpenes, oxygenated terpenes, and anethole. Exact composition varies with refining methods and the age, location, and species of the softwood source. EC / List no: 232-350-7 CAS no: 8006-64-2
EU CLP (1272/2008)
Flam. Liq. 3; Acute Tox. 4; Asp. Tox. 1; Eye Irrit. 2; Skin Irrit. 2; Skin Sens. 1