EU-IN_VITRO_MEDICAL_DEVICE_REG-ART_5_2_ANX_1

In Vitro Diagnostic Medical Devices Regulation - Hazardous Substances

EU. Hazardous Substances for Purposes of Art. 5(2) and Annex I of Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices, 5 May 2017, as corrected 27 December 2019

This list contains a non-exhaustive inventory of hazardous substances for purposes of Regulation (EU) 2017/746, including Chap. 2 (Placing on the market and putting into service) and Annex I (General Safety and Performance Requirements). It 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).

Paraffin oils (petroleum), solvent-refined dewaxed heavy; Baseoil — unspecified [A complex combination of hydrocarbons obtained from sulfur-containing paraffinic crude oil. It consists predominantly of a solvent refined deparaffinated lubricating oil with a viscosity of 65cSt at 50 °C.]

A complex combination of hydrocarbons obtained from sulfur-containing paraffinic crude oil. It consists predominantly of a solvent refined deparaffinated lubricating oil with a viscosity of 65cSt at 50°C. EC / List no: 295-810-6 CAS no: 92129-09-4
EU CLP (1272/2008)
Carc. 1B