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).

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Distillates (petroleum), alkene-alkyne manuf. pyrolysis oil, mixed with high-temp. coal tar, indene fraction; Redistillates [A complex combination of hydrocarbons obtained as a redistillate from the fractional distillation of bituminous coal high temperature tar and residual oils that are obtained by the pyrolytic production of alkenes and alkynes from petroleum products or natural gas. It consists predominantly of indene and boils in a range of approximately160 o C to 190 o C (320 °F to 374 °F).]

A complex combination of hydrocarbons obtained as a redistillate from the fractional distillation of bituminous coal high temperature tar and residual oils that are obtained by the pyrolytic production of alkenes and alkynes from petroleum products or natural gas. It consists predominantly of indene and boils in a range of approximately 160°C to 190°C (320°F to 374°F). EC / List no: 295-292-1 CAS no: 91995-31-2
EU CLP (1272/2008)
Carc. 1B; Muta. 1B