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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stoddard solvent; Low boiling point naphtha —; unspecified [A colourless, refined petroleum distillate that is free from rancid or objectionable odours and that boils in a range of approximately 148,8 °C to 204,4 o C (300°F to 400°F).]

A colorless, refined petroleum distillate that is free from rancid or objectionable odors and that boils in a range of approximately 148.8°C to 204.4°C (300°F to 400°F). EC / List no: 232-489-3 CAS no: 8052-41-3
EU CLP (1272/2008)
Carc. 1B; Muta. 1B; STOT RE 1; Asp. Tox. 1