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).

2,5-bis-isocyanatomethyl-bicyclo[2.2.1]heptane

MR-8A; MR-N2; NBDI EC / List no: 411-280-2 CAS no: 161973-12-2
EU CLP (1272/2008)
Acute Tox. 2; Acute Tox. 4; Skin Corr. 1B; Resp. Sens. 1; Skin Sens. 1