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).

Last updated 13 rujna 2024. Database contains 4917 unique substances/entries.
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Acute Tox. 2; Acute Tox. 1
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Acute Tox. 4
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Acute Tox. 4
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HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
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Perfluorohexane-1-sulphonic acid EC / List no: 206-587-1 | CAS no: 355-46-4
Ammonium perfluorohexane-1-sulphonate EC / List no: 269-511-6 | CAS no: 68259-08-5
N,N,N-triethylethanaminium tridecafluorohexane-1-sulfonate EC / List no: - | CAS no: 108427-55-0
Potassium perfluorohexane-1-sulphonate EC / List no: 223-393-2 | CAS no: 3871-99-6
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VPVB very Persistent and very Bioaccumulative (article 57e)
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Acute Tox. 2
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Unst. Expl.; Acute Tox. 3
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Acute Tox. 2
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Acute Tox. 2
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Acute Tox. 4
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