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 17 svibnja 2024. Database contains 4917 unique substances/entries.
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203-300-1
105-46-4
Flam. Liq. 2
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205-801-0
152-16-9
Acute Tox. 1; Acute Tox. 2
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P Parasites
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P Parasites
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P Parasites
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P Parasites
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P Parasites
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F Fungi
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F Fungi
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P Parasites
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V Viruses: Member States are to ensure that all viruses which have already been isolated in humains and which have not been assessed and allocated in this Annex are classified in group 2 as a minimum, except where Member States have proof that they are unlikely to cause disease in humans.
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Acute Tox. 4
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Acute Tox. 2
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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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Potassium perfluorohexane-1-sulphonate EC / List no: 223-393-2 | CAS no: 3871-99-6
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
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VPVB very Persistent and very Bioaccumulative (article 57e)
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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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Acute Tox. 4
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Acute Tox. 4
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Acute Tox. 2; Acute Tox. 1
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Acute Tox. 4; Skin Irrit. 2; Eye Dam. 1
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3,5-Diiodo-4-hydroxybenzonitrile, lithium salt EC / List no: - | CAS no: 2961-61-7
Sodium 4-hydroxy-3,5-diiodophenylcyanide EC / List no: 220-995-7 | CAS no: 2961-62-8
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Repr. 2; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Eye Irrit. 2
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Acute Tox. 2
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Acute Tox. 2; Acute Tox. 1
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