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 27 svibnja 2024. Database contains 4917 unique substances/entries.
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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B Bacteria and similar species
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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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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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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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DESBIMID
401-970-1
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Skin Sens. 1
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Muta. 2; Repr. 1B
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473-390-7
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VPVB very Persistent and very Bioaccumulative (article 57e)
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KAYARAD R-825
405-360-6
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Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
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ADINE CP 31
401-740-0
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Acute Tox. 4
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915-270-3
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R Toxic for reproduction (article 57c)
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Repr. 1B
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Repr. 1B
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PK 323
401-940-8
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Acute Tox. 4; Eye Irrit. 2
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X 3761
400-930-0
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Skin Irrit. 2; Eye Dam. 1; Skin Sens. 1
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SUBSTANCE S166075
424-270-8
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Eye Dam. 1
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UNISOL S
405-760-0
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Eye Dam. 1; Skin Sens. 1
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EMULGATOR SWA; EMULVIN SWA
406-325-8
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Acute Tox. 4
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430-200-7
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Eye Dam. 1
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ETHOXYLATED POLYESTER RESIN
405-960-8
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Skin Sens. 1
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LOVASTATIN FREE ACID
415-840-7
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Skin Sens. 1
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442-480-8
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Org. Perox. C; Acute Tox. 4; Skin Corr. 1B; Skin Sens. 1
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