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 14 lipnja 2024. Database contains 4917 unique substances/entries.
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2-ethylhexanoic acid EC / List no: 205-743-6 | CAS no: 149-57-5
Metal salts of 2-ethylhexanoic acid EC / List no: - | CAS no: -
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Repr. 1B
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15271-41-7
Acute Tox. 2; Acute Tox. 3
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2532-43-6
Acute Tox. 3
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4,4'-oxydianiline EC / List no: 202-977-0 | CAS no: 101-80-4
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Carc. 1B; Muta. 1B; Repr. 2; Acute Tox. 3
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ENDE Endocrine disrupting properties (Article 57(f) - environment)
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R Toxic for reproduction (article 57c)
ENDE Endocrine disrupting properties (Article 57(f) - environment)
END Endocrine disrupting properties (Article 57(f) - human health)
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ENDE Endocrine disrupting properties (Article 57(f) - environment)
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ENDE Endocrine disrupting properties (Article 57(f) - environment)
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ENDE Endocrine disrupting properties (Article 57(f) - environment)
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51-14-9
Acute Tox. 4
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VPVB very Persistent and very Bioaccumulative (article 57e)
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VPVB very Persistent and very Bioaccumulative (article 57e)
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VPVB very Persistent and very Bioaccumulative (article 57e)
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10027-06-2
Acute Tox. 4; Skin Irrit. 2; Skin Sens. 1
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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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P Parasites
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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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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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E Equivalent level of concern having probable serious effects to the environment (Article 57(f) - environment)
HH Equivalent level of concern having probable serious effects to human health (Article 57(f) - human health)
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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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