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 15 srpnja 2024. Database contains 4917 unique substances/entries.
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915-270-3
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R Toxic for reproduction (article 57c)
Details
473-390-7
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VPVB very Persistent and very Bioaccumulative (article 57e)
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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.
Details
This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 77588.
232-382-1
8012-00-8
R Toxic for reproduction (article 57c)
Details
204-927-3
129-00-0
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
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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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68583-29-9
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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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.
Details
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B Bacteria and similar species
Details
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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.
Details
223-393-2
3871-99-6
VPVB very Persistent and very Bioaccumulative (article 57e)
Details
701-468-5
21049-36-5
R Toxic for reproduction (article 57c)
PBT Persistent, Bioaccumulative and Toxic (article 57d)
VPVB very Persistent and very Bioaccumulative (article 57e)
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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C Carcinogenic (article 57a)
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266-578-3
67118-55-2
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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B Bacteria and similar species
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618-541-1
9036-19-5
ENDE Endocrine disrupting properties (Article 57(f) - environment)
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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.
Details
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B Bacteria and similar species
Details

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