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 18 lipnja 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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22454-04-2
R Toxic for reproduction (article 57c)
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14890-53-0
R Toxic for reproduction (article 57c)
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25747-83-5
R Toxic for reproduction (article 57c)
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215-604-1
1333-73-9
R Toxic for reproduction (article 57c)
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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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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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P Parasites
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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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223-445-4
3896-11-5
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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B Bacteria and similar species
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B Bacteria and similar species
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202-318-7
94-26-8
END Endocrine disrupting properties (Article 57(f) - human health)
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208-953-6
548-62-9
C Carcinogenic (article 57a)
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640-998-0
7790-78-5
C Carcinogenic (article 57a)
M Mutagen (article 57b)
R Toxic for reproduction (article 57c)
HH2 Specific target organ toxicity after repeated exposure (Article 57(f) - human health)
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C Carcinogenic (article 57a)
M Mutagen (article 57b)
HH2 Specific target organ toxicity after repeated exposure (Article 57(f) - human health)
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Sulfuric acid, cadmium salt, hydrate (3:3:8) EC / List no: 616-572-5 | CAS no: 7790-84-3
Sulfuric acid, cadmium salt (1:1), hydrate EC / List no: 626-360-4 | CAS no: 15244-35-6
233-331-6
10124-36-4;31119-53-6
C Carcinogenic (article 57a)
M Mutagen (article 57b)
R Toxic for reproduction (article 57c)
HH2 Specific target organ toxicity after repeated exposure (Article 57(f) - human health)
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231-152-8
7440-43-9
C Carcinogenic (article 57a)
HH2 Specific target organ toxicity after repeated exposure (Article 57(f) - human health)
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231-904-5
7778-44-1
C Carcinogenic (article 57a)
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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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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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F Fungi
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F Fungi
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P Parasites
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P Parasites
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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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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
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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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231-801-5
7738-94-5
C Carcinogenic (article 57a)
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F Fungi
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P Parasites
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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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