EU-IN_VITRO_MEDICAL_DEVICES-ART_3_ANX_1

In Vitro Diagnostic Medical Devices Directive - Hazardous Substances

EU. Hazardous Substances for Purposes of Article 3 & Annex I (Essential Requirements), Directive 98/79/EC on In Vitro Diagnostic Medical Devices, 7 December 1998

This list contains a non-exhaustive inventory of hazardous substances for purposes of essential requirements (Article 3 and Annex I) for general safety, design, manufacture and hazard communication of in vitro diagnostic medical devices. It 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). Note that Regulation 2017/746/EU on in vitro diagnostic medical devices was published in the EU Official Journal on 5 May 2017. With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.

Last updated 14 lipnja 2024. Database contains 4821 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
215-604-1
1333-73-9
yes
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25747-83-5
yes
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14890-53-0
yes
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22454-04-2
yes
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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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125022-34-6
yes
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90568-23-3
yes
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F Fungi
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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.
200-268-0
56-35-9
yes
214-604-9
1163-19-5
yes
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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.
603-802-4
134237-51-7
yes
205-883-8
191-24-2
yes
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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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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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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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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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F Fungi
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P Parasites
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P Parasites
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B Bacteria and similar species
204-371-1
120-12-7
yes
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P Parasites
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P Parasites
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P Parasites
269-511-6
68259-08-5
yes
700-242-3
62037-80-3
yes
604-314-4
142844-00-6
yes
603-801-9
134237-50-6
yes
263-004-3
61788-76-9
yes
272-924-4
68920-70-7
yes
285-195-2
85049-26-9
yes
283-931-7
84776-07-8
yes
701-376-5
1372804-76-6
yes
287-504-6
85536-22-7
yes
283-930-1
84776-06-7
yes

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