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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 21 lipnja 2024. Database contains 4821 unique substances/entries.
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231-592-0
7646-85-7
Acute Tox. 4; Skin Corr. 1B
238-270-9
14324-55-1
Acute Tox. 4; Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
205-232-8
136-23-2
Eye Irrit. 2; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
Z-6
402-280-3
149144-82-1
Eye Irrit. 2; Skin Irrit. 2
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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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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.
219-364-9
2425-10-7
Acute Tox. 4
215-091-4
1300-73-8
Acute Tox. 3; STOT RE 2
215-089-3
1300-71-6
Acute Tox. 3; Skin Corr. 1B
215-535-7
1330-20-7
Flam. Liq. 3; Acute Tox. 4; Skin Irrit. 2
607-955-8
2655-14-3
Acute Tox. 4
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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.
601-810-2
12185-10-3
Pyr. Sol. 1; Acute Tox. 2; Skin Corr. 1A
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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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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.
The combination of wastes formed by the coking of bituminous coal tar pitch. It consists predominantly of carbon.
295-549-8
92062-34-5
Carc. 1B
201-377-6
81-81-2
Repr. 1A; Acute Tox. 1; Acute Tox. 2; STOT RE 1
200-831-0
75-01-4
Press. Gas; Flam. Gas 1; Carc. 1A
203-545-4
108-05-4
Flam. Liq. 2; Carc. 2; Acute Tox. 4; STOT SE 3

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