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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 15 listopada 2024. Database contains 4821 unique substances/entries.
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201-280-9
80-46-6
yes
201-279-3
80-43-3
Org. Perox. F; Repr. 1B; Skin Irrit. 2; Eye Irrit. 2
201-274-6
80-38-6
Acute Tox. 4; Eye Irrit. 2
201-270-4
80-33-1
Acute Tox. 4; Skin Irrit. 2
201-254-7
80-15-9
Org. Perox. E; Acute Tox. 3; Acute Tox. 4; STOT RE 2; Skin Corr. 1B
201-248-4
80-08-0
Acute Tox. 4
201-246-3
80-06-8
Acute Tox. 4
201-245-8
80-05-7
Repr. 1B; STOT SE 3; Eye Dam. 1; Skin Sens. 1
yes
HEXACONAZOLE
413-050-7
79983-71-4
Acute Tox. 4; Skin Sens. 1
AMINODIOXEPAN
419-050-3
79944-37-9
Skin Sens. 1

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