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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 12 rujna 2024. Database contains 4821 unique substances/entries.
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444-350-6
133413-70-4
Eye Irrit. 2
444-320-2
-
Acute Tox. 4
444-290-0
508202-43-5
Eye Dam. 1; Skin Sens. 1
444-250-2
144111-81-9
Self-react. C
444-050-5
-
Eye Dam. 1
443-980-9
221215-20-9
Skin Sens. 1
443-870-0
163520-33-0
Acute Tox. 4; Skin Sens. 1
443-840-7
4084-38-2
Acute Tox. 4; Eye Irrit. 2; Skin Sens. 1
443-560-5
88784-33-2
Eye Irrit. 2
443-150-6
101226-85-1
Flam. Liq. 3

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