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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 04 listopada 2024. Database contains 4821 unique substances/entries.
Filter the list

RED E190
411-560-4
-
STOT RE 1; Skin Sens. 1
AF-376
407-740-7
138427-56-2
Skin Irrit. 2; Skin Sens. 1
428-050-2
-
Skin Sens. 1
VIKOFLEX 9080
414-890-7
71302-79-9
Skin Sens. 1
SPE 93279
414-420-0
-
Eye Dam. 1
419-000-0
-
Skin Sens. 1
EUGEWHITE
412-020-0
-
Skin Sens. 1
FLORASANTOL
415-990-3
67739-11-1
Eye Irrit. 2
MMA-10R
423-670-1
-
Eye Dam. 1; Skin Sens. 1
UVA RAR 1018
423-520-3
156137-33-6
Skin Sens. 1

Export search results to: