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 With few exceptions specified in Articles 112 and 113 of this Regulation, Directive 98/79/EC is repealed, and the rules pursuant to 2017/746/EU apply, from 26 May 2022.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 19 srpnja 2024. Database contains 4821 unique substances/entries.
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216-768-7
1663-39-4
Flam. Liq. 2; Acute Tox. 4; STOT SE 3; Skin Irrit. 2; Skin Sens. 1
212-105-0
762-75-4
Flam. Liq. 2; Eye Irrit. 2; STOT SE 3
200-915-7
75-91-2
Muta. 2
216-653-1
1634-04-4
Flam. Liq. 2; Skin Irrit. 2
208-757-0
540-80-7
Flam. Liq. 2; Acute Tox. 4
606-566-0
20487-40-5
Flam. Liq. 2
222-389-8
3457-61-2
Org. Perox. E; Skin Irrit. 2
TERTIARYBUTYLARSINE; TERTIÄRBUTYLARSIN
423-320-6
4262-43-5
Pyr. Liq. 1; Acute Tox. 2
MJR-580
418-520-5
183130-96-3
Eye Irrit. 2
C.I. DIRECT BLUE 301; DIRECT BLUE 301
408-210-8
124605-82-9
Skin Sens. 1

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